Trial Outcomes & Findings for Clinical Trial for Parkinson's Disease Using Allogeneic HB-adMSCs (Early and Moderate PD) (NCT NCT04995081)
NCT ID: NCT04995081
Last Updated: 2026-06-10
Results Overview
Clinically significant changes in MDS-UPDRS Part III. The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total). Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe. The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability). Higher values represent a worse outcome.
COMPLETED
PHASE2
60 participants
Baseline to Weeks 52
2026-06-10
Participant Flow
Participant milestones
| Measure |
Allogeneic HB-adMSCs.
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
Placebo
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
28
|
23
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Trial for Parkinson's Disease Using Allogeneic HB-adMSCs (Early and Moderate PD)
Baseline characteristics by cohort
| Measure |
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=9 Participants
|
19 Participants
n=27 Participants
|
34 Participants
n=267 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=9 Participants
|
11 Participants
n=27 Participants
|
26 Participants
n=267 Participants
|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 10.82 • n=9 Participants
|
60.8 years
STANDARD_DEVIATION 9.83 • n=27 Participants
|
62.0 years
STANDARD_DEVIATION 10.32 • n=267 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=9 Participants
|
11 Participants
n=27 Participants
|
21 Participants
n=267 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=9 Participants
|
19 Participants
n=27 Participants
|
39 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
9 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=9 Participants
|
28 Participants
n=27 Participants
|
51 Participants
n=267 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=9 Participants
|
2 Participants
n=27 Participants
|
6 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=9 Participants
|
28 Participants
n=27 Participants
|
54 Participants
n=267 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=267 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=9 Participants
|
30 participants
n=27 Participants
|
60 participants
n=267 Participants
|
|
Height
|
172.73 centimeters
STANDARD_DEVIATION 8.493 • n=9 Participants
|
172.68 centimeters
STANDARD_DEVIATION 10.875 • n=27 Participants
|
172.71 centimeters
STANDARD_DEVIATION 9.674 • n=267 Participants
|
|
Weight
|
78.87 kilograms
STANDARD_DEVIATION 15.915 • n=9 Participants
|
77.08 kilograms
STANDARD_DEVIATION 16.155 • n=27 Participants
|
77.98 kilograms
STANDARD_DEVIATION 15.924 • n=267 Participants
|
|
BMI
|
26.34 kilograms/(meters*meters)
STANDARD_DEVIATION 4.542 • n=9 Participants
|
25.73 kilograms/(meters*meters)
STANDARD_DEVIATION 4.266 • n=27 Participants
|
26.03 kilograms/(meters*meters)
STANDARD_DEVIATION 4.379 • n=267 Participants
|
|
Carbidopa/Levodopa Dose
<= 500 mg/day
|
17 Participants
n=9 Participants
|
16 Participants
n=27 Participants
|
33 Participants
n=267 Participants
|
|
Carbidopa/Levodopa Dose
> 500 mg/day
|
13 Participants
n=9 Participants
|
14 Participants
n=27 Participants
|
27 Participants
n=267 Participants
|
|
MDS-UPDRS Part II + III Total Scores
<= 50
|
18 Participants
n=9 Participants
|
21 Participants
n=27 Participants
|
39 Participants
n=267 Participants
|
|
MDS-UPDRS Part II + III Total Scores
> 50
|
12 Participants
n=9 Participants
|
9 Participants
n=27 Participants
|
21 Participants
n=267 Participants
|
PRIMARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Clinically significant changes in MDS-UPDRS Part III. The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total). Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe. The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability). Higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in MDS-UPDRS Part III Total Score
Infusion 2 (Visit 3 - Week 4)
|
-2.22 Score on a scale (132 points total)
Standard Deviation 8.29
|
-2.24 Score on a scale (132 points total)
Standard Deviation 7.20
|
|
Change From Baseline in MDS-UPDRS Part III Total Score
Infusion 3 (Visit 4 - Week 8)
|
-1.70 Score on a scale (132 points total)
Standard Deviation 9.44
|
-2.69 Score on a scale (132 points total)
Standard Deviation 10.39
|
|
Change From Baseline in MDS-UPDRS Part III Total Score
Infusion 4 (Visit 5 - Week 12)
|
-2.11 Score on a scale (132 points total)
Standard Deviation 9.83
|
-5.59 Score on a scale (132 points total)
Standard Deviation 10.37
|
|
Change From Baseline in MDS-UPDRS Part III Total Score
Infusion 5 (Visit 6 - Week 16)
|
-2.96 Score on a scale (132 points total)
Standard Deviation 10.23
|
-7.17 Score on a scale (132 points total)
Standard Deviation 10.66
|
|
Change From Baseline in MDS-UPDRS Part III Total Score
Infusion 6 (Visit 7 - Week 20)
|
-1.37 Score on a scale (132 points total)
Standard Deviation 11.49
|
-11.14 Score on a scale (132 points total)
Standard Deviation 10.99
|
|
Change From Baseline in MDS-UPDRS Part III Total Score
End of Study (Visit 8 - Week 52)
|
1.77 Score on a scale (132 points total)
Standard Deviation 13.39
|
-2.74 Score on a scale (132 points total)
Standard Deviation 15.68
|
PRIMARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Clinically significant changes in MDS-UPDRS Part III. The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total). Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe. The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability). Higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in MDS-UPDRS Part III (Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
-1.996 Score on a scale (132 points total)
Standard Error 1.421
|
-1.609 Score on a scale (132 points total)
Standard Error 1.421
|
|
Change From Baseline in MDS-UPDRS Part III (Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
-1.663 Score on a scale (132 points total)
Standard Error 1.795
|
-0.609 Score on a scale (132 points total)
Standard Error 1.795
|
|
Change From Baseline in MDS-UPDRS Part III (Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
-1.579 Score on a scale (132 points total)
Standard Error 1.643
|
-4.234 Score on a scale (132 points total)
Standard Error 1.643
|
|
Change From Baseline in MDS-UPDRS Part III (Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
-2.371 Score on a scale (132 points total)
Standard Error 2.064
|
-6.193 Score on a scale (132 points total)
Standard Error 2.064
|
|
Change From Baseline in MDS-UPDRS Part III (Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
-0.496 Score on a scale (132 points total)
Standard Error 2.018
|
-9.818 Score on a scale (132 points total)
Standard Error 2.018
|
|
Change From Baseline in MDS-UPDRS Part III (Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
0.597 Score on a scale (132 points total)
Standard Error 3.350
|
0.124 Score on a scale (132 points total)
Standard Error 3.150
|
PRIMARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Clinically significant changes in MDS-UPDRS Part III. The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total). Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe. The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability). Higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in MDS-UPDRS Part III (Bayesian Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
-5.622 Score on a scale (132 points total)
Standard Deviation 2.020
|
-5.211 Score on a scale (132 points total)
Standard Deviation 1.928
|
|
Change From Baseline in MDS-UPDRS Part III (Bayesian Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
-6.264 Score on a scale (132 points total)
Standard Deviation 2.259
|
-4.873 Score on a scale (132 points total)
Standard Deviation 2.213
|
|
Change From Baseline in MDS-UPDRS Part III (Bayesian Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
-5.178 Score on a scale (132 points total)
Standard Deviation 2.211
|
-6.290 Score on a scale (132 points total)
Standard Deviation 2.126
|
|
Change From Baseline in MDS-UPDRS Part III (Bayesian Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
-5.242 Score on a scale (132 points total)
Standard Deviation 2.420
|
-6.569 Score on a scale (132 points total)
Standard Deviation 2.362
|
|
Change From Baseline in MDS-UPDRS Part III (Bayesian Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
-3.220 Score on a scale (132 points total)
Standard Deviation 2.388
|
-8.736 Score on a scale (132 points total)
Standard Deviation 2.340
|
|
Change From Baseline in MDS-UPDRS Part III (Bayesian Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
-6.316 Score on a scale (132 points total)
Standard Deviation 2.389
|
-6.913 Score on a scale (132 points total)
Standard Deviation 2.518
|
PRIMARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part III tests Motor Examination, which tests speech, facial expression, rigidity, finger and hand movement, pronation-supination movements of hands, toe tapping, leg agility, arising from chair, gait, freezing of gait, postural stability, posture, global spontaneity of movement, postural tremor of the hands, kinetic tremor of the hands, rest tremor amplitude, constancy of rest tremor, dyskinesias impact and Hoehn and Yahr stage (18 items total). Each item is rated from 0-4: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The Part III score ranges from 0 - 132; 32 and below is mild, 59 and above is severe. The total MDS-UPDRS Parts I-IV score ranges from 0 (no disability) to 260 (total disability). Higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part III Score - by Treatment Week
Infusion 2 (Visit 3 - Week 4) · Yes
|
12 Participants
|
10 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part III Score - by Treatment Week
Infusion 2 (Visit 3 - Week 4) · No
|
15 Participants
|
19 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part III Score - by Treatment Week
Infusion 3 (Visit 4 - Week 8) · Yes
|
10 Participants
|
13 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part III Score - by Treatment Week
Infusion 3 (Visit 4 - Week 8) · No
|
17 Participants
|
16 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part III Score - by Treatment Week
Infusion 4 (Visit 5 - Week 12) · Yes
|
13 Participants
|
16 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part III Score - by Treatment Week
Infusion 4 (Visit 5 - Week 12) · No
|
14 Participants
|
13 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part III Score - by Treatment Week
Infusion 5 (Visit 6 - Week 16) · Yes
|
12 Participants
|
19 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part III Score - by Treatment Week
Infusion 5 (Visit 6 - Week 16) · No
|
15 Participants
|
10 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part III Score - by Treatment Week
Infusion 6 (Visit 7 - Week 20) · Yes
|
11 Participants
|
21 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part III Score - by Treatment Week
Infusion 6 (Visit 7 - Week 20) · No
|
16 Participants
|
7 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part III Score - by Treatment Week
End of Study (Visit 8 - Week 52) · Yes
|
8 Participants
|
18 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part III Score - by Treatment Week
End of Study (Visit 8 - Week 52) · No
|
14 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Clinically significant changes in MDS-UPDRS Part II.The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in MDS-UPDRS Part II Total Score
Infusion 2 (Visit 3 - Week 4)
|
-2.15 Score on a scale (52 points total)
Standard Deviation 4.04
|
0.97 Score on a scale (52 points total)
Standard Deviation 3.70
|
|
Change From Baseline in MDS-UPDRS Part II Total Score
Infusion 3 (Visit 4 - Week 8)
|
-2.26 Score on a scale (52 points total)
Standard Deviation 4.27
|
-0.62 Score on a scale (52 points total)
Standard Deviation 3.90
|
|
Change From Baseline in MDS-UPDRS Part II Total Score
Infusion 4 (Visit 5 - Week 12)
|
-1.70 Score on a scale (52 points total)
Standard Deviation 4.26
|
-0.38 Score on a scale (52 points total)
Standard Deviation 4.49
|
|
Change From Baseline in MDS-UPDRS Part II Total Score
Infusion 5 (Visit 6 - Week 16)
|
-1.74 Score on a scale (52 points total)
Standard Deviation 4.21
|
-0.79 Score on a scale (52 points total)
Standard Deviation 5.58
|
|
Change From Baseline in MDS-UPDRS Part II Total Score
Infusion 6 (Visit 7 - Week 20)
|
-1.56 Score on a scale (52 points total)
Standard Deviation 3.25
|
-1.14 Score on a scale (52 points total)
Standard Deviation 4.57
|
|
Change From Baseline in MDS-UPDRS Part II Total Score
End of Study (Visit 8 - Week 52)
|
0.05 Score on a scale (52 points total)
Standard Deviation 5.11
|
-0.70 Score on a scale (52 points total)
Standard Deviation 6.45
|
PRIMARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Clinically significant changes in MDS-UPDRS Part II.The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Changes From Baseline in MDS-UPDRS Part II (Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
-1.997 Score on a scale (52 points total)
Standard Error 0.708
|
0.519 Score on a scale (52 points total)
Standard Error 0.708
|
|
Changes From Baseline in MDS-UPDRS Part II (Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
-2.122 Score on a scale (52 points total)
Standard Error 0.746
|
-0.356 Score on a scale (52 points total)
Standard Error 0.746
|
|
Changes From Baseline in MDS-UPDRS Part II (Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
-1.497 Score on a scale (52 points total)
Standard Error 0.846
|
-0.481 Score on a scale (52 points total)
Standard Error 0.846
|
|
Changes From Baseline in MDS-UPDRS Part II (Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
-1.580 Score on a scale (52 points total)
Standard Error 0.885
|
-1.272 Score on a scale (52 points total)
Standard Error 0.885
|
|
Changes From Baseline in MDS-UPDRS Part II (Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
-1.414 Score on a scale (52 points total)
Standard Error 0.743
|
-1.481 Score on a scale (52 points total)
Standard Error 0.743
|
|
Changes From Baseline in MDS-UPDRS Part II (Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
0.056 Score on a scale (52 points total)
Standard Error 1.155
|
-0.400 Score on a scale (52 points total)
Standard Error 1.085
|
PRIMARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Clinically significant changes in MDS-UPDRS Part II.The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in MDS-UPDRS Part II (Bayesian Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
-2.298 Score on a scale (52 points total)
Standard Deviation 1.393
|
0.293 Score on a scale (52 points total)
Standard Deviation 1.297
|
|
Change From Baseline in MDS-UPDRS Part II (Bayesian Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
-1.933 Score on a scale (52 points total)
Standard Deviation 1.409
|
-0.079 Score on a scale (52 points total)
Standard Deviation 1.313
|
|
Change From Baseline in MDS-UPDRS Part II (Bayesian Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
-1.624 Score on a scale (52 points total)
Standard Deviation 1.460
|
0.422 Score on a scale (52 points total)
Standard Deviation 1.377
|
|
Change From Baseline in MDS-UPDRS Part II (Bayesian Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
-1.321 Score on a scale (52 points total)
Standard Deviation 1.488
|
-0.750 Score on a scale (52 points total)
Standard Deviation 1.384
|
|
Change From Baseline in MDS-UPDRS Part II (Bayesian Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
-1.105 Score on a scale (52 points total)
Standard Deviation 1.412
|
-0.940 Score on a scale (52 points total)
Standard Deviation 1.316
|
|
Change From Baseline in MDS-UPDRS Part II (Bayesian Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
-1.636 Score on a scale (52 points total)
Standard Deviation 1.504
|
-1.246 Score on a scale (52 points total)
Standard Deviation 1.452
|
PRIMARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. The MDS-UPDRS scale consists of 4 segments. Part II tests "Motor Aspects of Experiences of Daily Living". Each answer to the scale is evaluated by the principal investigator during the study visit. Some sections of the MDS-UPDRS scale require multiple grades assigned to each extremity. There are 13 items included in Part II. Part II score ranges from 0 - 52; 12 and below is mild, 30 and above is severe. Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part II Score - by Treatment Week
Infusion 6 (Visit 7 - Week 20) · No
|
19 Participants
|
21 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part II Score - by Treatment Week
Infusion 2 (Visit 3 - Week 4) · Yes
|
8 Participants
|
3 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part II Score - by Treatment Week
Infusion 2 (Visit 3 - Week 4) · No
|
19 Participants
|
26 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part II Score - by Treatment Week
Infusion 3 (Visit 4 - Week 8) · Yes
|
9 Participants
|
5 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part II Score - by Treatment Week
Infusion 3 (Visit 4 - Week 8) · No
|
18 Participants
|
24 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part II Score - by Treatment Week
Infusion 4 (Visit 5 - Week 12) · Yes
|
6 Participants
|
7 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part II Score - by Treatment Week
Infusion 4 (Visit 5 - Week 12) · No
|
21 Participants
|
22 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part II Score - by Treatment Week
Infusion 5 (Visit 6 - Week 16) · Yes
|
11 Participants
|
9 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part II Score - by Treatment Week
Infusion 5 (Visit 6 - Week 16) · No
|
16 Participants
|
20 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part II Score - by Treatment Week
Infusion 6 (Visit 7 - Week 20) · Yes
|
8 Participants
|
8 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part II Score - by Treatment Week
End of Study (Visit 8 - Week 52) · Yes
|
4 Participants
|
7 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part II Score - by Treatment Week
End of Study (Visit 8 - Week 52) · No
|
18 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in MDS-UPDRS Part I Total Score
Infusion 2 (Visit 3 - Week 4)
|
-1.48 Score on a scale (52 points total)
Standard Deviation 3.02
|
-0.90 Score on a scale (52 points total)
Standard Deviation 4.06
|
|
Change From Baseline in MDS-UPDRS Part I Total Score
Infusion 3 (Visit 4 - Week 8)
|
-1.59 Score on a scale (52 points total)
Standard Deviation 2.94
|
-1.52 Score on a scale (52 points total)
Standard Deviation 4.01
|
|
Change From Baseline in MDS-UPDRS Part I Total Score
Infusion 4 (Visit 5 - Week 12)
|
-2.22 Score on a scale (52 points total)
Standard Deviation 4.06
|
-1.66 Score on a scale (52 points total)
Standard Deviation 3.58
|
|
Change From Baseline in MDS-UPDRS Part I Total Score
Infusion 5 (Visit 6 - Week 16)
|
-2.44 Score on a scale (52 points total)
Standard Deviation 3.57
|
-1.83 Score on a scale (52 points total)
Standard Deviation 5.52
|
|
Change From Baseline in MDS-UPDRS Part I Total Score
Infusion 6 (Visit 7 - Week 20)
|
-2.19 Score on a scale (52 points total)
Standard Deviation 3.51
|
-2.62 Score on a scale (52 points total)
Standard Deviation 6.01
|
|
Change From Baseline in MDS-UPDRS Part I Total Score
End of Study (Visit 8 - Week 52)
|
-0.68 Score on a scale (52 points total)
Standard Deviation 3.66
|
-2.00 Score on a scale (52 points total)
Standard Deviation 5.44
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in MDS-UPDRS Part I (Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
-1.321 Score on a scale (52 points total)
Standard Error 0.612
|
-1.363 Score on a scale (52 points total)
Standard Error 0.612
|
|
Change From Baseline in MDS-UPDRS Part I (Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
-1.613 Score on a scale (52 points total)
Standard Error 0.650
|
-1.821 Score on a scale (52 points total)
Standard Error 0.650
|
|
Change From Baseline in MDS-UPDRS Part I (Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
-1.946 Score on a scale (52 points total)
Standard Error 0.778
|
-1.779 Score on a scale (52 points total)
Standard Error 0.778
|
|
Change From Baseline in MDS-UPDRS Part I (Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
-2.404 Score on a scale (52 points total)
Standard Error 0.921
|
-2.113 Score on a scale (52 points total)
Standard Error 0.921
|
|
Change From Baseline in MDS-UPDRS Part I (Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
-2.113 Score on a scale (52 points total)
Standard Error 1.002
|
-3.196 Score on a scale (52 points total)
Standard Error 1.002
|
|
Change From Baseline in MDS-UPDRS Part I (Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
-0.971 Score on a scale (52 points total)
Standard Error 0.976
|
-2.591 Score on a scale (52 points total)
Standard Error 0.915
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in MDS-UPDRS Part I (Bayesian Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
-2.577 Score on a scale (52 points total)
Standard Deviation 1.004
|
-2.583 Score on a scale (52 points total)
Standard Deviation 0.997
|
|
Change From Baseline in MDS-UPDRS Part I (Bayesian Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
-2.498 Score on a scale (52 points total)
Standard Deviation 1.033
|
-2.660 Score on a scale (52 points total)
Standard Deviation 1.026
|
|
Change From Baseline in MDS-UPDRS Part I (Bayesian Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
-2.726 Score on a scale (52 points total)
Standard Deviation 1.111
|
-2.465 Score on a scale (52 points total)
Standard Deviation 1.093
|
|
Change From Baseline in MDS-UPDRS Part I (Bayesian Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
-2.767 Score on a scale (52 points total)
Standard Deviation 1.188
|
-2.439 Score on a scale (52 points total)
Standard Deviation 1.194
|
|
Change From Baseline in MDS-UPDRS Part I (Bayesian Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
-2.256 Score on a scale (52 points total)
Standard Deviation 1.234
|
-3.039 Score on a scale (52 points total)
Standard Deviation 1.232
|
|
Change From Baseline in MDS-UPDRS Part I (Bayesian Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
-2.463 Score on a scale (52 points total)
Standard Deviation 1.154
|
-3.313 Score on a scale (52 points total)
Standard Deviation 1.161
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The MDS-UPDRS scale refers to Movement Disorder Society - Unified Parkinson Disease Rating Scale, and it is a rating tool used to gauge the course of Parkinson's disease in patients. Part I tests "Nonmotor experiences of daily living". Non-Motor Aspects of Experiences of Daily Living (nM-EDL), including complex behaviors such as, cognitive impairment, hallucinations and psychosis, depressed mood, anxious mood, apathy, features of dopamine dysregulation syndrome, sleep problems, daytime sleepiness, pain and other sensations, urinary problems, constipation problems, light headedness on standing and fatigue. There are 13 items included in Part I. Part I score ranges from 0 - 52; 10 and below is mild, 22 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part I Score - by Treatment Week
Infusion 2 (Visit 3 - Week 4) · Yes
|
9 Participants
|
6 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part I Score - by Treatment Week
Infusion 2 (Visit 3 - Week 4) · No
|
18 Participants
|
23 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part I Score - by Treatment Week
Infusion 3 (Visit 4 - Week 8) · Yes
|
8 Participants
|
7 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part I Score - by Treatment Week
Infusion 3 (Visit 4 - Week 8) · No
|
19 Participants
|
22 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part I Score - by Treatment Week
Infusion 4 (Visit 5 - Week 12) · Yes
|
10 Participants
|
10 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part I Score - by Treatment Week
Infusion 4 (Visit 5 - Week 12) · No
|
17 Participants
|
19 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part I Score - by Treatment Week
Infusion 5 (Visit 6 - Week 16) · Yes
|
10 Participants
|
10 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part I Score - by Treatment Week
Infusion 5 (Visit 6 - Week 16) · No
|
17 Participants
|
19 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part I Score - by Treatment Week
Infusion 6 (Visit 7 - Week 20) · Yes
|
13 Participants
|
11 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part I Score - by Treatment Week
Infusion 6 (Visit 7 - Week 20) · No
|
14 Participants
|
18 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part I Score - by Treatment Week
End of Study (Visit 8 - Week 52) · Yes
|
6 Participants
|
12 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part I Score - by Treatment Week
End of Study (Visit 8 - Week 52) · No
|
16 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Clinically significant changes in MDS-UPDRS Part IV. The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part IV tests "Motor Complications", including time spent with dyskinesias and others. There are 6 items included in Part IV. Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in MDS-UPDRS Part IV Total Score
Infusion 2 (Visit 3 - Week 4)
|
-0.07 Score on a scale (24 points total)
Standard Deviation 4.12
|
-0.34 Score on a scale (24 points total)
Standard Deviation 3.09
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score
Infusion 3 (Visit 4 - Week 8)
|
-0.30 Score on a scale (24 points total)
Standard Deviation 3.79
|
-0.03 Score on a scale (24 points total)
Standard Deviation 2.92
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score
Infusion 4 (Visit 5 - Week 12)
|
-0.37 Score on a scale (24 points total)
Standard Deviation 4.34
|
-1.38 Score on a scale (24 points total)
Standard Deviation 3.28
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score
Infusion 5 (Visit 6 - Week 16)
|
-1.11 Score on a scale (24 points total)
Standard Deviation 3.77
|
-1.90 Score on a scale (24 points total)
Standard Deviation 3.49
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score
Infusion 6 (Visit 7 - Week 20)
|
-1.07 Score on a scale (24 points total)
Standard Deviation 4.04
|
-0.82 Score on a scale (24 points total)
Standard Deviation 3.76
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score
End of Study (Visit 8 - Week 52)
|
0.09 Score on a scale (24 points total)
Standard Deviation 4.77
|
-1.07 Score on a scale (24 points total)
Standard Deviation 4.97
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Clinically significant changes in MDS-UPDRS Part IV. The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part IV tests "Motor Complications", including time spent with dyskinesias and others. There are 6 items included in Part IV. Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in MDS-UPDRS Part IV Total Score (Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
0.161 Score on a scale (24 points total)
Standard Error 0.677
|
-0.696 Score on a scale (24 points total)
Standard Error 0.677
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score (Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
-0.089 Score on a scale (24 points total)
Standard Error 0.651
|
-0.529 Score on a scale (24 points total)
Standard Error 0.651
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score (Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
-0.047 Score on a scale (24 points total)
Standard Error 0.658
|
-2.154 Score on a scale (24 points total)
Standard Error 0.657
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score (Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
-1.006 Score on a scale (24 points total)
Standard Error 0.677
|
-2.529 Score on a scale (24 points total)
Standard Error 0.677
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score (Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
-0.839 Score on a scale (24 points total)
Standard Error 0.653
|
-1.446 Score on a scale (24 points total)
Standard Error 0.653
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score (Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
0.008 Score on a scale (24 points total)
Standard Error 0.886
|
-1.886 Score on a scale (24 points total)
Standard Error 0.812
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Clinically significant changes in MDS-UPDRS Part IV. The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part IV tests "Motor Complications", including time spent with dyskinesias and others. There are 6 items included in Part IV. Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in MDS-UPDRS Part IV Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
-4.800 Score on a scale (24 points total)
Standard Deviation 1.208
|
-5.723 Score on a scale (24 points total)
Standard Deviation 1.193
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
-5.045 Score on a scale (24 points total)
Standard Deviation 1.202
|
-5.510 Score on a scale (24 points total)
Standard Deviation 1.177
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
-4.320 Score on a scale (24 points total)
Standard Deviation 1.202
|
-6.278 Score on a scale (24 points total)
Standard Deviation 1.193
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
-4.600 Score on a scale (24 points total)
Standard Deviation 1.204
|
-5.989 Score on a scale (24 points total)
Standard Deviation 1.200
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
-5.069 Score on a scale (24 points total)
Standard Deviation 1.192
|
-5.527 Score on a scale (24 points total)
Standard Deviation 1.182
|
|
Change From Baseline in MDS-UPDRS Part IV Total Score (Bayesian Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
-4.760 Score on a scale (24 points total)
Standard Deviation 1.240
|
-5.956 Score on a scale (24 points total)
Standard Deviation 1.254
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The Movement Disorder Society - Unified Parkinson Disease Rating Scale, or MDS-UPDRS, is a four-part rating tool used to gauge the progress of Parkinson's disease in patients. Part IV tests "Motor Complications", including time spent with dyskinesias and others. There are 6 items included in Part IV. Part IV score ranges from 0 - 24; 4 and below is mild, 13 and above is severe. Each item has 0-4 ratings:0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). The total score ranges from 0 to 260, with 0 indicating no disability and 260 indicating total disability. Higher values represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part IV Score - by Treatment Week
131End of Study (Visit 8 - Week 52) · Yes
|
12 Participants
|
13 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part IV Score - by Treatment Week
Infusion 2 (Visit 3 - Week 4) · Yes
|
11 Participants
|
9 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part IV Score - by Treatment Week
Infusion 2 (Visit 3 - Week 4) · No
|
16 Participants
|
20 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part IV Score - by Treatment Week
Infusion 3 (Visit 4 - Week 8) · Yes
|
10 Participants
|
9 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part IV Score - by Treatment Week
Infusion 3 (Visit 4 - Week 8) · No
|
17 Participants
|
20 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part IV Score - by Treatment Week
Infusion 4 (Visit 5 - Week 12) · Yes
|
12 Participants
|
12 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part IV Score - by Treatment Week
Infusion 4 (Visit 5 - Week 12) · No
|
15 Participants
|
17 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part IV Score - by Treatment Week
Infusion 5 (Visit 6 - Week 16) · Yes
|
13 Participants
|
15 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part IV Score - by Treatment Week
Infusion 5 (Visit 6 - Week 16) · No
|
14 Participants
|
14 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part IV Score - by Treatment Week
Infusion 6 (Visit 7 - Week 20) · Yes
|
14 Participants
|
14 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part IV Score - by Treatment Week
Infusion 6 (Visit 7 - Week 20) · No
|
13 Participants
|
14 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total MDS-UPDRS Part IV Score - by Treatment Week
131End of Study (Visit 8 - Week 52) · No
|
10 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in SF-36 (Average General Health) Total Score
Infusion 2 (Visit 3 - Week 4)
|
-2.41 Score on a scale (100 points total)
Standard Deviation 11.55
|
1.03 Score on a scale (100 points total)
Standard Deviation 12.20
|
|
Change From Baseline in SF-36 (Average General Health) Total Score
Infusion 3 (Visit 4 - Week 8)
|
-0.74 Score on a scale (100 points total)
Standard Deviation 8.40
|
0.52 Score on a scale (100 points total)
Standard Deviation 12.56
|
|
Change From Baseline in SF-36 (Average General Health) Total Score
Infusion 4 (Visit 5 - Week 12)
|
-2.04 Score on a scale (100 points total)
Standard Deviation 10.49
|
-2.07 Score on a scale (100 points total)
Standard Deviation 12.78
|
|
Change From Baseline in SF-36 (Average General Health) Total Score
Infusion 5 (Visit 6 - Week 16)
|
-3.33 Score on a scale (100 points total)
Standard Deviation 13.08
|
-0.52 Score on a scale (100 points total)
Standard Deviation 10.72
|
|
Change From Baseline in SF-36 (Average General Health) Total Score
Infusion 6 (Visit 7 - Week 20)
|
-5.00 Score on a scale (100 points total)
Standard Deviation 11.60
|
-1.03 Score on a scale (100 points total)
Standard Deviation 11.68
|
|
Change From Baseline in SF-36 (Average General Health) Total Score
End of Study (Visit 8 - Week 52)
|
0.00 Score on a scale (100 points total)
Standard Deviation 8.02
|
0.19 Score on a scale (100 points total)
Standard Deviation 10.42
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in SF-36 (Average Physical Functioning) Total Score
Infusion 2 (Visit 3 - Week 4)
|
2.04 Score on a scale (100 points total)
Standard Deviation 10.21
|
5.34 Score on a scale (100 points total)
Standard Deviation 13.69
|
|
Change From Baseline in SF-36 (Average Physical Functioning) Total Score
Infusion 3 (Visit 4 - Week 8)
|
4.07 Score on a scale (100 points total)
Standard Deviation 10.92
|
4.83 Score on a scale (100 points total)
Standard Deviation 19.52
|
|
Change From Baseline in SF-36 (Average Physical Functioning) Total Score
Infusion 4 (Visit 5 - Week 12)
|
1.30 Score on a scale (100 points total)
Standard Deviation 9.16
|
4.31 Score on a scale (100 points total)
Standard Deviation 18.89
|
|
Change From Baseline in SF-36 (Average Physical Functioning) Total Score
Infusion 5 (Visit 6 - Week 16)
|
2.04 Score on a scale (100 points total)
Standard Deviation 13.61
|
6.03 Score on a scale (100 points total)
Standard Deviation 21.85
|
|
Change From Baseline in SF-36 (Average Physical Functioning) Total Score
Infusion 6 (Visit 7 - Week 20)
|
3.15 Score on a scale (100 points total)
Standard Deviation 8.68
|
6.03 Score on a scale (100 points total)
Standard Deviation 16.66
|
|
Change From Baseline in SF-36 (Average Physical Functioning) Total Score
End of Study (Visit 8 - Week 52)
|
1.82 Score on a scale (100 points total)
Standard Deviation 9.95
|
5.00 Score on a scale (100 points total)
Standard Deviation 22.49
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score
Infusion 2 (Visit 3 - Week 4)
|
0.44 Score on a scale (100 points total)
Standard Deviation 7.47
|
4.28 Score on a scale (100 points total)
Standard Deviation 10.14
|
|
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score
Infusion 3 (Visit 4 - Week 8)
|
1.63 Score on a scale (100 points total)
Standard Deviation 10.83
|
3.72 Score on a scale (100 points total)
Standard Deviation 12.51
|
|
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score
Infusion 4 (Visit 5 - Week 12)
|
2.67 Score on a scale (100 points total)
Standard Deviation 10.41
|
3.03 Score on a scale (100 points total)
Standard Deviation 15.11
|
|
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score
Infusion 5 (Visit 6 - Week 16)
|
0.15 Score on a scale (100 points total)
Standard Deviation 10.32
|
3.45 Score on a scale (100 points total)
Standard Deviation 14.65
|
|
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score
Infusion 6 (Visit 7 - Week 20)
|
0.00 Score on a scale (100 points total)
Standard Deviation 7.36
|
4.97 Score on a scale (100 points total)
Standard Deviation 15.41
|
|
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score
End of Study (Visit 8 - Week 52)
|
3.27 Score on a scale (100 points total)
Standard Deviation 8.25
|
3.26 Score on a scale (100 points total)
Standard Deviation 11.21
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in SF-36 (Average Social Functioning) Total Score
Infusion 2 (Visit 3 - Week 4)
|
0.00 Score on a scale (100 points total)
Standard Deviation 9.81
|
2.16 Score on a scale (100 points total)
Standard Deviation 10.06
|
|
Change From Baseline in SF-36 (Average Social Functioning) Total Score
Infusion 3 (Visit 4 - Week 8)
|
-1.39 Score on a scale (100 points total)
Standard Deviation 10.01
|
3.88 Score on a scale (100 points total)
Standard Deviation 13.82
|
|
Change From Baseline in SF-36 (Average Social Functioning) Total Score
Infusion 4 (Visit 5 - Week 12)
|
1.85 Score on a scale (100 points total)
Standard Deviation 13.29
|
1.72 Score on a scale (100 points total)
Standard Deviation 11.44
|
|
Change From Baseline in SF-36 (Average Social Functioning) Total Score
Infusion 5 (Visit 6 - Week 16)
|
2.31 Score on a scale (100 points total)
Standard Deviation 18.68
|
3.88 Score on a scale (100 points total)
Standard Deviation 14.98
|
|
Change From Baseline in SF-36 (Average Social Functioning) Total Score
Infusion 6 (Visit 7 - Week 20)
|
-0.46 Score on a scale (100 points total)
Standard Deviation 13.64
|
5.17 Score on a scale (100 points total)
Standard Deviation 17.20
|
|
Change From Baseline in SF-36 (Average Social Functioning) Total Score
End of Study (Visit 8 - Week 52)
|
-3.98 Score on a scale (100 points total)
Standard Deviation 17.42
|
2.78 Score on a scale (100 points total)
Standard Deviation 20.31
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score
Infusion 5 (Visit 6 - Week 16)
|
0.19 Score on a scale (100 points total)
Standard Deviation 13.83
|
5.34 Score on a scale (100 points total)
Standard Deviation 15.86
|
|
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score
Infusion 6 (Visit 7 - Week 20)
|
5.00 Score on a scale (100 points total)
Standard Deviation 14.68
|
7.07 Score on a scale (100 points total)
Standard Deviation 18.97
|
|
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score
End of Study (Visit 8 - Week 52)
|
3.18 Score on a scale (100 points total)
Standard Deviation 12.40
|
7.59 Score on a scale (100 points total)
Standard Deviation 24.23
|
|
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score
Infusion 2 (Visit 3 - Week 4)
|
2.41 Score on a scale (100 points total)
Standard Deviation 7.77
|
3.62 Score on a scale (100 points total)
Standard Deviation 16.31
|
|
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score
Infusion 3 (Visit 4 - Week 8)
|
0.56 Score on a scale (100 points total)
Standard Deviation 9.64
|
3.79 Score on a scale (100 points total)
Standard Deviation 17.25
|
|
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score
Infusion 4 (Visit 5 - Week 12)
|
5.19 Score on a scale (100 points total)
Standard Deviation 11.05
|
5.34 Score on a scale (100 points total)
Standard Deviation 15.52
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score
Infusion 2 (Visit 3 - Week 4)
|
-1.57 Score on a scale (100 points total)
Standard Deviation 15.38
|
1.55 Score on a scale (100 points total)
Standard Deviation 14.54
|
|
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score
Infusion 3 (Visit 4 - Week 8)
|
0.37 Score on a scale (100 points total)
Standard Deviation 15.56
|
3.36 Score on a scale (100 points total)
Standard Deviation 21.07
|
|
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score
Infusion 4 (Visit 5 - Week 12)
|
3.15 Score on a scale (100 points total)
Standard Deviation 16.14
|
5.43 Score on a scale (100 points total)
Standard Deviation 16.66
|
|
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score
Infusion 5 (Visit 6 - Week 16)
|
3.61 Score on a scale (100 points total)
Standard Deviation 17.87
|
6.03 Score on a scale (100 points total)
Standard Deviation 18.35
|
|
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score
Infusion 6 (Visit 7 - Week 20)
|
4.26 Score on a scale (100 points total)
Standard Deviation 15.67
|
6.03 Score on a scale (100 points total)
Standard Deviation 15.30
|
|
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score
End of Study (Visit 8 - Week 52)
|
-2.73 Score on a scale (100 points total)
Standard Deviation 13.91
|
2.59 Score on a scale (100 points total)
Standard Deviation 22.97
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health) Total Score
Infusion 2 (Visit 3 - Week 4)
|
-1.85 Score on a scale (100 points total)
Standard Deviation 22.92
|
0.00 Score on a scale (100 points total)
Standard Deviation 34.07
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health) Total Score
Infusion 3 (Visit 4 - Week 8)
|
-0.93 Score on a scale (100 points total)
Standard Deviation 28.99
|
6.90 Score on a scale (100 points total)
Standard Deviation 42.20
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health) Total Score
Infusion 4 (Visit 5 - Week 12)
|
1.85 Score on a scale (100 points total)
Standard Deviation 39.79
|
-1.72 Score on a scale (100 points total)
Standard Deviation 34.02
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health) Total Score
Infusion 5 (Visit 6 - Week 16)
|
4.63 Score on a scale (100 points total)
Standard Deviation 33.99
|
12.07 Score on a scale (100 points total)
Standard Deviation 36.97
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health) Total Score
Infusion 6 (Visit 7 - Week 20)
|
-0.93 Score on a scale (100 points total)
Standard Deviation 32.88
|
3.45 Score on a scale (100 points total)
Standard Deviation 36.43
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health) Total Score
End of Study (Visit 8 - Week 52)
|
12.50 Score on a scale (100 points total)
Standard Deviation 30.62
|
-0.93 Score on a scale (100 points total)
Standard Deviation 40.12
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score
Infusion 2 (Visit 3 - Week 4)
|
6.17 Score on a scale (100 points total)
Standard Deviation 35.85
|
3.45 Score on a scale (100 points total)
Standard Deviation 47.43
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score
Infusion 3 (Visit 4 - Week 8)
|
14.81 Score on a scale (100 points total)
Standard Deviation 31.12
|
0.00 Score on a scale (100 points total)
Standard Deviation 51.18
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score
Infusion 4 (Visit 5 - Week 12)
|
3.70 Score on a scale (100 points total)
Standard Deviation 43.69
|
-2.30 Score on a scale (100 points total)
Standard Deviation 46.23
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score
Infusion 5 (Visit 6 - Week 16)
|
7.41 Score on a scale (100 points total)
Standard Deviation 38.49
|
-2.30 Score on a scale (100 points total)
Standard Deviation 45.37
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score
Infusion 6 (Visit 7 - Week 20)
|
1.23 Score on a scale (100 points total)
Standard Deviation 35.18
|
2.30 Score on a scale (100 points total)
Standard Deviation 53.40
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score
End of Study (Visit 8 - Week 52)
|
6.06 Score on a scale (100 points total)
Standard Deviation 31.93
|
2.47 Score on a scale (100 points total)
Standard Deviation 59.14
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in SF-36 (Average General Health) Total Score (Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
-2.949 Score on a scale (100 points total)
Standard Error 2.363
|
2.736 Score on a scale (100 points total)
Standard Error 2.363
|
|
Change From Baseline in SF-36 (Average General Health) Total Score (Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
-0.866 Score on a scale (100 points total)
Standard Error 2.189
|
0.861 Score on a scale (100 points total)
Standard Error 2.190
|
|
Change From Baseline in SF-36 (Average General Health) Total Score (Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
-2.949 Score on a scale (100 points total)
Standard Error 2.475
|
-1.639 Score on a scale (100 points total)
Standard Error 2.476
|
|
Change From Baseline in SF-36 (Average General Health) Total Score (Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
-4.408 Score on a scale (100 points total)
Standard Error 2.553
|
0.236 Score on a scale (100 points total)
Standard Error 2.553
|
|
Change From Baseline in SF-36 (Average General Health) Total Score (Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
-6.074 Score on a scale (100 points total)
Standard Error 2.404
|
0.445 Score on a scale (100 points total)
Standard Error 2.404
|
|
Change From Baseline in SF-36 (Average General Health) Total Score (Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
-0.225 Score on a scale (100 points total)
Standard Error 1.931
|
0.953 Score on a scale (100 points total)
Standard Error 1.759
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
1.022 Score on a scale (100 points total)
Standard Error 2.159
|
6.846 Score on a scale (100 points total)
Standard Error 2.160
|
|
Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
3.105 Score on a scale (100 points total)
Standard Error 2.825
|
5.179 Score on a scale (100 points total)
Standard Error 2.825
|
|
Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
-0.228 Score on a scale (100 points total)
Standard Error 2.687
|
4.971 Score on a scale (100 points total)
Standard Error 2.688
|
|
Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
0.397 Score on a scale (100 points total)
Standard Error 3.444
|
6.638 Score on a scale (100 points total)
Standard Error 3.444
|
|
Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
1.855 Score on a scale (100 points total)
Standard Error 2.254
|
6.846 Score on a scale (100 points total)
Standard Error 2.254
|
|
Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
-1.166 Score on a scale (100 points total)
Standard Error 3.562
|
4.816 Score on a scale (100 points total)
Standard Error 3.298
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
-0.196 Score on a scale (100 points total)
Standard Error 1.798
|
4.384 Score on a scale (100 points total)
Standard Error 1.798
|
|
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
1.971 Score on a scale (100 points total)
Standard Error 2.487
|
2.884 Score on a scale (100 points total)
Standard Error 2.487
|
|
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
2.637 Score on a scale (100 points total)
Standard Error 2.435
|
3.050 Score on a scale (100 points total)
Standard Error 2.435
|
|
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
0.471 Score on a scale (100 points total)
Standard Error 2.603
|
3.384 Score on a scale (100 points total)
Standard Error 2.603
|
|
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
0.137 Score on a scale (100 points total)
Standard Error 2.458
|
5.217 Score on a scale (100 points total)
Standard Error 2.459
|
|
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
3.827 Score on a scale (100 points total)
Standard Error 2.237
|
2.716 Score on a scale (100 points total)
Standard Error 2.063
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in SF-36 (Average Social Functioning) Total Score (Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
-0.846 Score on a scale (100 points total)
Standard Error 2.039
|
2.409 Score on a scale (100 points total)
Standard Error 2.039
|
|
Change From Baseline in SF-36 (Average Social Functioning) Total Score (Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
-2.409 Score on a scale (100 points total)
Standard Error 2.268
|
2.930 Score on a scale (100 points total)
Standard Error 2.269
|
|
Change From Baseline in SF-36 (Average Social Functioning) Total Score (Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
0.716 Score on a scale (100 points total)
Standard Error 2.435
|
0.326 Score on a scale (100 points total)
Standard Error 2.435
|
|
Change From Baseline in SF-36 (Average Social Functioning) Total Score (Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
2.279 Score on a scale (100 points total)
Standard Error 3.343
|
2.930 Score on a scale (100 points total)
Standard Error 3.343
|
|
Change From Baseline in SF-36 (Average Social Functioning) Total Score (Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
-1.367 Score on a scale (100 points total)
Standard Error 2.994
|
6.055 Score on a scale (100 points total)
Standard Error 2.994
|
|
Change From Baseline in SF-36 (Average Social Functioning) Total Score (Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
-3.700 Score on a scale (100 points total)
Standard Error 4.053
|
2.637 Score on a scale (100 points total)
Standard Error 3.760
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
0.162 Score on a scale (100 points total)
Standard Error 2.335
|
4.656 Score on a scale (100 points total)
Standard Error 2.335
|
|
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
-0.255 Score on a scale (100 points total)
Standard Error 2.814
|
3.823 Score on a scale (100 points total)
Standard Error 2.814
|
|
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
2.662 Score on a scale (100 points total)
Standard Error 2.448
|
5.281 Score on a scale (100 points total)
Standard Error 2.448
|
|
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
-1.713 Score on a scale (100 points total)
Standard Error 3.052
|
6.323 Score on a scale (100 points total)
Standard Error 3.052
|
|
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
3.078 Score on a scale (100 points total)
Standard Error 3.107
|
8.615 Score on a scale (100 points total)
Standard Error 3.107
|
|
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
2.802 Score on a scale (100 points total)
Standard Error 4.008
|
8.943 Score on a scale (100 points total)
Standard Error 3.815
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
-1.331 Score on a scale (100 points total)
Standard Error 2.920
|
1.592 Score on a scale (100 points total)
Standard Error 2.919
|
|
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
0.857 Score on a scale (100 points total)
Standard Error 3.043
|
2.842 Score on a scale (100 points total)
Standard Error 3.041
|
|
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
1.586 Score on a scale (100 points total)
Standard Error 3.074
|
4.926 Score on a scale (100 points total)
Standard Error 3.072
|
|
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
2.107 Score on a scale (100 points total)
Standard Error 3.149
|
4.717 Score on a scale (100 points total)
Standard Error 3.148
|
|
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
3.774 Score on a scale (100 points total)
Standard Error 3.024
|
6.697 Score on a scale (100 points total)
Standard Error 3.023
|
|
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
-1.010 Score on a scale (100 points total)
Standard Error 4.191
|
1.644 Score on a scale (100 points total)
Standard Error 3.905
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health ) Total Score (Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
-4.925 Score on a scale (100 points total)
Standard Error 5.460
|
0.165 Score on a scale (100 points total)
Standard Error 5.462
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health ) Total Score (Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
-1.800 Score on a scale (100 points total)
Standard Error 6.582
|
9.540 Score on a scale (100 points total)
Standard Error 6.584
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health ) Total Score (Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
-1.800 Score on a scale (100 points total)
Standard Error 6.430
|
-0.876 Score on a scale (100 points total)
Standard Error 6.432
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health ) Total Score (Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
1.325 Score on a scale (100 points total)
Standard Error 6.414
|
15.790 Score on a scale (100 points total)
Standard Error 6.416
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health ) Total Score (Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
-1.800 Score on a scale (100 points total)
Standard Error 6.788
|
8.499 Score on a scale (100 points total)
Standard Error 6.790
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Physical Health ) Total Score (Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
9.086 Score on a scale (100 points total)
Standard Error 7.559
|
0.602 Score on a scale (100 points total)
Standard Error 6.883
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score (Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
4.143 Score on a scale (100 points total)
Standard Error 7.238
|
1.724 Score on a scale (100 points total)
Standard Error 7.239
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score (Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
13.865 Score on a scale (100 points total)
Standard Error 7.435
|
-3.832 Score on a scale (100 points total)
Standard Error 7.437
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score (Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
2.754 Score on a scale (100 points total)
Standard Error 7.892
|
-6.610 Score on a scale (100 points total)
Standard Error 7.893
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score (Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
4.143 Score on a scale (100 points total)
Standard Error 7.341
|
0.335 Score on a scale (100 points total)
Standard Error 7.343
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score (Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
-1.413 Score on a scale (100 points total)
Standard Error 7.613
|
5.890 Score on a scale (100 points total)
Standard Error 7.615
|
|
Change From Baseline in SF-36 (Average Role Limitations Due to Emotional Problems) Total Score (Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
5.561 Score on a scale (100 points total)
Standard Error 9.054
|
-0.517 Score on a scale (100 points total)
Standard Error 8.173
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in SF-36 (Average General Health) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
-0.068 Score on a scale (100 points total)
Standard Deviation 2.221
|
3.570 Score on a scale (100 points total)
Standard Deviation 2.348
|
|
Change From Baseline in SF-36 (Average General Health) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
0.986 Score on a scale (100 points total)
Standard Deviation 2.110
|
2.279 Score on a scale (100 points total)
Standard Deviation 2.188
|
|
Change From Baseline in SF-36 (Average General Health) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
1.518 Score on a scale (100 points total)
Standard Deviation 2.206
|
1.769 Score on a scale (100 points total)
Standard Deviation 2.345
|
|
Change From Baseline in SF-36 (Average General Health) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
0.459 Score on a scale (100 points total)
Standard Deviation 2.201
|
3.035 Score on a scale (100 points total)
Standard Deviation 2.372
|
|
Change From Baseline in SF-36 (Average General Health) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
-0.279 Score on a scale (100 points total)
Standard Deviation 2.153
|
3.837 Score on a scale (100 points total)
Standard Deviation 2.303
|
|
Change From Baseline in SF-36 (Average General Health) Total Score (Bayesian Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
0.617 Score on a scale (100 points total)
Standard Deviation 1.807
|
2.302 Score on a scale (100 points total)
Standard Deviation 1.856
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
0.400 Score on a scale (100 points total)
Standard Deviation 2.224
|
4.659 Score on a scale (100 points total)
Standard Deviation 2.526
|
|
Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
1.219 Score on a scale (100 points total)
Standard Deviation 2.443
|
2.941 Score on a scale (100 points total)
Standard Deviation 2.852
|
|
Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
0.370 Score on a scale (100 points total)
Standard Deviation 2.354
|
4.210 Score on a scale (100 points total)
Standard Deviation 2.783
|
|
Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
0.000 Score on a scale (100 points total)
Standard Deviation 2.684
|
3.983 Score on a scale (100 points total)
Standard Deviation 3.207
|
|
Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
0.662 Score on a scale (100 points total)
Standard Deviation 2.217
|
4.293 Score on a scale (100 points total)
Standard Deviation 2.536
|
|
Change From Baseline in SF-36 (Average Physical Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
-0.156 Score on a scale (100 points total)
Standard Deviation 2.041
|
2.937 Score on a scale (100 points total)
Standard Deviation 2.522
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
0.801 Score on a scale (100 points total)
Standard Deviation 2.127
|
4.494 Score on a scale (100 points total)
Standard Deviation 2.428
|
|
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
1.564 Score on a scale (100 points total)
Standard Deviation 2.385
|
3.032 Score on a scale (100 points total)
Standard Deviation 2.781
|
|
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
1.937 Score on a scale (100 points total)
Standard Deviation 2.332
|
2.588 Score on a scale (100 points total)
Standard Deviation 2.774
|
|
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
1.058 Score on a scale (100 points total)
Standard Deviation 2.395
|
3.514 Score on a scale (100 points total)
Standard Deviation 2.865
|
|
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
0.657 Score on a scale (100 points total)
Standard Deviation 2.400
|
4.344 Score on a scale (100 points total)
Standard Deviation 2.811
|
|
Change From Baseline in SF-36 Mental Health Domain (Average Emotional Well-Being) Total Score (Bayesian Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
1.214 Score on a scale (100 points total)
Standard Deviation 1.970
|
2.838 Score on a scale (100 points total)
Standard Deviation 2.364
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in SF-36 (Average Social Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
2.025 Score on a scale (100 points total)
Standard Deviation 2.595
|
4.902 Score on a scale (100 points total)
Standard Deviation 2.844
|
|
Change From Baseline in SF-36 (Average Social Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
1.562 Score on a scale (100 points total)
Standard Deviation 2.580
|
5.031 Score on a scale (100 points total)
Standard Deviation 2.905
|
|
Change From Baseline in SF-36 (Average Social Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
2.720 Score on a scale (100 points total)
Standard Deviation 2.637
|
3.561 Score on a scale (100 points total)
Standard Deviation 3.021
|
|
Change From Baseline in SF-36 (Average Social Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
2.265 Score on a scale (100 points total)
Standard Deviation 2.914
|
3.583 Score on a scale (100 points total)
Standard Deviation 3.502
|
|
Change From Baseline in SF-36 (Average Social Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
0.908 Score on a scale (100 points total)
Standard Deviation 2.791
|
5.513 Score on a scale (100 points total)
Standard Deviation 3.321
|
|
Change From Baseline in SF-36 (Average Social Functioning) Total Score (Bayesian Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
1.456 Score on a scale (100 points total)
Standard Deviation 2.272
|
4.015 Score on a scale (100 points total)
Standard Deviation 2.820
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
0.002 Score on a scale (100 points total)
Standard Deviation 2.251
|
2.735 Score on a scale (100 points total)
Standard Deviation 2.562
|
|
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
0.146 Score on a scale (100 points total)
Standard Deviation 2.436
|
2.413 Score on a scale (100 points total)
Standard Deviation 2.860
|
|
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
0.713 Score on a scale (100 points total)
Standard Deviation 2.301
|
2.026 Score on a scale (100 points total)
Standard Deviation 2.656
|
|
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
-0.932 Score on a scale (100 points total)
Standard Deviation 2.493
|
3.583 Score on a scale (100 points total)
Standard Deviation 2.954
|
|
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
-0.298 Score on a scale (100 points total)
Standard Deviation 2.416
|
2.285 Score on a scale (100 points total)
Standard Deviation 2.853
|
|
Change From Baseline in SF-36 Vitality Domain (Average Energy/Fatigue) Total Score (Bayesian Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
-0.222 Score on a scale (100 points total)
Standard Deviation 2.090
|
2.332 Score on a scale (100 points total)
Standard Deviation 2.622
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
-1.027 Score on a scale (100 points total)
Standard Deviation 2.519
|
1.526 Score on a scale (100 points total)
Standard Deviation 2.876
|
|
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
-1.257 Score on a scale (100 points total)
Standard Deviation 2.653
|
0.813 Score on a scale (100 points total)
Standard Deviation 3.161
|
|
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
-1.311 Score on a scale (100 points total)
Standard Deviation 2.604
|
1.500 Score on a scale (100 points total)
Standard Deviation 3.071
|
|
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
-1.415 Score on a scale (100 points total)
Standard Deviation 2.619
|
0.885 Score on a scale (100 points total)
Standard Deviation 3.138
|
|
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
-1.350 Score on a scale (100 points total)
Standard Deviation 2.522
|
1.216 Score on a scale (100 points total)
Standard Deviation 2.913
|
|
Change From Baseline in SF-36 Bodily Pain Domain (Average Pain) Total Score (Bayesian Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
-1.725 Score on a scale (100 points total)
Standard Deviation 2.237
|
0.607 Score on a scale (100 points total)
Standard Deviation 2.660
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in SF-36 (Average Role Limitations Due To Physical Health) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
5.279 Score on a scale (100 points total)
Standard Deviation 3.419
|
8.530 Score on a scale (100 points total)
Standard Deviation 4.519
|
|
Change From Baseline in SF-36 (Average Role Limitations Due To Physical Health) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
4.459 Score on a scale (100 points total)
Standard Deviation 3.651
|
8.652 Score on a scale (100 points total)
Standard Deviation 4.922
|
|
Change From Baseline in SF-36 (Average Role Limitations Due To Physical Health) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
4.947 Score on a scale (100 points total)
Standard Deviation 3.574
|
6.531 Score on a scale (100 points total)
Standard Deviation 4.820
|
|
Change From Baseline in SF-36 (Average Role Limitations Due To Physical Health) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
4.448 Score on a scale (100 points total)
Standard Deviation 3.591
|
8.840 Score on a scale (100 points total)
Standard Deviation 4.804
|
|
Change From Baseline in SF-36 (Average Role Limitations Due To Physical Health) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
4.589 Score on a scale (100 points total)
Standard Deviation 3.547
|
8.886 Score on a scale (100 points total)
Standard Deviation 4.764
|
|
Change From Baseline in SF-36 (Average Role Limitations Due To Physical Health) Total Score (Bayesian Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
3.980 Score on a scale (100 points total)
Standard Deviation 2.690
|
6.603 Score on a scale (100 points total)
Standard Deviation 3.668
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The SF-36 Health Survey is a patient-reported assessment that measures health-related quality of life across eight domains, including physical functioning, bodily pain, general health, vitality, social functioning, role limitations (physical and emotional), and mental health. Each of the eight domains is scored separately and transformed to a 0-100 scale, with higher scores indicating better health status. The domains and their score ranges are: Physical Functioning (PF): 0-100 Role Limitations due to Physical Health (RP): 0-100 Bodily Pain (BP): 0-100 General Health (GH): 0-100 Vitality (VT): 0-100 Social Functioning (SF): 0-100 Role Limitations due to Emotional Problems (RE): 0-100 Mental Health (MH): 0-100 Each domain score is calculated by summing and transforming item responses within that domain. In addition to these, two summary scores-the Physical Component Summary (PCS) and Mental Component Summary (MCS)-are derived using standardized scoring methods.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in SF-36 (Average Role Limitations Due To Emotional Problems) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
-3.296 Score on a scale (100 points total)
Standard Deviation 3.632
|
-1.252 Score on a scale (100 points total)
Standard Deviation 4.576
|
|
Change From Baseline in SF-36 (Average Role Limitations Due To Emotional Problems) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
-2.304 Score on a scale (100 points total)
Standard Deviation 3.713
|
-1.581 Score on a scale (100 points total)
Standard Deviation 4.771
|
|
Change From Baseline in SF-36 (Average Role Limitations Due To Emotional Problems) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
-3.108 Score on a scale (100 points total)
Standard Deviation 3.848
|
-2.125 Score on a scale (100 points total)
Standard Deviation 4.946
|
|
Change From Baseline in SF-36 (Average Role Limitations Due To Emotional Problems) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
-3.509 Score on a scale (100 points total)
Standard Deviation 3.692
|
-1.868 Score on a scale (100 points total)
Standard Deviation 4.682
|
|
Change From Baseline in SF-36 (Average Role Limitations Due To Emotional Problems) Total Score (Bayesian Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
-2.634 Score on a scale (100 points total)
Standard Deviation 3.646
|
0.209 Score on a scale (100 points total)
Standard Deviation 4.691
|
|
Change From Baseline in SF-36 (Average Role Limitations Due To Emotional Problems) Total Score (Bayesian Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
-3.844 Score on a scale (100 points total)
Standard Deviation 2.899
|
-2.455 Score on a scale (100 points total)
Standard Deviation 3.642
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients. It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function. It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect. There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points). The PFS-16 score ranges from 16 (minimum) to 80 (maximum). Higher scores represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Raw Scores
Infusion 2 (Visit 3 - Week 4)
|
-0.89 Score on a scale (80 points total)
Standard Deviation 7.33
|
-1.48 Score on a scale (80 points total)
Standard Deviation 7.51
|
|
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Raw Scores
Infusion 3 (Visit 4 - Week 8)
|
-0.33 Score on a scale (80 points total)
Standard Deviation 7.89
|
-1.59 Score on a scale (80 points total)
Standard Deviation 9.15
|
|
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Raw Scores
Infusion 4 (Visit 5 - Week 12)
|
-1.89 Score on a scale (80 points total)
Standard Deviation 9.56
|
-3.00 Score on a scale (80 points total)
Standard Deviation 11.27
|
|
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Raw Scores
Infusion 5 (Visit 6 - Week 16)
|
-2.44 Score on a scale (80 points total)
Standard Deviation 9.35
|
-3.34 Score on a scale (80 points total)
Standard Deviation 12.25
|
|
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Raw Scores
Infusion 6 (Visit 7 - Week 20)
|
-0.52 Score on a scale (80 points total)
Standard Deviation 8.90
|
-5.79 Score on a scale (80 points total)
Standard Deviation 13.52
|
|
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Raw Scores
End of Study (Visit 8 - Week 52)
|
-3.05 Score on a scale (80 points total)
Standard Deviation 8.19
|
-7.78 Score on a scale (80 points total)
Standard Deviation 16.20
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Clinically significant changes in PFS-16 scores. The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients. It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function. It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect. There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points). The PFS-16 score ranges from 16 (minimum) to 80 (maximum). Higher scores represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
0.342 Score on a scale (80 points total)
Standard Error 1.367
|
-1.610 Score on a scale (80 points total)
Standard Error 1.367
|
|
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
0.217 Score on a scale (80 points total)
Standard Error 1.719
|
-1.318 Score on a scale (80 points total)
Standard Error 1.720
|
|
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
-0.575 Score on a scale (80 points total)
Standard Error 2.172
|
-2.443 Score on a scale (80 points total)
Standard Error 2.173
|
|
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
-1.492 Score on a scale (80 points total)
Standard Error 2.220
|
-3.693 Score on a scale (80 points total)
Standard Error 2.220
|
|
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
0.342 Score on a scale (80 points total)
Standard Error 2.272
|
-7.401 Score on a scale (80 points total)
Standard Error 2.272
|
|
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
-3.118 Score on a scale (80 points total)
Standard Error 2.861
|
-7.153 Score on a scale (80 points total)
Standard Error 2.752
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Clinically significant changes in PFS-16 scores. The Parkinson's Disease Fatigue Scale (PFS-16) is a patient-rated scale that measures fatigue in Parkinson's patients. It has 7 items on the measurement of presence of fatigue and 9 items on its impact on daily function. It can be used to assess levels of fatigue and measure any changes that treatment or lifestyle changes may affect. There are five answer choices for each item: Strongly disagree (1 point), Disagree (2 points), Do not agree or disagree (3 points), Agree (4 points), and Strongly agree (5 points). The PFS-16 score ranges from 16 (minimum) to 80 (maximum). Higher scores represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Bayesian Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
0.934 Score on a scale (80 points total)
Standard Deviation 2.100
|
-0.358 Score on a scale (80 points total)
Standard Deviation 2.312
|
|
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Bayesian Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
1.567 Score on a scale (80 points total)
Standard Deviation 1.776
|
0.255 Score on a scale (80 points total)
Standard Deviation 1.720
|
|
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Bayesian Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
1.046 Score on a scale (80 points total)
Standard Deviation 2.001
|
0.523 Score on a scale (80 points total)
Standard Deviation 1.976
|
|
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Bayesian Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
0.909 Score on a scale (80 points total)
Standard Deviation 2.184
|
0.547 Score on a scale (80 points total)
Standard Deviation 2.231
|
|
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Bayesian Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
0.962 Score on a scale (80 points total)
Standard Deviation 2.233
|
0.448 Score on a scale (80 points total)
Standard Deviation 2.304
|
|
Change From Baseline in Parkinson's Disease Fatigue Scale (PFS-16) Score (Bayesian Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
2.697 Score on a scale (80 points total)
Standard Deviation 2.212
|
-1.587 Score on a scale (80 points total)
Standard Deviation 2.330
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Clinically significant changes in PDQ-39 SI raw scores. The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month. The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being. Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always). The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100). To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100). Higher scores represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores
Infusion 2 (Visit 3 - Week 4)
|
-1.31 Score on a scale (100 points total)
Standard Deviation 5.30
|
-2.25 Score on a scale (100 points total)
Standard Deviation 6.60
|
|
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores
Infusion 3 (Visit 4 - Week 8)
|
-2.54 Score on a scale (100 points total)
Standard Deviation 5.74
|
-3.18 Score on a scale (100 points total)
Standard Deviation 6.51
|
|
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores
Infusion 4 (Visit 5 - Week 12)
|
-2.67 Score on a scale (100 points total)
Standard Deviation 5.96
|
-3.16 Score on a scale (100 points total)
Standard Deviation 6.91
|
|
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores
Infusion 5 (Visit 6 - Week 16)
|
-3.66 Score on a scale (100 points total)
Standard Deviation 5.82
|
-3.53 Score on a scale (100 points total)
Standard Deviation 9.18
|
|
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores
Infusion 6 (Visit 7 - Week 20)
|
-2.78 Score on a scale (100 points total)
Standard Deviation 6.47
|
-4.23 Score on a scale (100 points total)
Standard Deviation 9.74
|
|
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores
End of Study (Visit 8 - Week 52)
|
0.41 Score on a scale (100 points total)
Standard Deviation 8.34
|
-3.07 Score on a scale (100 points total)
Standard Deviation 10.03
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Clinically significant changes in PDQ-39 SI raw scores. The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month. The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being. Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always). The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100). To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100). Higher scores represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
-0.985 Score on a scale (100 points total)
Standard Error 1.153
|
-2.853 Score on a scale (100 points total)
Standard Error 1.154
|
|
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
-2.510 Score on a scale (100 points total)
Standard Error 1.238
|
-3.186 Score on a scale (100 points total)
Standard Error 1.238
|
|
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
-2.375 Score on a scale (100 points total)
Standard Error 1.355
|
-3.166 Score on a scale (100 points total)
Standard Error 1.356
|
|
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
-3.333 Score on a scale (100 points total)
Standard Error 1.464
|
-3.801 Score on a scale (100 points total)
Standard Error 1.464
|
|
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
-2.729 Score on a scale (100 points total)
Standard Error 1.529
|
-5.243 Score on a scale (100 points total)
Standard Error 1.529
|
|
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
0.254 Score on a scale (100 points total)
Standard Error 2.023
|
-3.107 Score on a scale (100 points total)
Standard Error 1.883
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Clinically significant changes in PDQ-39 SI raw scores. The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month. The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being. Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always). The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100). To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100). Higher scores represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Bayesian Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
-2.909 Score on a scale (100 points total)
Standard Deviation 2.949
|
-4.060 Score on a scale (100 points total)
Standard Deviation 2.888
|
|
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Bayesian Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
-3.313 Score on a scale (100 points total)
Standard Deviation 3.013
|
-3.633 Score on a scale (100 points total)
Standard Deviation 2.906
|
|
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Bayesian Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
-3.342 Score on a scale (100 points total)
Standard Deviation 3.052
|
-3.609 Score on a scale (100 points total)
Standard Deviation 2.949
|
|
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Bayesian Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
-3.648 Score on a scale (100 points total)
Standard Deviation 3.069
|
-3.372 Score on a scale (100 points total)
Standard Deviation 2.997
|
|
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Bayesian Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
-2.626 Score on a scale (100 points total)
Standard Deviation 3.096
|
-4.392 Score on a scale (100 points total)
Standard Deviation 3.013
|
|
Change From Baseline in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores (Bayesian Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
-3.559 Score on a scale (100 points total)
Standard Deviation 3.045
|
-4.535 Score on a scale (100 points total)
Standard Deviation 3.047
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The Parkinson's Disease Questionnaire, or PDQ-39, is a 39-item self-report questionnaire which assesses Parkinson's disease-specific health related quality of life over the last month. The assessment looks at how often patient experience difficulties across the 8 quality of life dimensions (Mobility, Activities of Daily Living, Emotional well-being, Stigma, Social support, Cognition, Communication, and Bodily discomfort) and assesses the impact of Parkinson's disease on specific dimensions of functioning and well-being. Each item is scored with one of the following selections: 0 (Never), 25 (Occasionally), 50 (Sometimes), 75 (Often), and 100 (Always). The answers to the items for each dimension are averaged to calculate a dimension score (minimum of 0 and maximum of 100). To calculate the Summary Index, all 8 dimension scores are averaged (minimum of 0 and maximum of 100). Higher scores represent a worse outcome.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores - by Treatment Week
Infusion 2 (Visit 3 - Week 4) · Yes
|
7 Participants
|
12 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores - by Treatment Week
Infusion 2 (Visit 3 - Week 4) · No
|
20 Participants
|
17 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores - by Treatment Week
Infusion 3 (Visit 4 - Week 8) · Yes
|
8 Participants
|
12 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores - by Treatment Week
Infusion 3 (Visit 4 - Week 8) · No
|
19 Participants
|
17 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores - by Treatment Week
Infusion 4 (Visit 5 - Week 12) · Yes
|
10 Participants
|
14 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores - by Treatment Week
Infusion 4 (Visit 5 - Week 12) · No
|
17 Participants
|
15 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores - by Treatment Week
Infusion 5 (Visit 6 - Week 16) · Yes
|
11 Participants
|
13 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores - by Treatment Week
Infusion 5 (Visit 6 - Week 16) · No
|
16 Participants
|
16 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores - by Treatment Week
Infusion 6 (Visit 7 - Week 20) · Yes
|
11 Participants
|
15 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores - by Treatment Week
Infusion 6 (Visit 7 - Week 20) · No
|
16 Participants
|
14 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores - by Treatment Week
End of Study (Visit 8 - Week 52) · Yes
|
5 Participants
|
10 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Parkinson's Disease Questionnaire (PDQ-39) Summary Index (SI) Raw Scores - by Treatment Week
End of Study (Visit 8 - Week 52) · No
|
17 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Clinically significant changes in VAS Pain raw scores. The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas. The patient marks a point on the line corresponding to their pain intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm. Higher scores represent worse outcomes.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in Visual Analog Scale (VAS) Pain Raw Scores
Infusion 4 (Visit 5 - Week 12)
|
-0.48 Score on a scale (10 points total)
Standard Deviation 1.79
|
-0.37 Score on a scale (10 points total)
Standard Deviation 1.84
|
|
Change From Baseline in Visual Analog Scale (VAS) Pain Raw Scores
Infusion 2 (Visit 3 - Week 4)
|
-0.00 Score on a scale (10 points total)
Standard Deviation 1.59
|
-0.14 Score on a scale (10 points total)
Standard Deviation 1.70
|
|
Change From Baseline in Visual Analog Scale (VAS) Pain Raw Scores
Infusion 3 (Visit 4 - Week 8)
|
-0.23 Score on a scale (10 points total)
Standard Deviation 1.46
|
-0.15 Score on a scale (10 points total)
Standard Deviation 1.78
|
|
Change From Baseline in Visual Analog Scale (VAS) Pain Raw Scores
Infusion 5 (Visit 6 - Week 16)
|
-0.57 Score on a scale (10 points total)
Standard Deviation 1.72
|
0.35 Score on a scale (10 points total)
Standard Deviation 2.02
|
|
Change From Baseline in Visual Analog Scale (VAS) Pain Raw Scores
Infusion 6 (Visit 7 - Week 20)
|
-0.78 Score on a scale (10 points total)
Standard Deviation 1.71
|
-0.28 Score on a scale (10 points total)
Standard Deviation 1.22
|
|
Change From Baseline in Visual Analog Scale (VAS) Pain Raw Scores
End of Study (Visit 8 - Week 52)
|
0.01 Score on a scale (10 points total)
Standard Deviation 2.12
|
-0.21 Score on a scale (10 points total)
Standard Deviation 1.24
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Clinically significant changes in VAS Pain raw scores. The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas. The patient marks a point on the line corresponding to their pain intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm. Higher scores represent worse outcomes.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
-0.082 Score on a scale (10 points total)
Standard Error 0.294
|
-0.215 Score on a scale (10 points total)
Standard Error 0.294
|
|
Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
-0.271 Score on a scale (10 points total)
Standard Error 0.320
|
-0.101 Score on a scale (10 points total)
Standard Error 0.320
|
|
Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
-0.371 Score on a scale (10 points total)
Standard Error 0.330
|
-0.367 Score on a scale (10 points total)
Standard Error 0.330
|
|
Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
-0.457 Score on a scale (10 points total)
Standard Error 0.370
|
0.629 Score on a scale (10 points total)
Standard Error 0.371
|
|
Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
-0.723 Score on a scale (10 points total)
Standard Error 0.294
|
-0.301 Score on a scale (10 points total)
Standard Error 0.295
|
|
Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
0.322 Score on a scale (10 points total)
Standard Error 0.376
|
-0.310 Score on a scale (10 points total)
Standard Error 0.357
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Clinically significant changes in VAS Pain raw scores. The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" used to measure intensity in pain and various other areas. The patient marks a point on the line corresponding to their pain intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm. Higher scores represent worse outcomes.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Bayesian Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
-0.147 Score on a scale (10 points total)
Standard Deviation 0.406
|
-0.265 Score on a scale (10 points total)
Standard Deviation 0.379
|
|
Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Bayesian Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
-0.275 Score on a scale (10 points total)
Standard Deviation 0.427
|
-0.127 Score on a scale (10 points total)
Standard Deviation 0.397
|
|
Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Bayesian Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
-0.227 Score on a scale (10 points total)
Standard Deviation 0.427
|
-0.190 Score on a scale (10 points total)
Standard Deviation 0.413
|
|
Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Bayesian Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
-0.732 Score on a scale (10 points total)
Standard Deviation 0.463
|
0.333 Score on a scale (10 points total)
Standard Deviation 0.448
|
|
Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Bayesian Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
-0.425 Score on a scale (10 points total)
Standard Deviation 0.406
|
0.020 Score on a scale (10 points total)
Standard Deviation 0.382
|
|
Change From Baseline in Visual Analog Scale (VAS) Pain Scores (Bayesian Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
0.069 Score on a scale (10 points total)
Standard Deviation 0.465
|
-0.456 Score on a scale (10 points total)
Standard Deviation 0.437
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Clinically significant changes in VAS Muscle Spasm raw scores. The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no muscle spasms" and "worst muscle spasms" used to measure intensity in muscle spasms and various other areas. The patient marks a point on the line corresponding to their muscle spasm intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm. Higher scores represent worse outcomes.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Raw Scores
Infusion 2 (Visit 3 - Week 4)
|
-0.37 Score on a scale (10 points total)
Standard Deviation 1.99
|
-0.43 Score on a scale (10 points total)
Standard Deviation 1.54
|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Raw Scores
Infusion 3 (Visit 4 - Week 8)
|
-0.49 Score on a scale (10 points total)
Standard Deviation 1.85
|
-0.35 Score on a scale (10 points total)
Standard Deviation 2.04
|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Raw Scores
Infusion 4 (Visit 5 - Week 12)
|
-0.59 Score on a scale (10 points total)
Standard Deviation 2.15
|
-0.27 Score on a scale (10 points total)
Standard Deviation 1.40
|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Raw Scores
Infusion 5 (Visit 6 - Week 16)
|
-0.64 Score on a scale (10 points total)
Standard Deviation 2.31
|
-0.25 Score on a scale (10 points total)
Standard Deviation 2.29
|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Raw Scores
Infusion 6 (Visit 7 - Week 20)
|
-0.65 Score on a scale (10 points total)
Standard Deviation 2.38
|
-0.93 Score on a scale (10 points total)
Standard Deviation 2.13
|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Raw Scores
End of Study (Visit 8 - Week 52)
|
-0.54 Score on a scale (10 points total)
Standard Deviation 2.14
|
-0.89 Score on a scale (10 points total)
Standard Deviation 2.50
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Clinically significant changes in VAS Muscle Spasm raw scores. The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no muscle spasms" and "worst muscle spasms" used to measure intensity in muscle spasms and various other areas. The patient marks a point on the line corresponding to their muscle spasm intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm. Higher scores represent worse outcomes.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
-0.354 Score on a scale (10 points total)
Standard Error 0.318
|
-0.455 Score on a scale (10 points total)
Standard Error 0.318
|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
-0.482 Score on a scale (10 points total)
Standard Error 0.374
|
-0.248 Score on a scale (10 points total)
Standard Error 0.374
|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
-0.563 Score on a scale (10 points total)
Standard Error 0.361
|
-0.198 Score on a scale (10 points total)
Standard Error 0.361
|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
-0.605 Score on a scale (10 points total)
Standard Error 0.433
|
-0.105 Score on a scale (10 points total)
Standard Error 0.433
|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
-0.617 Score on a scale (10 points total)
Standard Error 0.380
|
-1.111 Score on a scale (10 points total)
Standard Error 0.380
|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
-0.387 Score on a scale (10 points total)
Standard Error 0.424
|
-0.810 Score on a scale (10 points total)
Standard Error 0.404
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. The efficacy analysis set analyzed in the objectives is described as the number of participants who completed all six infusions, which is 24 placebo participants and 24 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Clinically significant changes in VAS Muscle Spasm raw scores. The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no muscle spasms" and "worst muscle spasms" used to measure intensity in muscle spasms and various other areas. The patient marks a point on the line corresponding to their muscle spasm intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm. Higher scores represent worse outcomes.
Outcome measures
| Measure |
Placebo
n=24 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Bayesian Statistical Analysis - RMA Model)
Infusion 2 (Visit 3 - Week 4)
|
-0.770 Score on a scale (10 points total)
Standard Deviation 0.447
|
-0.883 Score on a scale (10 points total)
Standard Deviation 0.436
|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Bayesian Statistical Analysis - RMA Model)
Infusion 3 (Visit 4 - Week 8)
|
-0.946 Score on a scale (10 points total)
Standard Deviation 0.478
|
-0.708 Score on a scale (10 points total)
Standard Deviation 0.483
|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Bayesian Statistical Analysis - RMA Model)
Infusion 4 (Visit 5 - Week 12)
|
-0.993 Score on a scale (10 points total)
Standard Deviation 0.472
|
-0.652 Score on a scale (10 points total)
Standard Deviation 0.471
|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Bayesian Statistical Analysis - RMA Model)
Infusion 5 (Visit 6 - Week 16)
|
-1.083 Score on a scale (10 points total)
Standard Deviation 0.531
|
-0.575 Score on a scale (10 points total)
Standard Deviation 0.525
|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Bayesian Statistical Analysis - RMA Model)
Infusion 6 (Visit 7 - Week 20)
|
-0.599 Score on a scale (10 points total)
Standard Deviation 0.490
|
-1.061 Score on a scale (10 points total)
Standard Deviation 0.486
|
|
Change From Baseline in Visual Analog Scale (VAS) Muscle Spasm Scores (Bayesian Statistical Analysis - RMA Model)
End of Study (Visit 8 - Week 52)
|
-0.520 Score on a scale (10 points total)
Standard Deviation 0.518
|
-0.858 Score on a scale (10 points total)
Standard Deviation 0.496
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
The VAS is a validated, subjective measurement tool, typically a 10-cm line anchored by "no pain" and "worst imaginable pain" in the Pain section and "No muscle spasm" and "worst muscle spasm" in the Muscle Spasm section, used to measure intensity in pain and various other areas. The patient marks a point on the line corresponding to their pain intensity. The minimum score is read as 0 cm and the maximum score is read as 10 cm for each section. The total score is achieved by summing the two individual scores. Higher scores represent worse outcomes.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total VAS Scores - by Treatment Week
Infusion 2 (Visit 3 - Week 4) · Yes
|
7 Participants
|
6 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total VAS Scores - by Treatment Week
Infusion 2 (Visit 3 - Week 4) · No
|
20 Participants
|
23 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total VAS Scores - by Treatment Week
Infusion 3 (Visit 4 - Week 8) · Yes
|
7 Participants
|
7 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total VAS Scores - by Treatment Week
Infusion 3 (Visit 4 - Week 8) · No
|
20 Participants
|
22 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total VAS Scores - by Treatment Week
Infusion 4 (Visit 5 - Week 12) · Yes
|
9 Participants
|
7 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total VAS Scores - by Treatment Week
Infusion 4 (Visit 5 - Week 12) · No
|
18 Participants
|
22 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total VAS Scores - by Treatment Week
Infusion 5 (Visit 6 - Week 16) · Yes
|
8 Participants
|
6 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total VAS Scores - by Treatment Week
Infusion 5 (Visit 6 - Week 16) · No
|
19 Participants
|
23 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total VAS Scores - by Treatment Week
Infusion 6 (Visit 7 - Week 20) · Yes
|
11 Participants
|
8 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total VAS Scores - by Treatment Week
Infusion 6 (Visit 7 - Week 20) · No
|
16 Participants
|
21 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total VAS Scores - by Treatment Week
End of Study (Visit 8 - Week 52) · Yes
|
5 Participants
|
6 Participants
|
|
Subjects Achieving an Improvement (Reduction) in Outcome Measure >= MCID (Established/Published) From Baseline to Week 52 in Total VAS Scores - by Treatment Week
End of Study (Visit 8 - Week 52) · No
|
17 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. Additionally, some patients missed assessments at various timepoints.
The following table depicts the count of participants that decreased, increased, or did not change their Parkinson's disease medication dosage over the course of the study at various timepoints. The safety analysis set (30 patients in Placebo, 30 patients in HB-adMSCs) was assessed at the various timepoints.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Summary of PD Medication Dose Changes by Visit
End of Study (Visit 8 - Week 52) · Dose increase
|
9 Participants
|
8 Participants
|
|
Summary of PD Medication Dose Changes by Visit
Infusion 3 (Visit 4 - Week 8) · Dose decrease
|
2 Participants
|
2 Participants
|
|
Summary of PD Medication Dose Changes by Visit
Infusion 3 (Visit 4 - Week 8) · No change
|
24 Participants
|
25 Participants
|
|
Summary of PD Medication Dose Changes by Visit
Infusion 3 (Visit 4 - Week 8) · Dose increase
|
2 Participants
|
3 Participants
|
|
Summary of PD Medication Dose Changes by Visit
Infusion 4 (Visit 5 - Week 12) · Dose decrease
|
3 Participants
|
3 Participants
|
|
Summary of PD Medication Dose Changes by Visit
Infusion 4 (Visit 5 - Week 12) · No change
|
21 Participants
|
22 Participants
|
|
Summary of PD Medication Dose Changes by Visit
Infusion 4 (Visit 5 - Week 12) · Dose increase
|
4 Participants
|
5 Participants
|
|
Summary of PD Medication Dose Changes by Visit
Infusion 2 (Visit 3 - Week 4) · No change
|
29 Participants
|
29 Participants
|
|
Summary of PD Medication Dose Changes by Visit
Infusion 2 (Visit 3 - Week 4) · Dose increase
|
1 Participants
|
1 Participants
|
|
Summary of PD Medication Dose Changes by Visit
Infusion 2 (Visit 3 - Week 4) · Dose decrease
|
0 Participants
|
0 Participants
|
|
Summary of PD Medication Dose Changes by Visit
Infusion 5 (Visit 6 - Week 16) · Dose decrease
|
5 Participants
|
4 Participants
|
|
Summary of PD Medication Dose Changes by Visit
Infusion 5 (Visit 6 - Week 16) · No change
|
19 Participants
|
21 Participants
|
|
Summary of PD Medication Dose Changes by Visit
Infusion 5 (Visit 6 - Week 16) · Dose increase
|
3 Participants
|
5 Participants
|
|
Summary of PD Medication Dose Changes by Visit
Infusion 6 (Visit 7 - Week 20) · Dose decrease
|
6 Participants
|
4 Participants
|
|
Summary of PD Medication Dose Changes by Visit
Infusion 6 (Visit 7 - Week 20) · No change
|
17 Participants
|
20 Participants
|
|
Summary of PD Medication Dose Changes by Visit
Infusion 6 (Visit 7 - Week 20) · Dose increase
|
4 Participants
|
5 Participants
|
|
Summary of PD Medication Dose Changes by Visit
Follow-Up 1 (Visit N/A - Week 24) · Dose decrease
|
5 Participants
|
4 Participants
|
|
Summary of PD Medication Dose Changes by Visit
Follow-Up 1 (Visit N/A - Week 24) · No change
|
16 Participants
|
19 Participants
|
|
Summary of PD Medication Dose Changes by Visit
Follow-Up 1 (Visit N/A - Week 24) · Dose increase
|
4 Participants
|
6 Participants
|
|
Summary of PD Medication Dose Changes by Visit
Follow-Up 2 (Visit N/A - Week 32 · Dose decrease
|
5 Participants
|
6 Participants
|
|
Summary of PD Medication Dose Changes by Visit
Follow-Up 2 (Visit N/A - Week 32 · No change
|
14 Participants
|
15 Participants
|
|
Summary of PD Medication Dose Changes by Visit
Follow-Up 2 (Visit N/A - Week 32 · Dose increase
|
3 Participants
|
4 Participants
|
|
Summary of PD Medication Dose Changes by Visit
End of Study (Visit 8 - Week 52) · Dose decrease
|
7 Participants
|
6 Participants
|
|
Summary of PD Medication Dose Changes by Visit
End of Study (Visit 8 - Week 52) · No change
|
7 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. Additionally, some patients missed assessments at various timepoints.
The table prior to this one depicts the count of participants that decreased, increased, or did not change their Parkinson's disease medication dosage over the course of the study at various timepoints. This table depicts the count of participants that reinstated their dose of Parkinson's disease medications after decreasing it throughout the clinical trial. The safety analysis set (30 patients in Placebo, 30 patients in HB-adMSCs) was assessed at the various timepoints.
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Summary of PD Medication Reinstatement by Visit
Infusion 2 (Visit 3 - Week 4) · Dose decrease - Reinstated
|
0 Participants
|
0 Participants
|
|
Summary of PD Medication Reinstatement by Visit
Infusion 2 (Visit 3 - Week 4) · Other (See Dose Change Table)
|
30 Participants
|
30 Participants
|
|
Summary of PD Medication Reinstatement by Visit
Infusion 3 (Visit 4 - Week 8) · Dose decrease - Reinstated
|
0 Participants
|
0 Participants
|
|
Summary of PD Medication Reinstatement by Visit
Infusion 3 (Visit 4 - Week 8) · Other (See Dose Change Table)
|
28 Participants
|
30 Participants
|
|
Summary of PD Medication Reinstatement by Visit
Infusion 4 (Visit 5 - Week 12) · Dose decrease - Reinstated
|
1 Participants
|
0 Participants
|
|
Summary of PD Medication Reinstatement by Visit
Infusion 4 (Visit 5 - Week 12) · Other (See Dose Change Table)
|
27 Participants
|
30 Participants
|
|
Summary of PD Medication Reinstatement by Visit
Infusion 5 (Visit 6 - Week 16) · Dose decrease - Reinstated
|
1 Participants
|
0 Participants
|
|
Summary of PD Medication Reinstatement by Visit
Infusion 5 (Visit 6 - Week 16) · Other (See Dose Change Table)
|
26 Participants
|
30 Participants
|
|
Summary of PD Medication Reinstatement by Visit
Infusion 6 (Visit 7 - Week 20) · Dose decrease - Reinstated
|
1 Participants
|
0 Participants
|
|
Summary of PD Medication Reinstatement by Visit
Infusion 6 (Visit 7 - Week 20) · Other (See Dose Change Table)
|
26 Participants
|
29 Participants
|
|
Summary of PD Medication Reinstatement by Visit
Follow-Up 1 (Visit N/A - Week 24) · Dose decrease - Reinstated
|
2 Participants
|
0 Participants
|
|
Summary of PD Medication Reinstatement by Visit
Follow-Up 1 (Visit N/A - Week 24) · Other (See Dose Change Table)
|
23 Participants
|
29 Participants
|
|
Summary of PD Medication Reinstatement by Visit
Follow-Up 2 (Visit N/A - Week 32 · Dose decrease - Reinstated
|
2 Participants
|
0 Participants
|
|
Summary of PD Medication Reinstatement by Visit
Follow-Up 2 (Visit N/A - Week 32 · Other (See Dose Change Table)
|
20 Participants
|
25 Participants
|
|
Summary of PD Medication Reinstatement by Visit
End of Study (Visit 8 - Week 52) · Dose decrease - Reinstated
|
2 Participants
|
1 Participants
|
|
Summary of PD Medication Reinstatement by Visit
End of Study (Visit 8 - Week 52) · Other (See Dose Change Table)
|
21 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit. Additionally, some patients missed assessments at various timepoints.
Unit (# of participants) - Treatment emergent Adverse events (Subjects with \>= 1 adverse event) - Summary - Safety analysis set. Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Treatment Emergent Adverse Events (Subjects With >= 1 Adverse Event) - Summary - Safety Analysis Set
|
21 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: The total number of enrolled participants in this study (the safety analysis set) that have had an occurrence of at least 1 adverse event is 21 placebo participants and 24 treatment participants.
Unit (# of participants) - Treatment emergent Adverse events (Serious AEs) - Summary - Safety analysis set. Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
Outcome measures
| Measure |
Placebo
n=21 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=24 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Treatment Emergent Adverse Events (Serious AEs) - Summary - Safety Analysis Set
No (Not serious)
|
21 Participants
|
23 Participants
|
|
Treatment Emergent Adverse Events (Serious AEs) - Summary - Safety Analysis Set
Yes (Serious)
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Unit (x10\^9 cells/L) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]
Neutrophils - Baseline (Visit 1 - Week 1) - Absolute
|
3.639 10^9 cells/L
Standard Deviation 1.7025
|
3.413 10^9 cells/L
Standard Deviation 1.1692
|
|
Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]
Neutrophils- Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
0.359 10^9 cells/L
Standard Deviation 1.7776
|
0.004 10^9 cells/L
Standard Deviation 1.1337
|
|
Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]
Neutrophils - End of Study (Visit 8 - Week 52) - Change From Baseline
|
-0.011 10^9 cells/L
Standard Deviation 1.0094
|
-0.005 10^9 cells/L
Standard Deviation 1.1354
|
|
Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]
Lymphocytes - Baseline (Visit 1 - Week 1) - Absolute
|
1.731 10^9 cells/L
Standard Deviation 0.5477
|
1.569 10^9 cells/L
Standard Deviation 0.4914
|
|
Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]
Lymphocytes- Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
0.034 10^9 cells/L
Standard Deviation 0.3918
|
0.051 10^9 cells/L
Standard Deviation 0.3170
|
|
Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]
Lymphocytes - End of Study (Visit 8 - Week 52) - Change From Baseline
|
0.058 10^9 cells/L
Standard Deviation 0.2813
|
0.035 10^9 cells/L
Standard Deviation 0.3129
|
|
Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]
Monocytes - Baseline (Visit 1 - Week 1) - Absolute
|
0.474 10^9 cells/L
Standard Deviation 0.1580
|
0.411 10^9 cells/L
Standard Deviation 0.1331
|
|
Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]
Monocytes- Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
0.016 10^9 cells/L
Standard Deviation 0.1418
|
0.029 10^9 cells/L
Standard Deviation 0.1128
|
|
Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]
Monocytes - End of Study (Visit 8 - Week 52) - Change From Baseline
|
0.019 10^9 cells/L
Standard Deviation 0.1272
|
0.040 10^9 cells/L
Standard Deviation 0.1434
|
|
Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]
Basophils - Baseline (Visit 1 - Week 1) - Absolute
|
0.043 10^9 cells/L
Standard Deviation 0.0199
|
0.040 10^9 cells/L
Standard Deviation 0.0198
|
|
Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]
Basophils - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
0.003 10^9 cells/L
Standard Deviation 0.0156
|
0.004 10^9 cells/L
Standard Deviation 0.0165
|
|
Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]
Basophils - End of Study (Visit 8 - Week 52) - Change From Baseline
|
0.003 10^9 cells/L
Standard Deviation 0.0124
|
0.004 10^9 cells/L
Standard Deviation 0.0171
|
|
Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]
Eosinophils - Baseline (Visit 1 - Week 1) - Absolute
|
0.145 10^9 cells/L
Standard Deviation 0.1145
|
0.142 10^9 cells/L
Standard Deviation 0.1279
|
|
Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]
Eosinophils - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-0.003 10^9 cells/L
Standard Deviation 0.0704
|
0.010 10^9 cells/L
Standard Deviation 0.0808
|
|
Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]
Eosinophils - End of Study (Visit 8 - Week 52) - Change From Baseline
|
0.000 10^9 cells/L
Standard Deviation 0.0736
|
-0.010 10^9 cells/L
Standard Deviation 0.0673
|
|
Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]
Platelets - Baseline (Visit 1 - Week 1) - Absolute
|
248.6 10^9 cells/L
Standard Deviation 54.29
|
230.2 10^9 cells/L
Standard Deviation 51.49
|
|
Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]
Platelets- Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-11.2 10^9 cells/L
Standard Deviation 28.92
|
5.8 10^9 cells/L
Standard Deviation 31.50
|
|
Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]
Platelets - End of Study (Visit 8 - Week 52) - Change From Baseline
|
-9.0 10^9 cells/L
Standard Deviation 28.21
|
9.8 10^9 cells/L
Standard Deviation 30.45
|
|
Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]
Leukocytes - Baseline (Visit 1 - Week 1) - Absolute
|
6.05 10^9 cells/L
Standard Deviation 1.860
|
5.59 10^9 cells/L
Standard Deviation 1.426
|
|
Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]
Leukocytes- Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
0.41 10^9 cells/L
Standard Deviation 1.834
|
0.10 10^9 cells/L
Standard Deviation 1.281
|
|
Change From Baseline Laboratory Values - CBC (x10^9 Cells/L) [Time Frame: Baseline to Week 52]
Leukocytes - End of Study (Visit 8 - Week 52) - Change From Baseline
|
0.07 10^9 cells/L
Standard Deviation 1.102
|
0.06 10^9 cells/L
Standard Deviation 1.275
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Unit (%) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]
Basophils/Leukocytes - Baseline (Visit 1 - Week 1) - Absolute
|
0.74 % of white blood cell count
Standard Deviation 0.475
|
0.81 % of white blood cell count
Standard Deviation 0.787
|
|
Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]
Basophils/Leukocytes - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
0.27 % of white blood cell count
Standard Deviation 0.782
|
0.11 % of white blood cell count
Standard Deviation 0.854
|
|
Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]
Basophils/Leukocytes - End of Study (Visit 8 - Week 52) - Change From Baseline
|
-0.05 % of white blood cell count
Standard Deviation 0.753
|
-0.04 % of white blood cell count
Standard Deviation 0.880
|
|
Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]
Eosinophils/Leukocytes - Baseline (Visit 1 - Week 1) - Absolute
|
2.43 % of white blood cell count
Standard Deviation 1.931
|
2.28 % of white blood cell count
Standard Deviation 1.744
|
|
Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]
Eosinophils/Leukocytes - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-0.11 % of white blood cell count
Standard Deviation 1.536
|
-0.02 % of white blood cell count
Standard Deviation 1.751
|
|
Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]
Eosinophils/Leukocytes - End of Study (Visit 8 - Week 52) - Change From Baseline
|
0.15 % of white blood cell count
Standard Deviation 1.421
|
-0.10 % of white blood cell count
Standard Deviation 1.173
|
|
Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]
Hematocrit - Baseline (Visit 1 - Week 1) - Absolute
|
42.43 % of white blood cell count
Standard Deviation 3.339
|
41.64 % of white blood cell count
Standard Deviation 2.661
|
|
Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]
Hematocrit- Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-0.04 % of white blood cell count
Standard Deviation 2.042
|
-0.31 % of white blood cell count
Standard Deviation 2.240
|
|
Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]
Hematocrit - End of Study (Visit 8 - Week 52) - Change From Baseline
|
-0.06 % of white blood cell count
Standard Deviation 2.297
|
0.38 % of white blood cell count
Standard Deviation 2.198
|
|
Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]
Lymphocytes/Leukocytes - Baseline (Visit 1 - Week 1) - Absolute
|
30.72 % of white blood cell count
Standard Deviation 10.686
|
31.24 % of white blood cell count
Standard Deviation 9.531
|
|
Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]
Lymphocytes/Leukocytes- Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-0.76 % of white blood cell count
Standard Deviation 7.798
|
0.01 % of white blood cell count
Standard Deviation 9.239
|
|
Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]
Lymphocytes/Leukocytes - End of Study (Visit 8 - Week 52) - Change From Baseline
|
-0.52 % of white blood cell count
Standard Deviation 6.868
|
-1.13 % of white blood cell count
Standard Deviation 8.008
|
|
Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]
Monocytes/Leukocytes - Baseline (Visit 1 - Week 1) - Absolute
|
7.88 % of white blood cell count
Standard Deviation 2.629
|
7.24 % of white blood cell count
Standard Deviation 3.030
|
|
Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]
Monocytes/Leukocytes- Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
0.26 % of white blood cell count
Standard Deviation 2.760
|
0.28 % of white blood cell count
Standard Deviation 2.926
|
|
Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]
Monocytes/Leukocytes - End of Study (Visit 8 - Week 52) - Change From Baseline
|
0.00 % of white blood cell count
Standard Deviation 3.404
|
0.62 % of white blood cell count
Standard Deviation 2.953
|
|
Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]
Neutrophils/Leukocytes - Baseline (Visit 1 - Week 1) - Absolute
|
58.05 % of white blood cell count
Standard Deviation 11.707
|
58.31 % of white blood cell count
Standard Deviation 9.944
|
|
Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]
Neutrophils/Leukocytes- Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
0.35 % of white blood cell count
Standard Deviation 9.532
|
-0.45 % of white blood cell count
Standard Deviation 8.571
|
|
Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]
Neutrophils/Leukocytes - End of Study (Visit 8 - Week 52) - Change From Baseline
|
0.35 % of white blood cell count
Standard Deviation 7.686
|
0.55 % of white blood cell count
Standard Deviation 8.199
|
|
Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]
Erythrocytes Distribution Width - Baseline (Visit 1 - Week 1) - Absolute
|
12.73 % of white blood cell count
Standard Deviation 0.557
|
12.68 % of white blood cell count
Standard Deviation 0.529
|
|
Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]
Erythrocytes Distribution Width- Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
0.16 % of white blood cell count
Standard Deviation 0.482
|
-0.01 % of white blood cell count
Standard Deviation 0.522
|
|
Change From Baseline Laboratory Values - CBC (%) [Time Frame: Baseline to Week 52]
Erythrocytes Distribution Width - End of Study (Visit 8 - Week 52) - Change From Baseline
|
-0.05 % of white blood cell count
Standard Deviation 0.466
|
-0.11 % of white blood cell count
Standard Deviation 0.392
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Unit (g/dL) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline Laboratory Values - CBC (g/dL) [Time Frame: Baseline to Week 52]
Hemoglobin - Baseline (Visit 1 - Week 1) - Absolute
|
14.20 g/dL
Standard Deviation 1.168
|
14.03 g/dL
Standard Deviation 0.961
|
|
Change From Baseline Laboratory Values - CBC (g/dL) [Time Frame: Baseline to Week 52]
Hemoglobin - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-0.10 g/dL
Standard Deviation 0.725
|
-0.24 g/dL
Standard Deviation 0.713
|
|
Change From Baseline Laboratory Values - CBC (g/dL) [Time Frame: Baseline to Week 52]
Hemoglobin - End of Study (Visit 8 - Week 52) - Change From Baseline
|
-0.16 g/dL
Standard Deviation 0.724
|
-0.02 g/dL
Standard Deviation 0.708
|
|
Change From Baseline Laboratory Values - CBC (g/dL) [Time Frame: Baseline to Week 52]
Ery. Mean Corpuscular HGB Concentration - Baseline (Visit 1 - Week 1) - Absolute
|
33.48 g/dL
Standard Deviation 0.855
|
33.71 g/dL
Standard Deviation 0.866
|
|
Change From Baseline Laboratory Values - CBC (g/dL) [Time Frame: Baseline to Week 52]
Ery. Mean Corpuscular HGB Concentration - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-0.22 g/dL
Standard Deviation 0.818
|
-0.34 g/dL
Standard Deviation 0.802
|
|
Change From Baseline Laboratory Values - CBC (g/dL) [Time Frame: Baseline to Week 52]
Ery. Mean Corpuscular HGB Concentration - End of Study (Visit 8 - Week 52) - Change From Baseline
|
-0.35 g/dL
Standard Deviation 0.980
|
-0.35 g/dL
Standard Deviation 0.784
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Unit (pg) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline Laboratory Values - CBC (pg) [Time Frame: Baseline to Week 52]
Ery. Mean Corpuscular Hemoglobin - Baseline (Visit 1 - Week 1) - Absolute
|
30.32 pg
Standard Deviation 1.703
|
30.74 pg
Standard Deviation 1.714
|
|
Change From Baseline Laboratory Values - CBC (pg) [Time Frame: Baseline to Week 52]
Ery. Mean Corpuscular Hemoglobin - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-0.10 pg
Standard Deviation 0.785
|
-0.09 pg
Standard Deviation 0.636
|
|
Change From Baseline Laboratory Values - CBC (pg) [Time Frame: Baseline to Week 52]
Ery. Mean Corpuscular Hemoglobin - End of Study (Visit 8 - Week 52) - Change From Baseline
|
0.10 pg
Standard Deviation 0.670
|
0.05 pg
Standard Deviation 0.773
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Unit (fL) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline Laboratory Values - CBC (fL) [Time Frame: Baseline to Week 52]
Ery. Mean Corpuscular Volume - Baseline (Visit 1 - Week 1) - Absolute
|
90.59 fL
Standard Deviation 4.419
|
91.22 fL
Standard Deviation 4.496
|
|
Change From Baseline Laboratory Values - CBC (fL) [Time Frame: Baseline to Week 52]
Ery. Mean Corpuscular Volume - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
0.28 fL
Standard Deviation 1.977
|
0.62 fL
Standard Deviation 1.689
|
|
Change From Baseline Laboratory Values - CBC (fL) [Time Frame: Baseline to Week 52]
Ery. Mean Corpuscular Volume - End of Study (Visit 8 - Week 52) - Change From Baseline
|
1.19 fL
Standard Deviation 2.055
|
1.05 fL
Standard Deviation 1.920
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Unit (10\^12/L) - Change From Baseline Clinical Laboratory Complete Blood Count (CBC) by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline Laboratory Values - CBC (10^12/L) [Time Frame: Baseline to Week 52]
Erythrocytes - Baseline (Visit 1 - Week 1) - Absolute
|
4.693 cells * 10^12/L
Standard Deviation 0.4131
|
4.577 cells * 10^12/L
Standard Deviation 0.3904
|
|
Change From Baseline Laboratory Values - CBC (10^12/L) [Time Frame: Baseline to Week 52]
Erythrocytes - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-0.023 cells * 10^12/L
Standard Deviation 0.2190
|
-0.067 cells * 10^12/L
Standard Deviation 0.2374
|
|
Change From Baseline Laboratory Values - CBC (10^12/L) [Time Frame: Baseline to Week 52]
Erythrocytes - End of Study (Visit 8 - Week 52) - Change From Baseline
|
-0.066 cells * 10^12/L
Standard Deviation 0.2144
|
-0.019 cells * 10^12/L
Standard Deviation 0.2608
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Unit (g/dL) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline Laboratory Values - CMP (g/dL) [Time Frame: Baseline to Week 52]
Albumin - Baseline (Visit 1 - Week 1) - Absolute
|
4.55 g/dL
Standard Deviation 0.292
|
4.59 g/dL
Standard Deviation 0.285
|
|
Change From Baseline Laboratory Values - CMP (g/dL) [Time Frame: Baseline to Week 52]
Albumin - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-0.05 g/dL
Standard Deviation 0.223
|
-0.04 g/dL
Standard Deviation 0.330
|
|
Change From Baseline Laboratory Values - CMP (g/dL) [Time Frame: Baseline to Week 52]
Albumin - End of Study (Visit 8 - Week 52) - Change From Baseline
|
-0.17 g/dL
Standard Deviation 0.315
|
-0.06 g/dL
Standard Deviation 0.259
|
|
Change From Baseline Laboratory Values - CMP (g/dL) [Time Frame: Baseline to Week 52]
Globulin - Baseline (Visit 1 - Week 1) - Absolute
|
2.46 g/dL
Standard Deviation 0.363
|
2.31 g/dL
Standard Deviation 0.389
|
|
Change From Baseline Laboratory Values - CMP (g/dL) [Time Frame: Baseline to Week 52]
Globulin - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-0.03 g/dL
Standard Deviation 0.246
|
0.08 g/dL
Standard Deviation 0.327
|
|
Change From Baseline Laboratory Values - CMP (g/dL) [Time Frame: Baseline to Week 52]
Globulin- End of Study (Visit 8 - Week 52) - Change From Baseline
|
-0.04 g/dL
Standard Deviation 0.282
|
0.06 g/dL
Standard Deviation 0.335
|
|
Change From Baseline Laboratory Values - CMP (g/dL) [Time Frame: Baseline to Week 52]
Protein - Baseline (Visit 1 - Week 1) - Absolute
|
7.01 g/dL
Standard Deviation 0.309
|
6.90 g/dL
Standard Deviation 0.507
|
|
Change From Baseline Laboratory Values - CMP (g/dL) [Time Frame: Baseline to Week 52]
Protein - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-0.08 g/dL
Standard Deviation 0.294
|
0.05 g/dL
Standard Deviation 0.386
|
|
Change From Baseline Laboratory Values - CMP (g/dL) [Time Frame: Baseline to Week 52]
Protein- End of Study (Visit 8 - Week 52) - Change From Baseline
|
-0.21 g/dL
Standard Deviation 0.321
|
0.00 g/dL
Standard Deviation 0.314
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Unit (Ratio) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline Laboratory Values - CMP (Ratio) [Time Frame: Baseline to Week 52]
Albumin/Globulin - Baseline (Visit 1 - Week 1) - Absolute
|
1.89 Ratio
Standard Deviation 0.308
|
2.03 Ratio
Standard Deviation 0.322
|
|
Change From Baseline Laboratory Values - CMP (Ratio) [Time Frame: Baseline to Week 52]
Albumin/Globulin - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
0.00 Ratio
Standard Deviation 0.241
|
-0.07 Ratio
Standard Deviation 0.356
|
|
Change From Baseline Laboratory Values - CMP (Ratio) [Time Frame: Baseline to Week 52]
Albumin/Globulin - End of Study (Visit 8 - Week 52) - Change From Baseline
|
-0.05 Ratio
Standard Deviation 0.250
|
-0.10 Ratio
Standard Deviation 0.323
|
|
Change From Baseline Laboratory Values - CMP (Ratio) [Time Frame: Baseline to Week 52]
Urea Nitrogen/Creatinine - Baseline (Visit 1 - Week 1) - Absolute
|
19.4 Ratio
Standard Deviation 5.78
|
19.9 Ratio
Standard Deviation 4.74
|
|
Change From Baseline Laboratory Values - CMP (Ratio) [Time Frame: Baseline to Week 52]
Urea Nitrogen/Creatinine - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
1.1 Ratio
Standard Deviation 5.24
|
1.4 Ratio
Standard Deviation 4.26
|
|
Change From Baseline Laboratory Values - CMP (Ratio) [Time Frame: Baseline to Week 52]
Urea Nitrogen/Creatinine- End of Study (Visit 8 - Week 52) - Change From Baseline
|
-0.0 Ratio
Standard Deviation 4.46
|
0.6 Ratio
Standard Deviation 3.36
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Unit (IU/L) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline Laboratory Values - CMP (IU/L) [Time Frame: Baseline to Week 52]
Alkaline Phosphatase - Baseline (Visit 1 - Week 1) - Absolute
|
78.4 IU/L
Standard Deviation 20.55
|
78.6 IU/L
Standard Deviation 20.81
|
|
Change From Baseline Laboratory Values - CMP (IU/L) [Time Frame: Baseline to Week 52]
Alkaline Phosphatase - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-1.6 IU/L
Standard Deviation 9.15
|
-1.6 IU/L
Standard Deviation 7.43
|
|
Change From Baseline Laboratory Values - CMP (IU/L) [Time Frame: Baseline to Week 52]
Alkaline Phosphatase - End of Study (Visit 8 - Week 52) - Change From Baseline
|
4.5 IU/L
Standard Deviation 18.73
|
2.1 IU/L
Standard Deviation 13.13
|
|
Change From Baseline Laboratory Values - CMP (IU/L) [Time Frame: Baseline to Week 52]
Alanine Aminotransferase - Baseline (Visit 1 - Week 1) - Absolute
|
15.8 IU/L
Standard Deviation 9.84
|
15.7 IU/L
Standard Deviation 9.61
|
|
Change From Baseline Laboratory Values - CMP (IU/L) [Time Frame: Baseline to Week 52]
Alanine Aminotransferase - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
0.4 IU/L
Standard Deviation 8.19
|
3.0 IU/L
Standard Deviation 10.65
|
|
Change From Baseline Laboratory Values - CMP (IU/L) [Time Frame: Baseline to Week 52]
Alanine Aminotransferase- End of Study (Visit 8 - Week 52) - Change From Baseline
|
-0.7 IU/L
Standard Deviation 14.24
|
-0.1 IU/L
Standard Deviation 10.44
|
|
Change From Baseline Laboratory Values - CMP (IU/L) [Time Frame: Baseline to Week 52]
Aspartate Aminotransferase - Baseline (Visit 1 - Week 1) - Absolute
|
22.2 IU/L
Standard Deviation 6.71
|
20.1 IU/L
Standard Deviation 6.84
|
|
Change From Baseline Laboratory Values - CMP (IU/L) [Time Frame: Baseline to Week 52]
Aspartate Aminotransferase - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
0.9 IU/L
Standard Deviation 7.68
|
2.7 IU/L
Standard Deviation 5.83
|
|
Change From Baseline Laboratory Values - CMP (IU/L) [Time Frame: Baseline to Week 52]
Aspartate Aminotransferase- End of Study (Visit 8 - Week 52) - Change From Baseline
|
-0.4 IU/L
Standard Deviation 6.03
|
0.4 IU/L
Standard Deviation 5.35
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Unit (mg/dL) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline Laboratory Values - CMP (mg/dL) [Time Frame: Baseline to Week 52]
Bilirubin - Baseline (Visit 1 - Week 1) - Absolute
|
0.72 mg/dL
Standard Deviation 0.450
|
0.68 mg/dL
Standard Deviation 0.342
|
|
Change From Baseline Laboratory Values - CMP (mg/dL) [Time Frame: Baseline to Week 52]
Bilirubin - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-0.04 mg/dL
Standard Deviation 0.182
|
-0.03 mg/dL
Standard Deviation 0.289
|
|
Change From Baseline Laboratory Values - CMP (mg/dL) [Time Frame: Baseline to Week 52]
Bilirubin - End of Study (Visit 8 - Week 52) - Change From Baseline
|
-0.02 mg/dL
Standard Deviation 0.271
|
-0.06 mg/dL
Standard Deviation 0.262
|
|
Change From Baseline Laboratory Values - CMP (mg/dL) [Time Frame: Baseline to Week 52]
Calcium- Baseline (Visit 1 - Week 1) - Absolute
|
9.61 mg/dL
Standard Deviation 0.361
|
9.51 mg/dL
Standard Deviation 0.386
|
|
Change From Baseline Laboratory Values - CMP (mg/dL) [Time Frame: Baseline to Week 52]
Calcium - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-0.11 mg/dL
Standard Deviation 0.289
|
0.02 mg/dL
Standard Deviation 0.352
|
|
Change From Baseline Laboratory Values - CMP (mg/dL) [Time Frame: Baseline to Week 52]
Calcium- End of Study (Visit 8 - Week 52) - Change From Baseline
|
-0.07 mg/dL
Standard Deviation 0.501
|
0.02 mg/dL
Standard Deviation 0.399
|
|
Change From Baseline Laboratory Values - CMP (mg/dL) [Time Frame: Baseline to Week 52]
Creatinine - Baseline (Visit 1 - Week 1) - Absolute
|
0.904 mg/dL
Standard Deviation 0.1777
|
0.883 mg/dL
Standard Deviation 0.1782
|
|
Change From Baseline Laboratory Values - CMP (mg/dL) [Time Frame: Baseline to Week 52]
Creatinine - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-0.029 mg/dL
Standard Deviation 0.0780
|
-0.040 mg/dL
Standard Deviation 0.1123
|
|
Change From Baseline Laboratory Values - CMP (mg/dL) [Time Frame: Baseline to Week 52]
Creatinine- End of Study (Visit 8 - Week 52) - Change From Baseline
|
-0.020 mg/dL
Standard Deviation 0.1068
|
0.036 mg/dL
Standard Deviation 0.1011
|
|
Change From Baseline Laboratory Values - CMP (mg/dL) [Time Frame: Baseline to Week 52]
Glucose - Baseline (Visit 1 - Week 1) - Absolute
|
98.7 mg/dL
Standard Deviation 9.66
|
101.7 mg/dL
Standard Deviation 16.39
|
|
Change From Baseline Laboratory Values - CMP (mg/dL) [Time Frame: Baseline to Week 52]
Glucose - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-0.8 mg/dL
Standard Deviation 10.33
|
-1.1 mg/dL
Standard Deviation 11.89
|
|
Change From Baseline Laboratory Values - CMP (mg/dL) [Time Frame: Baseline to Week 52]
Glucose- End of Study (Visit 8 - Week 52) - Change From Baseline
|
2.0 mg/dL
Standard Deviation 16.52
|
-2.2 mg/dL
Standard Deviation 14.83
|
|
Change From Baseline Laboratory Values - CMP (mg/dL) [Time Frame: Baseline to Week 52]
Urea Nitrogen - Baseline (Visit 1 - Week 1) - Absolute
|
17.1 mg/dL
Standard Deviation 4.61
|
17.5 mg/dL
Standard Deviation 5.11
|
|
Change From Baseline Laboratory Values - CMP (mg/dL) [Time Frame: Baseline to Week 52]
Urea Nitrogen - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
0.4 mg/dL
Standard Deviation 4.65
|
0.1 mg/dL
Standard Deviation 3.64
|
|
Change From Baseline Laboratory Values - CMP (mg/dL) [Time Frame: Baseline to Week 52]
Urea Nitrogen- End of Study (Visit 8 - Week 52) - Change From Baseline
|
-0.1 mg/dL
Standard Deviation 3.97
|
1.3 mg/dL
Standard Deviation 3.56
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Unit (mmol/L) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline Laboratory Values - CMP (mmol/L) [Time Frame: Baseline to Week 52]
Chloride- Baseline (Visit 1 - Week 1) - Absolute
|
104.0 mmol/L
Standard Deviation 2.30
|
104.3 mmol/L
Standard Deviation 2.17
|
|
Change From Baseline Laboratory Values - CMP (mmol/L) [Time Frame: Baseline to Week 52]
Chloride - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-0.4 mmol/L
Standard Deviation 2.56
|
-0.6 mmol/L
Standard Deviation 1.90
|
|
Change From Baseline Laboratory Values - CMP (mmol/L) [Time Frame: Baseline to Week 52]
Chloride - End of Study (Visit 8 - Week 52) - Change From Baseline
|
-0.7 mmol/L
Standard Deviation 2.90
|
-0.4 mmol/L
Standard Deviation 2.26
|
|
Change From Baseline Laboratory Values - CMP (mmol/L) [Time Frame: Baseline to Week 52]
Carbon Dioxide - Baseline (Visit 1 - Week 1) - Absolute
|
24.7 mmol/L
Standard Deviation 2.02
|
24.6 mmol/L
Standard Deviation 1.90
|
|
Change From Baseline Laboratory Values - CMP (mmol/L) [Time Frame: Baseline to Week 52]
Carbon Dioxide - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
0.7 mmol/L
Standard Deviation 2.77
|
-0.2 mmol/L
Standard Deviation 2.48
|
|
Change From Baseline Laboratory Values - CMP (mmol/L) [Time Frame: Baseline to Week 52]
Carbon Dioxide- End of Study (Visit 8 - Week 52) - Change From Baseline
|
-0.6 mmol/L
Standard Deviation 2.59
|
0.1 mmol/L
Standard Deviation 2.69
|
|
Change From Baseline Laboratory Values - CMP (mmol/L) [Time Frame: Baseline to Week 52]
Potassium - Baseline (Visit 1 - Week 1) - Absolute
|
4.39 mmol/L
Standard Deviation 0.435
|
4.28 mmol/L
Standard Deviation 0.255
|
|
Change From Baseline Laboratory Values - CMP (mmol/L) [Time Frame: Baseline to Week 52]
Potassium - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-0.08 mmol/L
Standard Deviation 0.472
|
0.05 mmol/L
Standard Deviation 0.385
|
|
Change From Baseline Laboratory Values - CMP (mmol/L) [Time Frame: Baseline to Week 52]
Potassium - End of Study (Visit 8 - Week 52) - Change From Baseline
|
-0.09 mmol/L
Standard Deviation 0.334
|
0.04 mmol/L
Standard Deviation 0.390
|
|
Change From Baseline Laboratory Values - CMP (mmol/L) [Time Frame: Baseline to Week 52]
Sodium - Baseline (Visit 1 - Week 1) - Absolute
|
141.6 mmol/L
Standard Deviation 2.19
|
141.4 mmol/L
Standard Deviation 2.95
|
|
Change From Baseline Laboratory Values - CMP (mmol/L) [Time Frame: Baseline to Week 52]
Sodium - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-0.4 mmol/L
Standard Deviation 2.55
|
-0.7 mmol/L
Standard Deviation 2.28
|
|
Change From Baseline Laboratory Values - CMP (mmol/L) [Time Frame: Baseline to Week 52]
Sodium - End of Study (Visit 8 - Week 52) - Change From Baseline
|
-1.2 mmol/L
Standard Deviation 3.17
|
-0.3 mmol/L
Standard Deviation 2.68
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Unit (mL/min/1.73 m\^2) - Change From Baseline Clinical Laboratory Comprehensive Metabolic Panel (CMP) by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline Laboratory Values - CMP (mL/Min/1.73 m^2) [Time Frame: Baseline to Week 52]
eGFR - Baseline (Visit 1 - Week 1) - Absolute
|
87.6 mL/min/1.73 m^2
Standard Deviation 13.40
|
88.5 mL/min/1.73 m^2
Standard Deviation 14.10
|
|
Change From Baseline Laboratory Values - CMP (mL/Min/1.73 m^2) [Time Frame: Baseline to Week 52]
eGFR - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
1.9 mL/min/1.73 m^2
Standard Deviation 6.31
|
3.6 mL/min/1.73 m^2
Standard Deviation 10.37
|
|
Change From Baseline Laboratory Values - CMP (mL/Min/1.73 m^2) [Time Frame: Baseline to Week 52]
eGFR - End of Study (Visit 8 - Week 52) - Change From Baseline
|
0.9 mL/min/1.73 m^2
Standard Deviation 9.00
|
-3.2 mL/min/1.73 m^2
Standard Deviation 9.15
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Unit (Ratio) - Change From Baseline Clinical Laboratory Coagulation Panel by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline Laboratory Values - Coagulation Panel (Ratio) [Time Frame: Baseline to Week 52]
Prothrombin Intl. Normalized Ratio- Baseline (Visit 1 - Week 1) - Absolute
|
1.00 Ratio
Standard Deviation 0.068
|
1.00 Ratio
Standard Deviation 0.074
|
|
Change From Baseline Laboratory Values - Coagulation Panel (Ratio) [Time Frame: Baseline to Week 52]
Prothrombin Intl. Normalized Ratio - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-0.00 Ratio
Standard Deviation 0.077
|
0.01 Ratio
Standard Deviation 0.069
|
|
Change From Baseline Laboratory Values - Coagulation Panel (Ratio) [Time Frame: Baseline to Week 52]
Prothrombin Intl. Normalized Ratio - End of Study (Visit 8 - Week 52) - Change From Baseline
|
0.01 Ratio
Standard Deviation 0.057
|
0.01 Ratio
Standard Deviation 0.066
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Unit (sec.) - Change From Baseline Clinical Laboratory Coagulation Panel by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline Laboratory Values - Coagulation Panel (Sec.) [Time Frame: Baseline to Week 52]
Prothrombin Time - Baseline (Visit 1 - Week 1) - Absolute
|
13.52 seconds
Standard Deviation 0.662
|
13.56 seconds
Standard Deviation 0.637
|
|
Change From Baseline Laboratory Values - Coagulation Panel (Sec.) [Time Frame: Baseline to Week 52]
Prothrombin Time - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-0.08 seconds
Standard Deviation 0.608
|
-0.03 seconds
Standard Deviation 0.565
|
|
Change From Baseline Laboratory Values - Coagulation Panel (Sec.) [Time Frame: Baseline to Week 52]
Prothrombin Time - End of Study (Visit 8 - Week 52) - Change From Baseline
|
0.09 seconds
Standard Deviation 0.457
|
0.11 seconds
Standard Deviation 0.409
|
|
Change From Baseline Laboratory Values - Coagulation Panel (Sec.) [Time Frame: Baseline to Week 52]
Partial Thromboplastin Time - Baseline (Visit 1 - Week 1) - Absolute
|
29.62 seconds
Standard Deviation 3.206
|
30.31 seconds
Standard Deviation 2.857
|
|
Change From Baseline Laboratory Values - Coagulation Panel (Sec.) [Time Frame: Baseline to Week 52]
Partial Thromboplastin Time - Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-1.42 seconds
Standard Deviation 2.681
|
-0.44 seconds
Standard Deviation 1.361
|
|
Change From Baseline Laboratory Values - Coagulation Panel (Sec.) [Time Frame: Baseline to Week 52]
Partial Thromboplastin Time- End of Study (Visit 8 - Week 52) - Change From Baseline
|
0.21 seconds
Standard Deviation 1.170
|
-0.19 seconds
Standard Deviation 1.188
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure - mmHg)
Infusion 4 (Visit 5 - Week 12) - Change From Baseline
|
-2.0 mmHg
Standard Deviation 10.82
|
-4.2 mmHg
Standard Deviation 9.15
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure - mmHg)
Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-4.1 mmHg
Standard Deviation 8.09
|
-1.4 mmHg
Standard Deviation 7.40
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure - mmHg)
Infusion 6 (Visit 7 - Week 20) - Change From Baseline
|
-4.3 mmHg
Standard Deviation 12.33
|
-4.8 mmHg
Standard Deviation 7.36
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure - mmHg)
End of Study (Visit 8 - Week 52) - Change From Baseline
|
-1.7 mmHg
Standard Deviation 9.42
|
-1.3 mmHg
Standard Deviation 6.55
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure - mmHg)
Baseline (Visit 2 - Week 1) - Absolute
|
81.1 mmHg
Standard Deviation 9.39
|
78.8 mmHg
Standard Deviation 8.98
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure - mmHg)
Infusion 2 (Visit 3 - Week 4) - Change From Baseline
|
-2.1 mmHg
Standard Deviation 8.24
|
-3.8 mmHg
Standard Deviation 6.97
|
|
Change From Baseline in Vital Signs (Diastolic Blood Pressure - mmHg)
Infusion 3 (Visit 4 - Week 8) - Change From Baseline
|
-2.9 mmHg
Standard Deviation 10.52
|
-1.9 mmHg
Standard Deviation 7.07
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in Vital Signs (Heart Rate - Beats/Min)
End of Study (Visit 8 - Week 52) - Change From Baseline
|
4.3 beats/min
Standard Deviation 7.25
|
1.4 beats/min
Standard Deviation 9.30
|
|
Change From Baseline in Vital Signs (Heart Rate - Beats/Min)
Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
1.9 beats/min
Standard Deviation 8.28
|
-2.2 beats/min
Standard Deviation 8.13
|
|
Change From Baseline in Vital Signs (Heart Rate - Beats/Min)
Infusion 6 (Visit 7 - Week 20) - Change From Baseline
|
6.9 beats/min
Standard Deviation 9.10
|
0.1 beats/min
Standard Deviation 9.60
|
|
Change From Baseline in Vital Signs (Heart Rate - Beats/Min)
Baseline (Visit 2 - Week 1) - Absolute
|
67.1 beats/min
Standard Deviation 11.49
|
69.8 beats/min
Standard Deviation 12.21
|
|
Change From Baseline in Vital Signs (Heart Rate - Beats/Min)
Infusion 2 (Visit 3 - Week 4) - Change From Baseline
|
5.7 beats/min
Standard Deviation 8.09
|
2.0 beats/min
Standard Deviation 6.95
|
|
Change From Baseline in Vital Signs (Heart Rate - Beats/Min)
Infusion 3 (Visit 4 - Week 8) - Change From Baseline
|
3.1 beats/min
Standard Deviation 8.85
|
1.6 beats/min
Standard Deviation 6.04
|
|
Change From Baseline in Vital Signs (Heart Rate - Beats/Min)
Infusion 4 (Visit 5 - Week 12) - Change From Baseline
|
6.8 beats/min
Standard Deviation 9.54
|
1.1 beats/min
Standard Deviation 6.90
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in Vital Signs (Oxygen Saturation - %)
Baseline (Visit 2 - Week 1) - Absolute
|
97.9 SPO2%
Standard Deviation 1.32
|
97.8 SPO2%
Standard Deviation 1.21
|
|
Change From Baseline in Vital Signs (Oxygen Saturation - %)
Infusion 2 (Visit 3 - Week 4) - Change From Baseline
|
-0.8 SPO2%
Standard Deviation 1.43
|
-0.6 SPO2%
Standard Deviation 1.79
|
|
Change From Baseline in Vital Signs (Oxygen Saturation - %)
Infusion 3 (Visit 4 - Week 8) - Change From Baseline
|
-0.9 SPO2%
Standard Deviation 1.57
|
-0.4 SPO2%
Standard Deviation 1.73
|
|
Change From Baseline in Vital Signs (Oxygen Saturation - %)
Infusion 4 (Visit 5 - Week 12) - Change From Baseline
|
-0.8 SPO2%
Standard Deviation 1.64
|
-0.3 SPO2%
Standard Deviation 1.20
|
|
Change From Baseline in Vital Signs (Oxygen Saturation - %)
Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-0.4 SPO2%
Standard Deviation 1.04
|
-0.4 SPO2%
Standard Deviation 1.47
|
|
Change From Baseline in Vital Signs (Oxygen Saturation - %)
Infusion 6 (Visit 7 - Week 20) - Change From Baseline
|
-0.2 SPO2%
Standard Deviation 1.63
|
-0.6 SPO2%
Standard Deviation 1.24
|
|
Change From Baseline in Vital Signs (Oxygen Saturation - %)
End of Study (Visit 8 - Week 52) - Change From Baseline
|
-0.6 SPO2%
Standard Deviation 1.50
|
0.1 SPO2%
Standard Deviation 1.71
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in Vital Signs (Respiration Rate - Breaths/Min)
Baseline (Visit 2 - Week 1) - Absolute
|
16.8 Breaths/min
Standard Deviation 1.00
|
17.1 Breaths/min
Standard Deviation 1.01
|
|
Change From Baseline in Vital Signs (Respiration Rate - Breaths/Min)
Infusion 2 (Visit 3 - Week 4) - Change From Baseline
|
0.5 Breaths/min
Standard Deviation 1.01
|
-0.2 Breaths/min
Standard Deviation 1.42
|
|
Change From Baseline in Vital Signs (Respiration Rate - Breaths/Min)
Infusion 3 (Visit 4 - Week 8) - Change From Baseline
|
0.4 Breaths/min
Standard Deviation 1.22
|
-0.3 Breaths/min
Standard Deviation 1.30
|
|
Change From Baseline in Vital Signs (Respiration Rate - Breaths/Min)
Infusion 4 (Visit 5 - Week 12) - Change From Baseline
|
0.5 Breaths/min
Standard Deviation 1.17
|
0.3 Breaths/min
Standard Deviation 1.40
|
|
Change From Baseline in Vital Signs (Respiration Rate - Breaths/Min)
Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
0.5 Breaths/min
Standard Deviation 1.19
|
-0.1 Breaths/min
Standard Deviation 1.23
|
|
Change From Baseline in Vital Signs (Respiration Rate - Breaths/Min)
Infusion 6 (Visit 7 - Week 20) - Change From Baseline
|
0.4 Breaths/min
Standard Deviation 1.24
|
0.2 Breaths/min
Standard Deviation 1.24
|
|
Change From Baseline in Vital Signs (Respiration Rate - Breaths/Min)
End of Study (Visit 8 - Week 52) - Change From Baseline
|
0.7 Breaths/min
Standard Deviation 0.98
|
0.1 Breaths/min
Standard Deviation 1.02
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure - mmHg)
Baseline (Visit 2 - Week 1) - Absolute
|
133.1 mmHg
Standard Deviation 12.90
|
131.5 mmHg
Standard Deviation 16.20
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure - mmHg)
Infusion 2 (Visit 3 - Week 4) - Change From Baseline
|
-7.6 mmHg
Standard Deviation 12.68
|
-6.4 mmHg
Standard Deviation 17.79
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure - mmHg)
Infusion 3 (Visit 4 - Week 8) - Change From Baseline
|
-2.8 mmHg
Standard Deviation 16.70
|
-6.5 mmHg
Standard Deviation 11.46
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure - mmHg)
Infusion 4 (Visit 5 - Week 12) - Change From Baseline
|
-9.6 mmHg
Standard Deviation 13.79
|
-8.4 mmHg
Standard Deviation 18.13
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure - mmHg)
Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-7.9 mmHg
Standard Deviation 13.61
|
-3.0 mmHg
Standard Deviation 13.15
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure - mmHg)
Infusion 6 (Visit 7 - Week 20) - Change From Baseline
|
-10.1 mmHg
Standard Deviation 17.10
|
-8.3 mmHg
Standard Deviation 16.88
|
|
Change From Baseline in Vital Signs (Systolic Blood Pressure - mmHg)
End of Study (Visit 8 - Week 52) - Change From Baseline
|
-3.5 mmHg
Standard Deviation 14.41
|
-1.3 mmHg
Standard Deviation 15.29
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in Vital Signs (Temperature - Celsius)
Baseline (Visit 2 - Week 1) - Absolute
|
36.61 Celsius
Standard Deviation 0.249
|
36.57 Celsius
Standard Deviation 0.265
|
|
Change From Baseline in Vital Signs (Temperature - Celsius)
Infusion 2 (Visit 3 - Week 4) - Change From Baseline
|
0.07 Celsius
Standard Deviation 0.253
|
-0.02 Celsius
Standard Deviation 0.306
|
|
Change From Baseline in Vital Signs (Temperature - Celsius)
Infusion 3 (Visit 4 - Week 8) - Change From Baseline
|
-0.04 Celsius
Standard Deviation 0.225
|
0.05 Celsius
Standard Deviation 0.281
|
|
Change From Baseline in Vital Signs (Temperature - Celsius)
Infusion 4 (Visit 5 - Week 12) - Change From Baseline
|
0.02 Celsius
Standard Deviation 0.254
|
0.10 Celsius
Standard Deviation 0.272
|
|
Change From Baseline in Vital Signs (Temperature - Celsius)
Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
0.02 Celsius
Standard Deviation 0.269
|
0.11 Celsius
Standard Deviation 0.307
|
|
Change From Baseline in Vital Signs (Temperature - Celsius)
Infusion 6 (Visit 7 - Week 20) - Change From Baseline
|
0.07 Celsius
Standard Deviation 0.280
|
0.12 Celsius
Standard Deviation 0.348
|
|
Change From Baseline in Vital Signs (Temperature - Celsius)
End of Study (Visit 8 - Week 52) - Change From Baseline
|
0.04 Celsius
Standard Deviation 0.323
|
0.02 Celsius
Standard Deviation 0.333
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Change From Baseline Vitals by Treatment Week - Descriptive Statistics - Safety Analysis Set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Change From Baseline in Vital Signs (Weight - kg)
Baseline (Visit 2 - Week 1) - Absolute
|
77.08 kg
Standard Deviation 16.155
|
78.87 kg
Standard Deviation 15.915
|
|
Change From Baseline in Vital Signs (Weight - kg)
Infusion 2 (Visit 3 - Week 4) - Change From Baseline
|
-0.19 kg
Standard Deviation 1.740
|
-0.64 kg
Standard Deviation 2.753
|
|
Change From Baseline in Vital Signs (Weight - kg)
Infusion 3 (Visit 4 - Week 8) - Change From Baseline
|
-0.14 kg
Standard Deviation 2.445
|
-0.70 kg
Standard Deviation 2.732
|
|
Change From Baseline in Vital Signs (Weight - kg)
Infusion 4 (Visit 5 - Week 12) - Change From Baseline
|
0.01 kg
Standard Deviation 2.297
|
-0.48 kg
Standard Deviation 2.920
|
|
Change From Baseline in Vital Signs (Weight - kg)
Infusion 5 (Visit 6 - Week 16) - Change From Baseline
|
-0.55 kg
Standard Deviation 2.680
|
-0.96 kg
Standard Deviation 3.009
|
|
Change From Baseline in Vital Signs (Weight - kg)
Infusion 6 (Visit 7 - Week 20) - Change From Baseline
|
-0.24 kg
Standard Deviation 2.908
|
-0.91 kg
Standard Deviation 2.850
|
|
Change From Baseline in Vital Signs (Weight - kg)
End of Study (Visit 8 - Week 52) - Change From Baseline
|
0.20 kg
Standard Deviation 3.124
|
-1.16 kg
Standard Deviation 3.959
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Physical examination - by treatment week - Summary - Safety analysis set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Physical Examination - by Treatment Week - Abdomen
Baseline (Visit 2 - Week 1) · Normal
|
28 Participants
|
28 Participants
|
|
Physical Examination - by Treatment Week - Abdomen
Baseline (Visit 2 - Week 1) · Abnormal
|
2 Participants
|
2 Participants
|
|
Physical Examination - by Treatment Week - Abdomen
Infusion 2 (Visit 3 - Week 4) · Normal
|
28 Participants
|
28 Participants
|
|
Physical Examination - by Treatment Week - Abdomen
Infusion 2 (Visit 3 - Week 4) · Abnormal
|
2 Participants
|
2 Participants
|
|
Physical Examination - by Treatment Week - Abdomen
Infusion 3 (Visit 4 - Week 8) · Normal
|
26 Participants
|
28 Participants
|
|
Physical Examination - by Treatment Week - Abdomen
Infusion 3 (Visit 4 - Week 8) · Abnormal
|
2 Participants
|
2 Participants
|
|
Physical Examination - by Treatment Week - Abdomen
Infusion 4 (Visit 5 - Week 12) · Normal
|
26 Participants
|
28 Participants
|
|
Physical Examination - by Treatment Week - Abdomen
Infusion 4 (Visit 5 - Week 12) · Abnormal
|
2 Participants
|
2 Participants
|
|
Physical Examination - by Treatment Week - Abdomen
Infusion 5 (Visit 6 - Week 16) · Normal
|
25 Participants
|
28 Participants
|
|
Physical Examination - by Treatment Week - Abdomen
Infusion 5 (Visit 6 - Week 16) · Abnormal
|
2 Participants
|
2 Participants
|
|
Physical Examination - by Treatment Week - Abdomen
Infusion 6 (Visit 7 - Week 20) · Normal
|
25 Participants
|
27 Participants
|
|
Physical Examination - by Treatment Week - Abdomen
Infusion 6 (Visit 7 - Week 20) · Abnormal
|
2 Participants
|
2 Participants
|
|
Physical Examination - by Treatment Week - Abdomen
End of Study (Visit 8 - Week 52) · Normal
|
19 Participants
|
26 Participants
|
|
Physical Examination - by Treatment Week - Abdomen
End of Study (Visit 8 - Week 52) · Abnormal
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Physical examination - by treatment week - Summary - Safety analysis set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Physical Examination - by Treatment Week - Cardiovascular
Baseline (Visit 2 - Week 1) · Normal
|
30 Participants
|
29 Participants
|
|
Physical Examination - by Treatment Week - Cardiovascular
Baseline (Visit 2 - Week 1) · Abnormal
|
0 Participants
|
1 Participants
|
|
Physical Examination - by Treatment Week - Cardiovascular
Infusion 2 (Visit 3 - Week 4) · Normal
|
30 Participants
|
30 Participants
|
|
Physical Examination - by Treatment Week - Cardiovascular
Infusion 2 (Visit 3 - Week 4) · Abnormal
|
0 Participants
|
0 Participants
|
|
Physical Examination - by Treatment Week - Cardiovascular
Infusion 3 (Visit 4 - Week 8) · Normal
|
28 Participants
|
30 Participants
|
|
Physical Examination - by Treatment Week - Cardiovascular
Infusion 3 (Visit 4 - Week 8) · Abnormal
|
0 Participants
|
0 Participants
|
|
Physical Examination - by Treatment Week - Cardiovascular
Infusion 4 (Visit 5 - Week 12) · Normal
|
28 Participants
|
29 Participants
|
|
Physical Examination - by Treatment Week - Cardiovascular
Infusion 4 (Visit 5 - Week 12) · Abnormal
|
0 Participants
|
1 Participants
|
|
Physical Examination - by Treatment Week - Cardiovascular
Infusion 5 (Visit 6 - Week 16) · Normal
|
26 Participants
|
29 Participants
|
|
Physical Examination - by Treatment Week - Cardiovascular
Infusion 5 (Visit 6 - Week 16) · Abnormal
|
1 Participants
|
1 Participants
|
|
Physical Examination - by Treatment Week - Cardiovascular
Infusion 6 (Visit 7 - Week 20) · Normal
|
26 Participants
|
28 Participants
|
|
Physical Examination - by Treatment Week - Cardiovascular
Infusion 6 (Visit 7 - Week 20) · Abnormal
|
1 Participants
|
1 Participants
|
|
Physical Examination - by Treatment Week - Cardiovascular
End of Study (Visit 8 - Week 52) · Normal
|
20 Participants
|
27 Participants
|
|
Physical Examination - by Treatment Week - Cardiovascular
End of Study (Visit 8 - Week 52) · Abnormal
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Physical examination - by treatment week - Summary - Safety analysis set - Head, Eyes, Ears, Nose, and Throat
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Physical Examination - by Treatment Week - HEENT
Baseline (Visit 2 - Week 1) · Normal
|
30 Participants
|
29 Participants
|
|
Physical Examination - by Treatment Week - HEENT
Baseline (Visit 2 - Week 1) · Abnormal
|
0 Participants
|
1 Participants
|
|
Physical Examination - by Treatment Week - HEENT
Infusion 2 (Visit 3 - Week 4) · Normal
|
30 Participants
|
29 Participants
|
|
Physical Examination - by Treatment Week - HEENT
Infusion 2 (Visit 3 - Week 4) · Abnormal
|
0 Participants
|
1 Participants
|
|
Physical Examination - by Treatment Week - HEENT
Infusion 3 (Visit 4 - Week 8) · Normal
|
28 Participants
|
29 Participants
|
|
Physical Examination - by Treatment Week - HEENT
Infusion 3 (Visit 4 - Week 8) · Abnormal
|
0 Participants
|
1 Participants
|
|
Physical Examination - by Treatment Week - HEENT
Infusion 4 (Visit 5 - Week 12) · Normal
|
28 Participants
|
29 Participants
|
|
Physical Examination - by Treatment Week - HEENT
Infusion 4 (Visit 5 - Week 12) · Abnormal
|
0 Participants
|
1 Participants
|
|
Physical Examination - by Treatment Week - HEENT
Infusion 5 (Visit 6 - Week 16) · Normal
|
27 Participants
|
28 Participants
|
|
Physical Examination - by Treatment Week - HEENT
Infusion 5 (Visit 6 - Week 16) · Abnormal
|
0 Participants
|
2 Participants
|
|
Physical Examination - by Treatment Week - HEENT
Infusion 6 (Visit 7 - Week 20) · Normal
|
27 Participants
|
28 Participants
|
|
Physical Examination - by Treatment Week - HEENT
Infusion 6 (Visit 7 - Week 20) · Abnormal
|
0 Participants
|
1 Participants
|
|
Physical Examination - by Treatment Week - HEENT
End of Study (Visit 8 - Week 52) · Normal
|
21 Participants
|
27 Participants
|
|
Physical Examination - by Treatment Week - HEENT
End of Study (Visit 8 - Week 52) · Abnormal
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Physical examination - by treatment week - Summary - Safety analysis set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Physical Examination - by Treatment Week - Lymph Node
Baseline (Visit 2 - Week 1) · Normal
|
30 Participants
|
30 Participants
|
|
Physical Examination - by Treatment Week - Lymph Node
Baseline (Visit 2 - Week 1) · Abnormal
|
0 Participants
|
0 Participants
|
|
Physical Examination - by Treatment Week - Lymph Node
Infusion 2 (Visit 3 - Week 4) · Normal
|
30 Participants
|
30 Participants
|
|
Physical Examination - by Treatment Week - Lymph Node
Infusion 2 (Visit 3 - Week 4) · Abnormal
|
0 Participants
|
0 Participants
|
|
Physical Examination - by Treatment Week - Lymph Node
Infusion 3 (Visit 4 - Week 8) · Normal
|
28 Participants
|
30 Participants
|
|
Physical Examination - by Treatment Week - Lymph Node
Infusion 3 (Visit 4 - Week 8) · Abnormal
|
0 Participants
|
0 Participants
|
|
Physical Examination - by Treatment Week - Lymph Node
Infusion 4 (Visit 5 - Week 12) · Normal
|
28 Participants
|
30 Participants
|
|
Physical Examination - by Treatment Week - Lymph Node
Infusion 4 (Visit 5 - Week 12) · Abnormal
|
0 Participants
|
0 Participants
|
|
Physical Examination - by Treatment Week - Lymph Node
Infusion 5 (Visit 6 - Week 16) · Normal
|
27 Participants
|
30 Participants
|
|
Physical Examination - by Treatment Week - Lymph Node
Infusion 5 (Visit 6 - Week 16) · Abnormal
|
0 Participants
|
0 Participants
|
|
Physical Examination - by Treatment Week - Lymph Node
Infusion 6 (Visit 7 - Week 20) · Normal
|
27 Participants
|
29 Participants
|
|
Physical Examination - by Treatment Week - Lymph Node
Infusion 6 (Visit 7 - Week 20) · Abnormal
|
0 Participants
|
0 Participants
|
|
Physical Examination - by Treatment Week - Lymph Node
End of Study (Visit 8 - Week 52) · Normal
|
21 Participants
|
28 Participants
|
|
Physical Examination - by Treatment Week - Lymph Node
End of Study (Visit 8 - Week 52) · Abnormal
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Physical examination - by treatment week - Summary - Safety analysis set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Physical Examination - by Treatment Week - Musculoskeletal
Baseline (Visit 2 - Week 1) · Normal
|
5 Participants
|
3 Participants
|
|
Physical Examination - by Treatment Week - Musculoskeletal
Baseline (Visit 2 - Week 1) · Abnormal
|
25 Participants
|
27 Participants
|
|
Physical Examination - by Treatment Week - Musculoskeletal
Infusion 2 (Visit 3 - Week 4) · Normal
|
6 Participants
|
4 Participants
|
|
Physical Examination - by Treatment Week - Musculoskeletal
Infusion 2 (Visit 3 - Week 4) · Abnormal
|
24 Participants
|
26 Participants
|
|
Physical Examination - by Treatment Week - Musculoskeletal
Infusion 3 (Visit 4 - Week 8) · Normal
|
5 Participants
|
5 Participants
|
|
Physical Examination - by Treatment Week - Musculoskeletal
Infusion 3 (Visit 4 - Week 8) · Abnormal
|
23 Participants
|
25 Participants
|
|
Physical Examination - by Treatment Week - Musculoskeletal
Infusion 4 (Visit 5 - Week 12) · Normal
|
4 Participants
|
4 Participants
|
|
Physical Examination - by Treatment Week - Musculoskeletal
Infusion 4 (Visit 5 - Week 12) · Abnormal
|
24 Participants
|
26 Participants
|
|
Physical Examination - by Treatment Week - Musculoskeletal
Infusion 5 (Visit 6 - Week 16) · Normal
|
4 Participants
|
5 Participants
|
|
Physical Examination - by Treatment Week - Musculoskeletal
Infusion 5 (Visit 6 - Week 16) · Abnormal
|
23 Participants
|
25 Participants
|
|
Physical Examination - by Treatment Week - Musculoskeletal
Infusion 6 (Visit 7 - Week 20) · Normal
|
2 Participants
|
3 Participants
|
|
Physical Examination - by Treatment Week - Musculoskeletal
Infusion 6 (Visit 7 - Week 20) · Abnormal
|
25 Participants
|
26 Participants
|
|
Physical Examination - by Treatment Week - Musculoskeletal
End of Study (Visit 8 - Week 52) · Normal
|
1 Participants
|
4 Participants
|
|
Physical Examination - by Treatment Week - Musculoskeletal
End of Study (Visit 8 - Week 52) · Abnormal
|
20 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Physical examination - by treatment week - Summary - Safety analysis set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Physical Examination - by Treatment Week - Neurological
Baseline (Visit 2 - Week 1) · Normal
|
5 Participants
|
4 Participants
|
|
Physical Examination - by Treatment Week - Neurological
Baseline (Visit 2 - Week 1) · Abnormal
|
25 Participants
|
26 Participants
|
|
Physical Examination - by Treatment Week - Neurological
Infusion 2 (Visit 3 - Week 4) · Normal
|
5 Participants
|
2 Participants
|
|
Physical Examination - by Treatment Week - Neurological
Infusion 2 (Visit 3 - Week 4) · Abnormal
|
25 Participants
|
28 Participants
|
|
Physical Examination - by Treatment Week - Neurological
Infusion 3 (Visit 4 - Week 8) · Normal
|
4 Participants
|
3 Participants
|
|
Physical Examination - by Treatment Week - Neurological
Infusion 3 (Visit 4 - Week 8) · Abnormal
|
24 Participants
|
27 Participants
|
|
Physical Examination - by Treatment Week - Neurological
Infusion 4 (Visit 5 - Week 12) · Normal
|
4 Participants
|
3 Participants
|
|
Physical Examination - by Treatment Week - Neurological
Infusion 4 (Visit 5 - Week 12) · Abnormal
|
24 Participants
|
27 Participants
|
|
Physical Examination - by Treatment Week - Neurological
Infusion 5 (Visit 6 - Week 16) · Normal
|
4 Participants
|
1 Participants
|
|
Physical Examination - by Treatment Week - Neurological
Infusion 5 (Visit 6 - Week 16) · Abnormal
|
23 Participants
|
29 Participants
|
|
Physical Examination - by Treatment Week - Neurological
Infusion 6 (Visit 7 - Week 20) · Normal
|
4 Participants
|
3 Participants
|
|
Physical Examination - by Treatment Week - Neurological
Infusion 6 (Visit 7 - Week 20) · Abnormal
|
23 Participants
|
26 Participants
|
|
Physical Examination - by Treatment Week - Neurological
End of Study (Visit 8 - Week 52) · Normal
|
3 Participants
|
5 Participants
|
|
Physical Examination - by Treatment Week - Neurological
End of Study (Visit 8 - Week 52) · Abnormal
|
18 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Physical examination - by treatment week - Summary - Safety analysis set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Physical Examination - by Treatment Week - Respiratory
Baseline (Visit 2 - Week 1) · Normal
|
30 Participants
|
29 Participants
|
|
Physical Examination - by Treatment Week - Respiratory
Baseline (Visit 2 - Week 1) · Abnormal
|
0 Participants
|
1 Participants
|
|
Physical Examination - by Treatment Week - Respiratory
Infusion 2 (Visit 3 - Week 4) · Normal
|
30 Participants
|
30 Participants
|
|
Physical Examination - by Treatment Week - Respiratory
Infusion 2 (Visit 3 - Week 4) · Abnormal
|
0 Participants
|
0 Participants
|
|
Physical Examination - by Treatment Week - Respiratory
Infusion 3 (Visit 4 - Week 8) · Normal
|
28 Participants
|
30 Participants
|
|
Physical Examination - by Treatment Week - Respiratory
Infusion 3 (Visit 4 - Week 8) · Abnormal
|
0 Participants
|
0 Participants
|
|
Physical Examination - by Treatment Week - Respiratory
Infusion 4 (Visit 5 - Week 12) · Normal
|
28 Participants
|
29 Participants
|
|
Physical Examination - by Treatment Week - Respiratory
Infusion 4 (Visit 5 - Week 12) · Abnormal
|
0 Participants
|
1 Participants
|
|
Physical Examination - by Treatment Week - Respiratory
Infusion 5 (Visit 6 - Week 16) · Normal
|
27 Participants
|
29 Participants
|
|
Physical Examination - by Treatment Week - Respiratory
Infusion 5 (Visit 6 - Week 16) · Abnormal
|
0 Participants
|
1 Participants
|
|
Physical Examination - by Treatment Week - Respiratory
Infusion 6 (Visit 7 - Week 20) · Normal
|
27 Participants
|
28 Participants
|
|
Physical Examination - by Treatment Week - Respiratory
Infusion 6 (Visit 7 - Week 20) · Abnormal
|
0 Participants
|
1 Participants
|
|
Physical Examination - by Treatment Week - Respiratory
End of Study (Visit 8 - Week 52) · Normal
|
21 Participants
|
27 Participants
|
|
Physical Examination - by Treatment Week - Respiratory
End of Study (Visit 8 - Week 52) · Abnormal
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to Weeks 52Population: The total number of enrolled participants in this study (the safety analysis set) is 30 placebo participants and 30 treatment participants. Some subjects either withdrew or were lost to follow-up before End of Study, causing slight variation of subject population at that visit.
Physical examination - by treatment week - Summary - Safety analysis set
Outcome measures
| Measure |
Placebo
n=30 Participants
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
Allogeneic HB-adMSCs.
n=30 Participants
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
|---|---|---|
|
Physical Examination - by Treatment Week - Skin
Baseline (Visit 2 - Week 1) · Normal
|
30 Participants
|
30 Participants
|
|
Physical Examination - by Treatment Week - Skin
Baseline (Visit 2 - Week 1) · Abnormal
|
0 Participants
|
0 Participants
|
|
Physical Examination - by Treatment Week - Skin
Infusion 2 (Visit 3 - Week 4) · Normal
|
30 Participants
|
30 Participants
|
|
Physical Examination - by Treatment Week - Skin
Infusion 2 (Visit 3 - Week 4) · Abnormal
|
0 Participants
|
0 Participants
|
|
Physical Examination - by Treatment Week - Skin
Infusion 3 (Visit 4 - Week 8) · Normal
|
28 Participants
|
30 Participants
|
|
Physical Examination - by Treatment Week - Skin
Infusion 3 (Visit 4 - Week 8) · Abnormal
|
0 Participants
|
0 Participants
|
|
Physical Examination - by Treatment Week - Skin
Infusion 4 (Visit 5 - Week 12) · Normal
|
28 Participants
|
30 Participants
|
|
Physical Examination - by Treatment Week - Skin
Infusion 4 (Visit 5 - Week 12) · Abnormal
|
0 Participants
|
0 Participants
|
|
Physical Examination - by Treatment Week - Skin
Infusion 5 (Visit 6 - Week 16) · Normal
|
27 Participants
|
30 Participants
|
|
Physical Examination - by Treatment Week - Skin
Infusion 5 (Visit 6 - Week 16) · Abnormal
|
0 Participants
|
0 Participants
|
|
Physical Examination - by Treatment Week - Skin
Infusion 6 (Visit 7 - Week 20) · Normal
|
27 Participants
|
29 Participants
|
|
Physical Examination - by Treatment Week - Skin
Infusion 6 (Visit 7 - Week 20) · Abnormal
|
0 Participants
|
0 Participants
|
|
Physical Examination - by Treatment Week - Skin
End of Study (Visit 8 - Week 52) · Normal
|
20 Participants
|
28 Participants
|
|
Physical Examination - by Treatment Week - Skin
End of Study (Visit 8 - Week 52) · Abnormal
|
1 Participants
|
0 Participants
|
Adverse Events
Allogeneic HB-adMSCs.
Placebo
Serious adverse events
| Measure |
Allogeneic HB-adMSCs.
n=30 participants at risk
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
Placebo
n=30 participants at risk
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
|---|---|---|
|
General disorders
Chest Pain
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
Other adverse events
| Measure |
Allogeneic HB-adMSCs.
n=30 participants at risk
Biological/Vaccine: Allogeneic HB-adMSCs
Allogeneic HB-adMSCs will be administered intravenously to study participants who qualify.
Other Names: Allogeneic Hope Biosciences adipose derived mesenchymal stem cells.
|
Placebo
n=30 participants at risk
Placebo will be administered intravenously to study participants who qualify.
Other Names: Sterile Saline Solution 0.9%
|
|---|---|---|
|
Nervous system disorders
Headache
|
33.3%
10/30 • Number of events 21 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
13.3%
4/30 • Number of events 10 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Nervous system disorders
Tremor
|
6.7%
2/30 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
16.7%
5/30 • Number of events 5 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Nervous system disorders
Dyskinesia
|
13.3%
4/30 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Nervous system disorders
Balance disorder
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
6.7%
2/30 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Nervous system disorders
Bradykinesia
|
6.7%
2/30 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Nervous system disorders
Dizziness
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
6.7%
2/30 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Nervous system disorders
Dystonia
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
10.0%
3/30 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Nervous system disorders
Freezing phenomenon
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
6.7%
2/30 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
6.7%
2/30 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Nervous system disorders
Somnolence
|
3.3%
1/30 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
3.3%
1/30 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Nervous system disorders
Fine motor skill dysfunction
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Nervous system disorders
Movement disorder
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Nervous system disorders
Speech disorder
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
General disorders
Fatigue
|
6.7%
2/30 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
10.0%
3/30 • Number of events 5 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
General disorders
Influenza like illness
|
3.3%
1/30 • Number of events 4 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
6.7%
2/30 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
General disorders
Asthenia
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
6.7%
2/30 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
General disorders
Gait disturbance
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
General disorders
Chest pain
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
General disorders
Chills
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
General disorders
Drug ineffective
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
General disorders
Peripheral swelling
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Infections and infestations
COVID-19
|
16.7%
5/30 • Number of events 5 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
10.0%
3/30 • Number of events 3 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
6.7%
2/30 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
6.7%
2/30 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
2/30 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Injury, poisoning and procedural complications
Eye contusion
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
3.3%
1/30 • Number of events 2 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Psychiatric disorders
Confusional state
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Psychiatric disorders
Hallucination, auditory
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Psychiatric disorders
Insomnia
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Surgical and medical procedures
Cataract operation
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Surgical and medical procedures
Hernia repair
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Surgical and medical procedures
Knee operation
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Eye disorders
Vision blurred
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Investigations
Prostate specific antigen increased
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Renal and urinary disorders
Incontinence
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
|
Vascular disorders
Hypertension
|
0.00%
0/30 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
3.3%
1/30 • Number of events 1 • Treatment Emergent Adverse Events (TEAEs) were monitored from Week 0 (Infusion 1) through Week 24 (Follow-Up 1). A treatment emergent adverse event (TEAE) is defined as an event that has onset date on or after the first day of exposure to infusion treatment and on or before the first safety follow-up (week 24).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place