Trial Outcomes & Findings for Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy for Idiopathic Parkinson's Disease (NCT NCT04506073)
NCT ID: NCT04506073
Last Updated: 2026-09-02
Results Overview
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III assesses motor symptoms of Parkinson's disease. . A responder was defined as a participant achieving a ≥5-point improvement (decrease of at least 5 points from screening) at Week 62. Reported are the Bayesian mean estimates of the proportion of participants achieving this response. The 95% confidence interval represents the Bayesian 95% credible interval.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
45 participants
Primary outcome timeframe
From Baseline to Week 62
Results posted on
2026-09-02
Participant Flow
Participant milestones
| Measure |
Mesenchymal Stem Cells
3 infusions of 10 X 10\^6 MSC/kg administered every 4 months.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
|
Mesenchymal Stem Cells and Placebo
2 infusions of 10 X 10\^6 MSC/kg and 1 placebo infusion, all doses administered 4 months apart.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
Placebo
3 placebo doses administered every 4 months.
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
|---|---|---|---|
|
Overall Study
STARTED
|
16
|
14
|
15
|
|
Overall Study
COMPLETED
|
16
|
13
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase IIa Randomized Placebo Controlled Trial: Mesenchymal Stem Cells as a Disease-modifying Therapy for Idiopathic Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Mesenchymal Stem Cells
n=16 Participants
3 infusions of 10 X 10\^6 MSC/kg administered every 4 months.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
|
Mesenchymal Stem Cells and Placebo
n=14 Participants
2 infusions of 10 X 10\^6 MSC/kg and 1 placebo infusion, all doses administered 4 months apart.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
Placebo
n=15 Participants
3 placebo doses administered every 4 months.
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64.3 years
STANDARD_DEVIATION 8.55 • n=136 Participants
|
68.6 years
STANDARD_DEVIATION 6.19 • n=136 Participants
|
66.9 years
STANDARD_DEVIATION 6.43 • n=272 Participants
|
66.5 years
STANDARD_DEVIATION 7.25 • n=60 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=136 Participants
|
3 Participants
n=136 Participants
|
3 Participants
n=272 Participants
|
10 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=136 Participants
|
11 Participants
n=136 Participants
|
12 Participants
n=272 Participants
|
35 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=136 Participants
|
12 Participants
n=136 Participants
|
13 Participants
n=272 Participants
|
35 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=136 Participants
|
2 Participants
n=136 Participants
|
2 Participants
n=272 Participants
|
10 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=272 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=136 Participants
|
14 Participants
n=136 Participants
|
14 Participants
n=272 Participants
|
44 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=136 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=272 Participants
|
0 Participants
n=60 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=136 Participants
|
14 participants
n=136 Participants
|
15 participants
n=272 Participants
|
45 participants
n=60 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Week 62The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III assesses motor symptoms of Parkinson's disease. . A responder was defined as a participant achieving a ≥5-point improvement (decrease of at least 5 points from screening) at Week 62. Reported are the Bayesian mean estimates of the proportion of participants achieving this response. The 95% confidence interval represents the Bayesian 95% credible interval.
Outcome measures
| Measure |
Mesenchymal Stem Cells
n=16 Participants
3 infusions of 10 X 10\^6 MSC/kg administered every 4 months.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
|
Mesenchymal Stem Cells and Placebo
n=13 Participants
2 infusions of 10 X 10\^6 MSC/kg and 1 placebo infusion, all doses administered 4 months apart.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
Placebo
n=13 Participants
3 placebo doses administered every 4 months.
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
|---|---|---|---|
|
Bayesian Mean Estimate of the Proportion of Participants Achieving a ≥5-point Improvement on MDS-UPDRS Part III From Screening to Week 62, Compared Between Each Active MSC Dose Arm and Placebo
|
99.9 percentage of participants
Interval 93.6 to 99.9
|
30 percentage of participants
Interval 10.0 to 57.1
|
94.4 percentage of participants
Interval 74.7 to 99.7
|
SECONDARY outcome
Timeframe: Baseline through week 88New-onset organ failure defined as a significant acute change in the kidney or liver function, leukocytosis, leukopenia or anemia sustained over 3 months; \> 75 % reduction in GFR compared to baseline; altered liver function as defined by ALT \>150 U/L and or total bilirubin \>1.6 mg/dl; or leukopenia defined as \< 4K WBC count or anemia as defined by Hgb \< 12 for men and \< 11 for women.
Outcome measures
| Measure |
Mesenchymal Stem Cells
n=16 Participants
3 infusions of 10 X 10\^6 MSC/kg administered every 4 months.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
|
Mesenchymal Stem Cells and Placebo
n=14 Participants
2 infusions of 10 X 10\^6 MSC/kg and 1 placebo infusion, all doses administered 4 months apart.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
Placebo
n=15 Participants
3 placebo doses administered every 4 months.
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
|---|---|---|---|
|
Number of Participants With New-onset Organ Failure
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline through week 88Outcome measures
| Measure |
Mesenchymal Stem Cells
n=16 Participants
3 infusions of 10 X 10\^6 MSC/kg administered every 4 months.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
|
Mesenchymal Stem Cells and Placebo
n=14 Participants
2 infusions of 10 X 10\^6 MSC/kg and 1 placebo infusion, all doses administered 4 months apart.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
Placebo
n=15 Participants
3 placebo doses administered every 4 months.
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
|---|---|---|---|
|
Number of Participants Developing Donor-Specific Anti-HLA Antibodies
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88Population: Data were collected from all participants who completed the assessment at each time point.
This test uses the time that a person takes to rise from a chair, walk 7 meters, turn around, walk back to the chair, and sit down. Time is recorded in seconds, a longer duration of time indicates a worse outcome.
Outcome measures
| Measure |
Mesenchymal Stem Cells
n=16 Participants
3 infusions of 10 X 10\^6 MSC/kg administered every 4 months.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
|
Mesenchymal Stem Cells and Placebo
n=14 Participants
2 infusions of 10 X 10\^6 MSC/kg and 1 placebo infusion, all doses administered 4 months apart.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
Placebo
n=15 Participants
3 placebo doses administered every 4 months.
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
|---|---|---|---|
|
Motor Function as Measured by the Timed-Up-and-Go (TUG) Scale
Week 9
|
15.88 seconds
Standard Deviation 2.98
|
15.53 seconds
Standard Deviation 2.16
|
16.94 seconds
Standard Deviation 3.08
|
|
Motor Function as Measured by the Timed-Up-and-Go (TUG) Scale
Week 88
|
14.79 seconds
Standard Deviation 4.47
|
13.84 seconds
Standard Deviation 2.34
|
15.79 seconds
Standard Deviation 4.51
|
|
Motor Function as Measured by the Timed-Up-and-Go (TUG) Scale
Baseline
|
18.23 seconds
Standard Deviation 4.1
|
17.08 seconds
Standard Deviation 2.52
|
17.88 seconds
Standard Deviation 3
|
|
Motor Function as Measured by the Timed-Up-and-Go (TUG) Scale
Week 27
|
15.38 seconds
Standard Deviation 3.38
|
14.51 seconds
Standard Deviation 2.09
|
15.50 seconds
Standard Deviation 3.76
|
|
Motor Function as Measured by the Timed-Up-and-Go (TUG) Scale
Week 40
|
14.54 seconds
Standard Deviation 3.29
|
15.32 seconds
Standard Deviation 3.4
|
15.65 seconds
Standard Deviation 4.55
|
|
Motor Function as Measured by the Timed-Up-and-Go (TUG) Scale
Week 62
|
15.29 seconds
Standard Deviation 3.9
|
13.96 seconds
Standard Deviation 2.19
|
16.38 seconds
Standard Deviation 4.54
|
SECONDARY outcome
Timeframe: BaselineThe Columbia-Suicide Severity Rating Scale (C-SSRS) is an assessment tool that evaluates suicidal ideation and behavior. Reported is the number of participants with a positive response to the lifetime suicidal ideation question, "Have you actually had any thoughts of killing yourself?"
Outcome measures
| Measure |
Mesenchymal Stem Cells
n=16 Participants
3 infusions of 10 X 10\^6 MSC/kg administered every 4 months.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
|
Mesenchymal Stem Cells and Placebo
n=14 Participants
2 infusions of 10 X 10\^6 MSC/kg and 1 placebo infusion, all doses administered 4 months apart.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
Placebo
n=15 Participants
3 placebo doses administered every 4 months.
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
|---|---|---|---|
|
Number of Participants With Lifetime Suicidal Ideation (C-SSRS)
|
3 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88Population: Data were collected from all participants who completed the assessment at each time point
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) assesses the severity of Parkinson's disease. The total score ranges from 0 to 265, with higher scores indicating greater Parkinson's disease severity and disability.
Outcome measures
| Measure |
Mesenchymal Stem Cells
n=16 Participants
3 infusions of 10 X 10\^6 MSC/kg administered every 4 months.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
|
Mesenchymal Stem Cells and Placebo
n=14 Participants
2 infusions of 10 X 10\^6 MSC/kg and 1 placebo infusion, all doses administered 4 months apart.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
Placebo
n=15 Participants
3 placebo doses administered every 4 months.
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
|---|---|---|---|
|
Parkinson's Disease Severity as Assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score
Baseline
|
66.06 score on a scale
Standard Deviation 13.29
|
62.93 score on a scale
Standard Deviation 22.09
|
65.93 score on a scale
Standard Deviation 23.21
|
|
Parkinson's Disease Severity as Assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score
Week 9
|
45.06 score on a scale
Standard Deviation 10.1
|
58.79 score on a scale
Standard Deviation 20.19
|
57.71 score on a scale
Standard Deviation 19.97
|
|
Parkinson's Disease Severity as Assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score
Week 27
|
41.13 score on a scale
Standard Deviation 11.56
|
57.14 score on a scale
Standard Deviation 17.66
|
49.36 score on a scale
Standard Deviation 20.19
|
|
Parkinson's Disease Severity as Assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score
Week 40
|
40.31 score on a scale
Standard Deviation 13.97
|
55.69 score on a scale
Standard Deviation 18.33
|
44.57 score on a scale
Standard Deviation 23.36
|
|
Parkinson's Disease Severity as Assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score
Week 62
|
38.94 score on a scale
Standard Deviation 14.42
|
56.85 score on a scale
Standard Deviation 20.73
|
37.69 score on a scale
Standard Deviation 16.21
|
|
Parkinson's Disease Severity as Assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Total Score
Week 88
|
40.19 score on a scale
Standard Deviation 12.3
|
57.15 score on a scale
Standard Deviation 19.73
|
39.36 score on a scale
Standard Deviation 17.93
|
SECONDARY outcome
Timeframe: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88Population: Data was collected from participants who attended the visit and completed the assessment at each time point.
The Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Motor Examination assesses motor symptoms of Parkinson's disease. The total score ranges from 0 to 132, with higher scores indicating greater motor impairment and more severe Parkinson's disease motor symptoms.
Outcome measures
| Measure |
Mesenchymal Stem Cells
n=16 Participants
3 infusions of 10 X 10\^6 MSC/kg administered every 4 months.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
|
Mesenchymal Stem Cells and Placebo
n=14 Participants
2 infusions of 10 X 10\^6 MSC/kg and 1 placebo infusion, all doses administered 4 months apart.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
Placebo
n=15 Participants
3 placebo doses administered every 4 months.
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
|---|---|---|---|
|
Motor Symptoms of Parkinson's Disease as Assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Motor Examination Score
Week 40
|
21.13 score on a scale
Standard Deviation 9.27
|
33.08 score on a scale
Standard Deviation 8.35
|
22.36 score on a scale
Standard Deviation 14.53
|
|
Motor Symptoms of Parkinson's Disease as Assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Motor Examination Score
Week 62
|
19.5 score on a scale
Standard Deviation 9.71
|
32.92 score on a scale
Standard Deviation 8.37
|
18.31 score on a scale
Standard Deviation 10.63
|
|
Motor Symptoms of Parkinson's Disease as Assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Motor Examination Score
Week 88
|
20.81 score on a scale
Standard Deviation 8.26
|
33.62 score on a scale
Standard Deviation 9.47
|
20.36 score on a scale
Standard Deviation 11.30
|
|
Motor Symptoms of Parkinson's Disease as Assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Motor Examination Score
Baseline
|
37.13 score on a scale
Standard Deviation 9.93
|
36.57 score on a scale
Standard Deviation 9.04
|
35.33 score on a scale
Standard Deviation 11.13
|
|
Motor Symptoms of Parkinson's Disease as Assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Motor Examination Score
Week 9
|
23.69 score on a scale
Standard Deviation 7.12
|
34.93 score on a scale
Standard Deviation 9.03
|
32.86 score on a scale
Standard Deviation 11.44
|
|
Motor Symptoms of Parkinson's Disease as Assessed by the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Motor Examination Score
Week 27
|
22.13 score on a scale
Standard Deviation 7.86
|
34.29 score on a scale
Standard Deviation 8.56
|
25.79 score on a scale
Standard Deviation 12.49
|
SECONDARY outcome
Timeframe: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88Population: Data was collected from participants who attended the visit and completed the assessment at each time point.
The Modified Hoehn and Yahr (H\&Y) Scale described the progress of Parkinson's disease. Total score ranges from 0 to 5, with higher scores indicating a worse outcome. The assessment was performed in the "off" medication state, and the score will be reported.
Outcome measures
| Measure |
Mesenchymal Stem Cells
n=16 Participants
3 infusions of 10 X 10\^6 MSC/kg administered every 4 months.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
|
Mesenchymal Stem Cells and Placebo
n=14 Participants
2 infusions of 10 X 10\^6 MSC/kg and 1 placebo infusion, all doses administered 4 months apart.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
Placebo
n=15 Participants
3 placebo doses administered every 4 months.
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
|---|---|---|---|
|
Global Measurement of Disability as Measured by the Change in the Screening "Off" Modified Hoehn and Yahr (H&Y)
Baseline
|
2.16 score on a scale
Standard Deviation 0.3
|
2.04 score on a scale
Standard Deviation 0.37
|
2.2 score on a scale
Standard Deviation 0.46
|
|
Global Measurement of Disability as Measured by the Change in the Screening "Off" Modified Hoehn and Yahr (H&Y)
Week 9
|
1.97 score on a scale
Standard Deviation 0.22
|
2.07 score on a scale
Standard Deviation 0.27
|
2.07 score on a scale
Standard Deviation 0.39
|
|
Global Measurement of Disability as Measured by the Change in the Screening "Off" Modified Hoehn and Yahr (H&Y)
Week 27
|
1.94 score on a scale
Standard Deviation 0.25
|
2.07 score on a scale
Standard Deviation 0.27
|
2.00 score on a scale
Standard Deviation 0.34
|
|
Global Measurement of Disability as Measured by the Change in the Screening "Off" Modified Hoehn and Yahr (H&Y)
Week 40
|
1.94 score on a scale
Standard Deviation 0.25
|
2.08 score on a scale
Standard Deviation 0.28
|
2.00 score on a scale
Standard Deviation 0.44
|
|
Global Measurement of Disability as Measured by the Change in the Screening "Off" Modified Hoehn and Yahr (H&Y)
Week 62
|
1.97 score on a scale
Standard Deviation 0.34
|
2.08 score on a scale
Standard Deviation 0.28
|
1.96 score on a scale
Standard Deviation 0.43
|
|
Global Measurement of Disability as Measured by the Change in the Screening "Off" Modified Hoehn and Yahr (H&Y)
Week 88
|
1.94 score on a scale
Standard Deviation 0.25
|
2.08 score on a scale
Standard Deviation 0.28
|
2.00 score on a scale
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88Population: Data was collected from participants who attended the visit and completed the assessment at each time point.
The Schwab and England Activities of Daily Living (ADL) Scale assesses functional independence in individuals with Parkinson's disease. Scores range from 0% to 100%, with higher percentages indicating greater independence and better functional ability in activities of daily living.
Outcome measures
| Measure |
Mesenchymal Stem Cells
n=16 Participants
3 infusions of 10 X 10\^6 MSC/kg administered every 4 months.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
|
Mesenchymal Stem Cells and Placebo
n=14 Participants
2 infusions of 10 X 10\^6 MSC/kg and 1 placebo infusion, all doses administered 4 months apart.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
Placebo
n=15 Participants
3 placebo doses administered every 4 months.
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
|---|---|---|---|
|
Quality of Life as Measured by the Modified Schwab and England Activities of Daily Living Scale (ADL)
Baseline
|
87.5 percentage
Standard Deviation 10
|
90.71 percentage
Standard Deviation 9.17
|
86 percentage
Standard Deviation 9.86
|
|
Quality of Life as Measured by the Modified Schwab and England Activities of Daily Living Scale (ADL)
Week 9
|
91.88 percentage
Standard Deviation 6.55
|
89.29 percentage
Standard Deviation 8.29
|
90.71 percentage
Standard Deviation 7.30
|
|
Quality of Life as Measured by the Modified Schwab and England Activities of Daily Living Scale (ADL)
Week 27
|
96.25 percentage
Standard Deviation 6.19
|
91.43 percentage
Standard Deviation 6.63
|
92.14 percentage
Standard Deviation 8.93
|
|
Quality of Life as Measured by the Modified Schwab and England Activities of Daily Living Scale (ADL)
Week 40
|
97.50 percentage
Standard Deviation 5.77
|
93.08 percentage
Standard Deviation 8.55
|
92.14 percentage
Standard Deviation 9.75
|
|
Quality of Life as Measured by the Modified Schwab and England Activities of Daily Living Scale (ADL)
Week 62
|
95 percentage
Standard Deviation 8.16
|
94.62 percentage
Standard Deviation 6.60
|
90.77 percentage
Standard Deviation 11.88
|
|
Quality of Life as Measured by the Modified Schwab and England Activities of Daily Living Scale (ADL)
Week 88
|
96.88 percentage
Standard Deviation 6.02
|
93.08 percentage
Standard Deviation 11.82
|
92.73 percentage
Standard Deviation 11.91
|
SECONDARY outcome
Timeframe: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88Population: Data was collected from participants who attended the visit and completed the assessment at each time point.
The Parkinson's Disease Questionnaire-39 (PDQ-39) assesses health-related quality of life in individuals with Parkinson's disease. Total scores range from 0 to 100, with higher scores indicating poorer quality of life.
Outcome measures
| Measure |
Mesenchymal Stem Cells
n=16 Participants
3 infusions of 10 X 10\^6 MSC/kg administered every 4 months.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
|
Mesenchymal Stem Cells and Placebo
n=14 Participants
2 infusions of 10 X 10\^6 MSC/kg and 1 placebo infusion, all doses administered 4 months apart.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
Placebo
n=15 Participants
3 placebo doses administered every 4 months.
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
|---|---|---|---|
|
Quality of Life as Measured by the Parkinson's Disease Questionnaire-39 (PDQ-39)
Week 62
|
21.5 score on a scale
Standard Deviation 14.31
|
15.85 score on a scale
Standard Deviation 9.77
|
20.77 score on a scale
Standard Deviation 18.02
|
|
Quality of Life as Measured by the Parkinson's Disease Questionnaire-39 (PDQ-39)
Baseline
|
24.75 score on a scale
Standard Deviation 13.45
|
14.07 score on a scale
Standard Deviation 8.77
|
19.4 score on a scale
Standard Deviation 14.67
|
|
Quality of Life as Measured by the Parkinson's Disease Questionnaire-39 (PDQ-39)
Week 9
|
20.69 score on a scale
Standard Deviation 14.53
|
14.43 score on a scale
Standard Deviation 10.75
|
17.93 score on a scale
Standard Deviation 17.86
|
|
Quality of Life as Measured by the Parkinson's Disease Questionnaire-39 (PDQ-39)
Week 27
|
21.06 score on a scale
Standard Deviation 11.98
|
14.07 score on a scale
Standard Deviation 8.71
|
19.50 score on a scale
Standard Deviation 18.50
|
|
Quality of Life as Measured by the Parkinson's Disease Questionnaire-39 (PDQ-39)
Week 40
|
19.94 score on a scale
Standard Deviation 12.77
|
13 score on a scale
Standard Deviation 6.67
|
19.43 score on a scale
Standard Deviation 17.08
|
|
Quality of Life as Measured by the Parkinson's Disease Questionnaire-39 (PDQ-39)
Week 88
|
24 score on a scale
Standard Deviation 14.36
|
17.85 score on a scale
Standard Deviation 9.62
|
21.82 score on a scale
Standard Deviation 16.52
|
SECONDARY outcome
Timeframe: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88Population: Data was collected from participants who attended the visit and completed the assessment at each time point.
The EuroQol- 5 Dimension (EQ-5D) assesses quality of life. The total score ranges between 0 to 1, a higher score indicating better quality of life.
Outcome measures
| Measure |
Mesenchymal Stem Cells
n=16 Participants
3 infusions of 10 X 10\^6 MSC/kg administered every 4 months.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
|
Mesenchymal Stem Cells and Placebo
n=14 Participants
2 infusions of 10 X 10\^6 MSC/kg and 1 placebo infusion, all doses administered 4 months apart.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
Placebo
n=15 Participants
3 placebo doses administered every 4 months.
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
|---|---|---|---|
|
Quality of Life as Measured by the EuroQol- 5 Dimension (EQ-5D) Index Score
Week 88
|
0.82 score on a scale
Standard Deviation 0.1
|
0.84 score on a scale
Standard Deviation 0.12
|
0.79 score on a scale
Standard Deviation 0.13
|
|
Quality of Life as Measured by the EuroQol- 5 Dimension (EQ-5D) Index Score
Baseline
|
0.8 score on a scale
Standard Deviation 0.08
|
0.83 score on a scale
Standard Deviation 0.12
|
0.79 score on a scale
Standard Deviation 0.11
|
|
Quality of Life as Measured by the EuroQol- 5 Dimension (EQ-5D) Index Score
Week 9
|
0.82 score on a scale
Standard Deviation 0.08
|
0.86 score on a scale
Standard Deviation 0.07
|
0.83 score on a scale
Standard Deviation 0.11
|
|
Quality of Life as Measured by the EuroQol- 5 Dimension (EQ-5D) Index Score
Week 27
|
0.82 score on a scale
Standard Deviation 0.06
|
0.85 score on a scale
Standard Deviation 0.11
|
0.8 score on a scale
Standard Deviation 0.11
|
|
Quality of Life as Measured by the EuroQol- 5 Dimension (EQ-5D) Index Score
Week 40
|
0.8 score on a scale
Standard Deviation 0.09
|
0.84 score on a scale
Standard Deviation 0.12
|
0.79 score on a scale
Standard Deviation 0.12
|
|
Quality of Life as Measured by the EuroQol- 5 Dimension (EQ-5D) Index Score
Week 62
|
0.81 score on a scale
Standard Deviation 0.05
|
0.87 score on a scale
Standard Deviation 0.12
|
0.8 score on a scale
Standard Deviation 0.12
|
SECONDARY outcome
Timeframe: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88Population: Data was collected from participants who attended the visit and completed the assessment.
The Non-Motor Symptoms Questionnaire (NMSQ) assesses the presence of non-motor symptoms associated with Parkinson's disease. Total score ranges from 0 to 30, with a higher score indicating a greater number of non-motor symptoms.
Outcome measures
| Measure |
Mesenchymal Stem Cells
n=16 Participants
3 infusions of 10 X 10\^6 MSC/kg administered every 4 months.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
|
Mesenchymal Stem Cells and Placebo
n=14 Participants
2 infusions of 10 X 10\^6 MSC/kg and 1 placebo infusion, all doses administered 4 months apart.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
Placebo
n=15 Participants
3 placebo doses administered every 4 months.
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
|---|---|---|---|
|
Non- Motor Symptoms as Measured by the Non-Motor Symptoms Questionnaire (NMSQ)
Baseline
|
7.19 score on a scale
Standard Deviation 3.67
|
7.14 score on a scale
Standard Deviation 3.9
|
8 score on a scale
Standard Deviation 3.59
|
|
Non- Motor Symptoms as Measured by the Non-Motor Symptoms Questionnaire (NMSQ)
Week 9
|
6.81 score on a scale
Standard Deviation 4.43
|
5.79 score on a scale
Standard Deviation 3.47
|
7.43 score on a scale
Standard Deviation 3.44
|
|
Non- Motor Symptoms as Measured by the Non-Motor Symptoms Questionnaire (NMSQ)
Week 27
|
7 score on a scale
Standard Deviation 4.53
|
6.36 score on a scale
Standard Deviation 3.79
|
7.43 score on a scale
Standard Deviation 3.48
|
|
Non- Motor Symptoms as Measured by the Non-Motor Symptoms Questionnaire (NMSQ)
Week 40
|
7.25 score on a scale
Standard Deviation 5.13
|
6.23 score on a scale
Standard Deviation 2.98
|
7.43 score on a scale
Standard Deviation 3.01
|
|
Non- Motor Symptoms as Measured by the Non-Motor Symptoms Questionnaire (NMSQ)
Week 62
|
7.69 score on a scale
Standard Deviation 4.53
|
7 score on a scale
Standard Deviation 3.79
|
7.85 score on a scale
Standard Deviation 3.39
|
|
Non- Motor Symptoms as Measured by the Non-Motor Symptoms Questionnaire (NMSQ)
Week 88
|
7.64 score on a scale
Standard Deviation 3.46
|
7.77 score on a scale
Standard Deviation 4.6
|
8.91 score on a scale
Standard Deviation 2.81
|
SECONDARY outcome
Timeframe: Baseline, Week 49, Week 88Population: Data was collected from participants who attended the visit and completed the assessment at each time point.
The University of Pennsylvania Smell Identification Test (UPSIT-40) assesses olfactory function. The total score ranges from 0 to 40 with a higher score indicating better olfactory function.
Outcome measures
| Measure |
Mesenchymal Stem Cells
n=16 Participants
3 infusions of 10 X 10\^6 MSC/kg administered every 4 months.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
|
Mesenchymal Stem Cells and Placebo
n=14 Participants
2 infusions of 10 X 10\^6 MSC/kg and 1 placebo infusion, all doses administered 4 months apart.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
Placebo
n=15 Participants
3 placebo doses administered every 4 months.
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
|---|---|---|---|
|
Olfactory Function as Assessed by the University of Pennsylvania Smell Identification Test (UPSIT-40) Score
Baseline
|
19.44 score on a scale
Standard Deviation 5.35
|
20.93 score on a scale
Standard Deviation 6.01
|
19.73 score on a scale
Standard Deviation 6.89
|
|
Olfactory Function as Assessed by the University of Pennsylvania Smell Identification Test (UPSIT-40) Score
Week 49
|
19.58 score on a scale
Standard Deviation 5.93
|
16.64 score on a scale
Standard Deviation 5.45
|
16.64 score on a scale
Standard Deviation 6.79
|
|
Olfactory Function as Assessed by the University of Pennsylvania Smell Identification Test (UPSIT-40) Score
Week 88
|
18.87 score on a scale
Standard Deviation 7.24
|
19.85 score on a scale
Standard Deviation 5.87
|
17.91 score on a scale
Standard Deviation 7.25
|
SECONDARY outcome
Timeframe: Baseline, Week 49, Week 88Population: Data was collected from participants who attended the visit and completed the assessment at each time point.
The Montreal Cognitive Assessment (MoCA) assesses cognitive function. The total score ranges from 0 to 30, a higher score indicates better cognitive function.
Outcome measures
| Measure |
Mesenchymal Stem Cells
n=16 Participants
3 infusions of 10 X 10\^6 MSC/kg administered every 4 months.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
|
Mesenchymal Stem Cells and Placebo
n=14 Participants
2 infusions of 10 X 10\^6 MSC/kg and 1 placebo infusion, all doses administered 4 months apart.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
Placebo
n=15 Participants
3 placebo doses administered every 4 months.
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
|---|---|---|---|
|
Cognitive Function as Measured by the Montreal Cognitive Assessment (MoCA)
Baseline
|
27.88 score on a scale
Standard Deviation 1.36
|
27.5 score on a scale
Standard Deviation 1.29
|
27.27 score on a scale
Standard Deviation 1.71
|
|
Cognitive Function as Measured by the Montreal Cognitive Assessment (MoCA)
Week 49
|
28.56 score on a scale
Standard Deviation 1.03
|
28.08 score on a scale
Standard Deviation 1.38
|
28.38 score on a scale
Standard Deviation 1.19
|
|
Cognitive Function as Measured by the Montreal Cognitive Assessment (MoCA)
Week 88
|
28.44 score on a scale
Standard Deviation 1.21
|
28.31 score on a scale
Standard Deviation 1.89
|
27.91 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88Population: Data was collected from participants who attended the visit and completed the assessment at each time point.
The Parkinson Anxiety Scale (PAS) assesses anxiety symptoms in individuals with Parkinson's disease. The total score ranges from 0 to 48, with higher scores indicating greater anxiety severity.
Outcome measures
| Measure |
Mesenchymal Stem Cells
n=16 Participants
3 infusions of 10 X 10\^6 MSC/kg administered every 4 months.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
|
Mesenchymal Stem Cells and Placebo
n=14 Participants
2 infusions of 10 X 10\^6 MSC/kg and 1 placebo infusion, all doses administered 4 months apart.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
Placebo
n=15 Participants
3 placebo doses administered every 4 months.
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
|---|---|---|---|
|
Anxiety as Assessed by the Parkinson Anxiety Scale (PAS) Score
Baseline
|
9.19 score on a scale
Standard Deviation 5.68
|
8.43 score on a scale
Standard Deviation 4.65
|
7 score on a scale
Standard Deviation 6.59
|
|
Anxiety as Assessed by the Parkinson Anxiety Scale (PAS) Score
Week 9
|
7.06 score on a scale
Standard Deviation 4.78
|
7.43 score on a scale
Standard Deviation 5
|
6.93 score on a scale
Standard Deviation 6.62
|
|
Anxiety as Assessed by the Parkinson Anxiety Scale (PAS) Score
Week 27
|
7.63 score on a scale
Standard Deviation 4.9
|
7.64 score on a scale
Standard Deviation 5.33
|
7.93 score on a scale
Standard Deviation 7.55
|
|
Anxiety as Assessed by the Parkinson Anxiety Scale (PAS) Score
Week 40
|
7.38 score on a scale
Standard Deviation 5.66
|
8.46 score on a scale
Standard Deviation 5.61
|
7.43 score on a scale
Standard Deviation 6.60
|
|
Anxiety as Assessed by the Parkinson Anxiety Scale (PAS) Score
Week 62
|
7.75 score on a scale
Standard Deviation 6.07
|
9.15 score on a scale
Standard Deviation 5.91
|
9.38 score on a scale
Standard Deviation 7.67
|
|
Anxiety as Assessed by the Parkinson Anxiety Scale (PAS) Score
Week 88
|
8.79 score on a scale
Standard Deviation 7.76
|
8 score on a scale
Standard Deviation 6.16
|
7.18 score on a scale
Standard Deviation 6.59
|
SECONDARY outcome
Timeframe: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88Population: Data was collected from participants who attended the visit and completed the assessment at each time point.
The Geriatric Depression Scale-Short Form (GDS-SF) assesses depressive symptoms. The total score ranges from 0 to 15, with higher scores indicating greater depressive symptom severity.
Outcome measures
| Measure |
Mesenchymal Stem Cells
n=16 Participants
3 infusions of 10 X 10\^6 MSC/kg administered every 4 months.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
|
Mesenchymal Stem Cells and Placebo
n=14 Participants
2 infusions of 10 X 10\^6 MSC/kg and 1 placebo infusion, all doses administered 4 months apart.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
Placebo
n=15 Participants
3 placebo doses administered every 4 months.
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
|---|---|---|---|
|
Depressive Symptoms as Assessed by the Geriatric Depression Scale-Short Form (GDS-SF) Score
Baseline
|
3.06 score on a scale
Standard Deviation 2.93
|
1.43 score on a scale
Standard Deviation 1.16
|
1.47 score on a scale
Standard Deviation 1.77
|
|
Depressive Symptoms as Assessed by the Geriatric Depression Scale-Short Form (GDS-SF) Score
Week 9
|
2.44 score on a scale
Standard Deviation 3.08
|
1.07 score on a scale
Standard Deviation 0.92
|
1.50 score on a scale
Standard Deviation 1.91
|
|
Depressive Symptoms as Assessed by the Geriatric Depression Scale-Short Form (GDS-SF) Score
Week 27
|
2.69 score on a scale
Standard Deviation 1.96
|
1.14 score on a scale
Standard Deviation 1.03
|
1.43 score on a scale
Standard Deviation 1.45
|
|
Depressive Symptoms as Assessed by the Geriatric Depression Scale-Short Form (GDS-SF) Score
Week 40
|
2.25 score on a scale
Standard Deviation 2.89
|
1.62 score on a scale
Standard Deviation 2.18
|
1.64 score on a scale
Standard Deviation 1.78
|
|
Depressive Symptoms as Assessed by the Geriatric Depression Scale-Short Form (GDS-SF) Score
Week 62
|
3.44 score on a scale
Standard Deviation 3.24
|
1.69 score on a scale
Standard Deviation 1.6
|
1.85 score on a scale
Standard Deviation 1.91
|
|
Depressive Symptoms as Assessed by the Geriatric Depression Scale-Short Form (GDS-SF) Score
Week 88
|
2.64 score on a scale
Standard Deviation 3.69
|
1.77 score on a scale
Standard Deviation 1.42
|
2.00 score on a scale
Standard Deviation 1.79
|
SECONDARY outcome
Timeframe: Week 9, Week 27, Week 49, Week 62, Week 88Population: Data was collected from participants who attended the visit and completed the assessment at each time point.
The Columbia-Suicide Severity Rating Scale (C-SSRS) assesses suicidal ideation and behavior. Reported is the number of participants with a positive response to the suicidal ideation question, "Have you actually had any thoughts of killing yourself?" since the previous study visit.
Outcome measures
| Measure |
Mesenchymal Stem Cells
n=16 Participants
3 infusions of 10 X 10\^6 MSC/kg administered every 4 months.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
|
Mesenchymal Stem Cells and Placebo
n=14 Participants
2 infusions of 10 X 10\^6 MSC/kg and 1 placebo infusion, all doses administered 4 months apart.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
Placebo
n=15 Participants
3 placebo doses administered every 4 months.
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
|---|---|---|---|
|
Number of Participants Reporting Suicidal Ideation Since Last Visit
Week 9
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Suicidal Ideation Since Last Visit
Week 27
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Suicidal Ideation Since Last Visit
Week 49
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Suicidal Ideation Since Last Visit
Week 62
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Suicidal Ideation Since Last Visit
Week 88
|
1 Participants
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88Examples of these are Glial Derived Neurotrophic Factor, Brain Derived Neurotrophic Factor and Vascular Epidermal Growth Factor . These will be measured by ELISA specific to blood and CSF.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88Examples of these are CCL2 (MCP-1), CCL7 (MCP-3), CCL11 (Eotaxin) CCL2 (MDC), CXCL10 (IP-10), CX3CL1 (Fractalkine). These will be measured by Magnetic Bead Panel - Multiplex Assay or ELISA, allowing for specificity in the blood.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88Examples of these are homovanillic acid and 5-hydroxytryptamine. These will be measured in CSF and blood by ELISA.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 40, Week 49Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline,week 49Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 9, Week 27, Week 40, Week 62, Week 88Examples of these are IL-1beta, IL-6, TNF-alpha, COX-2 and PGE-2. These are measured by Magnetic Bead Panel - Multiplex Assay or ELISA, allowing for specificity in the blood.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, week 40,week 88Outcome measures
Outcome data not reported
Adverse Events
Mesenchymal Stem Cells
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Mesenchymal Stem Cells and Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo
Serious events: 4 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mesenchymal Stem Cells
n=16 participants at risk
3 infusions of 10 X 10\^6 MSC/kg administered every 4 months.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
|
Mesenchymal Stem Cells and Placebo
n=14 participants at risk
2 infusions of 10 X 10\^6 MSC/kg and 1 placebo infusion, all doses administered 4 months apart.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
Placebo
n=15 participants at risk
3 placebo doses administered every 4 months.
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
|---|---|---|---|
|
Cardiac disorders
Acute decompensated heart failure with progressive dyspnea, orthopnea (hospitalized)
|
0.00%
0/16 • up to 88 weeks
|
0.00%
0/14 • up to 88 weeks
|
6.7%
1/15 • up to 88 weeks
|
|
Cardiac disorders
Non-ST elevation myocardial infarction with percutaneous coronary intervention
|
0.00%
0/16 • up to 88 weeks
|
0.00%
0/14 • up to 88 weeks
|
6.7%
1/15 • up to 88 weeks
|
|
Psychiatric disorders
PD Psychosis with hospitalization (disorganized thought, hallucinations, delusions)
|
0.00%
0/16 • up to 88 weeks
|
0.00%
0/14 • up to 88 weeks
|
6.7%
1/15 • up to 88 weeks
|
|
Renal and urinary disorders
Obstructing ureteral calculus with hydronephrosis s/p extracorporeal shockwave lithotripsy
|
0.00%
0/16 • up to 88 weeks
|
0.00%
0/14 • up to 88 weeks
|
6.7%
1/15 • up to 88 weeks
|
|
Musculoskeletal and connective tissue disorders
Post-surgical complications (C6-C7 hardware removal, ACDF)
|
0.00%
0/16 • up to 88 weeks
|
0.00%
0/14 • up to 88 weeks
|
6.7%
1/15 • up to 88 weeks
|
Other adverse events
| Measure |
Mesenchymal Stem Cells
n=16 participants at risk
3 infusions of 10 X 10\^6 MSC/kg administered every 4 months.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
|
Mesenchymal Stem Cells and Placebo
n=14 participants at risk
2 infusions of 10 X 10\^6 MSC/kg and 1 placebo infusion, all doses administered 4 months apart.
Mesenchymal Stem Cells: 1 dose is 10 X 10\^6 MSC/kg
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
Placebo
n=15 participants at risk
3 placebo doses administered every 4 months.
Placebo: Placebo will be identical to the investigational product but will not contain mesenchymal stem cells (MSCs).
|
|---|---|---|---|
|
Immune system disorders
Development of donor-specific HLA Class II antibody (DQB1*06:04)
|
0.00%
0/16 • up to 88 weeks
|
0.00%
0/14 • up to 88 weeks
|
6.7%
1/15 • up to 88 weeks
|
|
General disorders
Fatigue
|
0.00%
0/16 • up to 88 weeks
|
0.00%
0/14 • up to 88 weeks
|
6.7%
1/15 • up to 88 weeks
|
|
General disorders
Flu-like symptoms (headache, chills, muscle aches) with cold sores
|
0.00%
0/16 • up to 88 weeks
|
7.1%
1/14 • up to 88 weeks
|
0.00%
0/15 • up to 88 weeks
|
|
General disorders
General malaise
|
6.2%
1/16 • up to 88 weeks
|
0.00%
0/14 • up to 88 weeks
|
0.00%
0/15 • up to 88 weeks
|
|
General disorders
Headache (mild, global, non-radiating)
|
0.00%
0/16 • up to 88 weeks
|
7.1%
1/14 • up to 88 weeks
|
0.00%
0/15 • up to 88 weeks
|
|
General disorders
Hot flashes (facial)
|
0.00%
0/16 • up to 88 weeks
|
0.00%
0/14 • up to 88 weeks
|
6.7%
1/15 • up to 88 weeks
|
|
General disorders
Nausea
|
0.00%
0/16 • up to 88 weeks
|
0.00%
0/14 • up to 88 weeks
|
6.7%
1/15 • up to 88 weeks
|
|
Vascular disorders
Transient hypertension with headache
|
6.2%
1/16 • up to 88 weeks
|
0.00%
0/14 • up to 88 weeks
|
0.00%
0/15 • up to 88 weeks
|
|
Gastrointestinal disorders
Vomiting with nausea/gagging
|
6.2%
1/16 • up to 88 weeks
|
0.00%
0/14 • up to 88 weeks
|
0.00%
0/15 • up to 88 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck/trapezius muscle pain (myalgia) with fatigue, post-infusion
|
0.00%
0/16 • up to 88 weeks
|
0.00%
0/14 • up to 88 weeks
|
6.7%
1/15 • up to 88 weeks
|
Additional Information
Mya Schiess, MD
The University of Texas Health Science Center at Houston
Phone: 713-500-7051
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place