Trial Outcomes & Findings for Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects With Symptomatic Ischemic Heart Disease. (ACESO-IHD) (NCT NCT04776239)
NCT ID: NCT04776239
Last Updated: 2026-06-16
Results Overview
Endothelial progenitor cells (EPC)-colony forming units (CFUs) will be assessed from blood samples. The unit of measure is the average number of colonies per well.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
26 participants
Primary outcome timeframe
Baseline, Week 2, Month 1, Month 3, and Month 6
Results posted on
2026-06-16
Participant Flow
Participant milestones
| Measure |
Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group
Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Group B: Placebo Group
Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.
Placebo: Placebo delivered via peripheral intravenous infusion
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group
Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Group B: Placebo Group
Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.
Placebo: Placebo delivered via peripheral intravenous infusion
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
Baseline Characteristics
Allogeneic Mesenchymal Human Stem Cell Infusion Therapy for Endothelial DySfunctiOn in Diabetic Subjects With Symptomatic Ischemic Heart Disease. (ACESO-IHD)
Baseline characteristics by cohort
| Measure |
Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group
n=13 Participants
Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Group B: Placebo Group
n=13 Participants
Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.
Placebo: Placebo delivered via peripheral intravenous infusion
|
Total
n=26 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.85 years
STANDARD_DEVIATION 6.47 • n=20 Participants
|
62.62 years
STANDARD_DEVIATION 10.99 • n=20 Participants
|
63.23 years
STANDARD_DEVIATION 8.95 • n=40 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
23 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
17 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=20 Participants
|
11 Participants
n=20 Participants
|
24 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Month 1, Month 3, and Month 6Population: Two subjects (1 in each group) were lost to follow up before completing the study.
FMD% is measured via brachial artery ultrasound. The unit of measure is percent.
Outcome measures
| Measure |
Group B: Placebo Group
n=13 Participants
Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.
Placebo: Placebo delivered via peripheral intravenous infusion
|
Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group
n=13 Participants
Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
|---|---|---|
|
Brachial Artery Flow Mediated Diameter Percentage (FMD%)
Baseline
|
4.28 percentage
Standard Deviation 2.10
|
5.80 percentage
Standard Deviation 3.46
|
|
Brachial Artery Flow Mediated Diameter Percentage (FMD%)
Week 2
|
5.93 percentage
Standard Deviation 3.13
|
6.98 percentage
Standard Deviation 3.39
|
|
Brachial Artery Flow Mediated Diameter Percentage (FMD%)
Month 1
|
5.64 percentage
Standard Deviation 2.65
|
7.19 percentage
Standard Deviation 2.84
|
|
Brachial Artery Flow Mediated Diameter Percentage (FMD%)
Month 3
|
6.20 percentage
Standard Deviation 2.94
|
7.48 percentage
Standard Deviation 3.59
|
|
Brachial Artery Flow Mediated Diameter Percentage (FMD%)
Month 6
|
5.62 percentage
Standard Deviation 1.79
|
7.2 percentage
Standard Deviation 2.93
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Month 1, Month 3, and Month 6Population: The number of subjects analyzed are less than the overall totals because the EPC-CFU assay protocol was altered midway through the trial; therefore, only a sub-set of subjects have complete data for this assay.
Endothelial progenitor cells (EPC)-colony forming units (CFUs) will be assessed from blood samples. The unit of measure is the average number of colonies per well.
Outcome measures
| Measure |
Group B: Placebo Group
n=6 Participants
Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.
Placebo: Placebo delivered via peripheral intravenous infusion
|
Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group
n=6 Participants
Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
|---|---|---|
|
EPC-CFU Counts
Month 6
|
20.83 CFUs per well
Interval 4.33 to 33.5
|
3.5 CFUs per well
Interval 0.33 to 12.7
|
|
EPC-CFU Counts
Baseline
|
8.67 CFUs per well
Interval 7.33 to 12.33
|
4.92 CFUs per well
Interval 1.42 to 7.38
|
|
EPC-CFU Counts
Week 2
|
11.67 CFUs per well
Interval 10.67 to 12.5
|
12.16 CFUs per well
Interval 4.46 to 17.7
|
|
EPC-CFU Counts
Month 1
|
10.75 CFUs per well
Interval 5.17 to 14.83
|
11.34 CFUs per well
Interval 4.59 to 15.75
|
|
EPC-CFU Counts
Month 3
|
28.5 CFUs per well
Interval 3.17 to 31.0
|
7.83 CFUs per well
Interval 7.0 to 9.16
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Few subjects from either group did not have cardiac catheterization at baseline, or were lost to follow up before the Month 6 catheterization.
Fractional Flow Reserve as assessed by during cardiac catheterization angiography. The values are presented as a ratio.
Outcome measures
| Measure |
Group B: Placebo Group
n=10 Participants
Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.
Placebo: Placebo delivered via peripheral intravenous infusion
|
Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group
n=11 Participants
Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
|---|---|---|
|
Fractional Flow Reserve (FFR)
Baseline
|
0.9 ratio
Standard Deviation 0.07
|
0.83 ratio
Standard Deviation 0.24
|
|
Fractional Flow Reserve (FFR)
Month 6
|
0.86 ratio
Standard Deviation 0.08
|
0.9 ratio
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: Baseline, Month 6Population: Few subjects from either group did not have cardiac catheterization at baseline, or were lost to follow up before the Month 6 catheterization.
Coronary Flow Reserve as assessed by during cardiac catheterization angiography. The values are presented as a ratio.
Outcome measures
| Measure |
Group B: Placebo Group
n=7 Participants
Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.
Placebo: Placebo delivered via peripheral intravenous infusion
|
Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group
n=9 Participants
Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
|---|---|---|
|
Coronary Flow Reserve (CFR)
Baseline
|
2.64 ratio
Standard Deviation 1.78
|
2.82 ratio
Standard Deviation 1.22
|
|
Coronary Flow Reserve (CFR)
Month 6
|
3.78 ratio
Standard Deviation 2.99
|
2.55 ratio
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Month 1, Month 3, and Month 6Population: Two subjects (1 in each group) were lost to follow up before completing the study.
SAQ is a 7 item questionnaire with a total score ranging from 0-100 with the higher scores indicating less physical limitations, less angina, symptom frequency and better quality of life. The unit of measure is score on a scale.
Outcome measures
| Measure |
Group B: Placebo Group
n=13 Participants
Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.
Placebo: Placebo delivered via peripheral intravenous infusion
|
Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group
n=13 Participants
Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
|---|---|---|
|
Seattle Angina Questionnaire (SAQ) Angina Frequency (AF)
Baseline
|
84.62 score on a scale
Standard Deviation 25.04
|
76.15 score on a scale
Standard Deviation 33.55
|
|
Seattle Angina Questionnaire (SAQ) Angina Frequency (AF)
Week 2
|
90.77 score on a scale
Standard Deviation 11.88
|
87.5 score on a scale
Standard Deviation 24.54
|
|
Seattle Angina Questionnaire (SAQ) Angina Frequency (AF)
Month 1
|
94.62 score on a scale
Standard Deviation 9.67
|
90 score on a scale
Standard Deviation 17.32
|
|
Seattle Angina Questionnaire (SAQ) Angina Frequency (AF)
Month 3
|
95.38 score on a scale
Standard Deviation 9.67
|
86.67 score on a scale
Standard Deviation 25.35
|
|
Seattle Angina Questionnaire (SAQ) Angina Frequency (AF)
Month 6
|
95.83 score on a scale
Standard Deviation 11.65
|
90 score on a scale
Standard Deviation 20
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Month 1, Month 3, and Month 6Population: Two subjects (1 in each group) were lost to follow up before completing the study.
SAQ is a 7 item questionnaire with a total score ranging from 0-100 with the higher scores indicating less physical limitations, less angina, symptom frequency and better quality of life. The unit of measure is score on a scale.
Outcome measures
| Measure |
Group B: Placebo Group
n=13 Participants
Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.
Placebo: Placebo delivered via peripheral intravenous infusion
|
Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group
n=13 Participants
Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
|---|---|---|
|
Seattle Angina Questionnaire (SAQ) Quality of Life (QL)
Baseline
|
54.81 score on a scale
Standard Deviation 24.76
|
53.85 score on a scale
Standard Deviation 35.5
|
|
Seattle Angina Questionnaire (SAQ) Quality of Life (QL)
Week 2
|
70.19 score on a scale
Standard Deviation 29.11
|
69.79 score on a scale
Standard Deviation 23.51
|
|
Seattle Angina Questionnaire (SAQ) Quality of Life (QL)
Month 3
|
82.69 score on a scale
Standard Deviation 26.29
|
71.88 score on a scale
Standard Deviation 27.76
|
|
Seattle Angina Questionnaire (SAQ) Quality of Life (QL)
Month 1
|
63.46 score on a scale
Standard Deviation 25.24
|
73.08 score on a scale
Standard Deviation 22.73
|
|
Seattle Angina Questionnaire (SAQ) Quality of Life (QL)
Month 6
|
65.63 score on a scale
Standard Deviation 32.48
|
72.92 score on a scale
Standard Deviation 27.61
|
SECONDARY outcome
Timeframe: 1 month post infusionTE-SAEs will be defined as the composite of: death, non-fatal myocardial infarction (MI), stroke, hospitalization for heart failure, sustained ventricular arrhythmias (characterized by ventricular arrhythmias lasting longer than 30 sec or with hemodynamic compromise) or atrial fibrillation at 1 month post-infusion. TE-SAEs will be assessed by treating physician. The unit of measurement is the number of participants who experienced an event.
Outcome measures
| Measure |
Group B: Placebo Group
n=13 Participants
Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.
Placebo: Placebo delivered via peripheral intravenous infusion
|
Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group
n=13 Participants
Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
|---|---|---|
|
Number of Participants With Treatment-Emergent Serious Adverse Events (TE-SAE)
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 monthsDefined as the composite incidence of (1) death, (2) hospitalization for cardiovascular events or (3) non-fatal myocardial infarction MI at 1 year. MACE will be assessed by treating physician. The unit of measurement is the number of participants who experienced an event.
Outcome measures
| Measure |
Group B: Placebo Group
n=13 Participants
Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.
Placebo: Placebo delivered via peripheral intravenous infusion
|
Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group
n=13 Participants
Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
|---|---|---|
|
Number of Participants With Major Adverse Cardiac Events (MACE)
|
3 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: This analysis only includes participants with obstructive CAD (coronary artery disease) at baseline who required stent placement.
Number of participants with target vessel failure will be reported. Target vessel failure is defined as any participant that encounters revascularization, death, or MI attributed to the target vessel post-PCI (percutaneous coronary intervention). The unit of measure is number of participants.
Outcome measures
| Measure |
Group B: Placebo Group
n=9 Participants
Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.
Placebo: Placebo delivered via peripheral intravenous infusion
|
Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group
n=11 Participants
Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
|---|---|---|
|
Number of Participants With Target Vessel Failure
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsThe number of participants who experienced a Treatment Emergent Adverse Event (AE), as assessed by study physician, will be reported. The unit of measurement is the number of participants who experienced an event.
Outcome measures
| Measure |
Group B: Placebo Group
n=13 Participants
Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.
Placebo: Placebo delivered via peripheral intravenous infusion
|
Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group
n=13 Participants
Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 monthsNumber of participants with clinically significant abnormal serum hematology and clinical chemistry values will be reported. Clinical significance will be assessed by treating physician. The unit of measure is number of participants.
Outcome measures
| Measure |
Group B: Placebo Group
n=13 Participants
Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.
Placebo: Placebo delivered via peripheral intravenous infusion
|
Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group
n=13 Participants
Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
|---|---|---|
|
Number of Participants With Abnormal Lab Values
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 3, Month 6Population: Two subjects (1 in each group) were lost to follow up before completing the study.
Vascular Endothelial Growth Factor (VEGF) levels from serum samples. Results are provided in units of pg/mL. Higher levels of VEGF are associated with better cardiovascular health.
Outcome measures
| Measure |
Group B: Placebo Group
n=13 Participants
Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.
Placebo: Placebo delivered via peripheral intravenous infusion
|
Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group
n=13 Participants
Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
|---|---|---|
|
Circulating Angiogenic Marker - VEGF
VEGF Month 6
|
1234.75 pg/mL
Standard Deviation 566.07
|
1057.23 pg/mL
Standard Deviation 425.58
|
|
Circulating Angiogenic Marker - VEGF
VEGF Month 3
|
1173.4 pg/mL
Standard Deviation 469.88
|
1243.28 pg/mL
Standard Deviation 432.1
|
|
Circulating Angiogenic Marker - VEGF
VEGF Baseline
|
1,303.36 pg/mL
Standard Deviation 604.34
|
1,169.62 pg/mL
Standard Deviation 379.73
|
|
Circulating Angiogenic Marker - VEGF
VEGF Month 1
|
1251.62 pg/mL
Standard Deviation 588.55
|
1,220.7 pg/mL
Standard Deviation 380.24
|
SECONDARY outcome
Timeframe: Baseline, Month 1, Month 3, Month 6Population: Two subjects (1 in each group) were lost to follow up before completing the study.
Circulating Tumor necrosis factor alpha (TNFα) levels from serum samples. Results are provided in units of pg/mL. Lower values are associated with reduced inflammation.
Outcome measures
| Measure |
Group B: Placebo Group
n=13 Participants
Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.
Placebo: Placebo delivered via peripheral intravenous infusion
|
Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group
n=13 Participants
Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
|---|---|---|
|
Circulating Cytokine Biomarker - TNFα
TNFα - Baseline
|
13.02 pg/mL
Standard Deviation 2.96
|
14.70 pg/mL
Standard Deviation 4.49
|
|
Circulating Cytokine Biomarker - TNFα
TNFα - Month 1
|
12.90 pg/mL
Standard Deviation 2.99
|
14.50 pg/mL
Standard Deviation 5.51
|
|
Circulating Cytokine Biomarker - TNFα
TNFα - Month 3
|
14.09 pg/mL
Standard Deviation 5.08
|
12.54 pg/mL
Standard Deviation 2.23
|
|
Circulating Cytokine Biomarker - TNFα
TNFα - Month 6
|
18.36 pg/mL
Standard Deviation 14.68
|
15.53 pg/mL
Standard Deviation 7.90
|
Adverse Events
Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Group B: Placebo Group
Serious events: 4 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group
n=13 participants at risk
Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Group B: Placebo Group
n=13 participants at risk
Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.
Placebo: Placebo delivered via peripheral intravenous infusion
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Cardiac disorders
Acute Coronary Syndrome
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
|
Cardiac disorders
Cardiac Chest Pain
|
7.7%
1/13 • Number of events 1 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Cardiac disorders
Heart Failure Exacerbation
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
|
General disorders
Non-Cardiac Chest Pain
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
|
Infections and infestations
Lung Infection
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
|
Injury, poisoning and procedural complications
Carotid Artery Injury
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
|
Investigations
Increased Creatinine
|
0.00%
0/13 • 1 year
|
15.4%
2/13 • Number of events 2 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Nervous system disorders
Syncope
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
|
Vascular disorders
Peripheral Ischemia
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Vascular disorders
Thromboembolism
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
Other adverse events
| Measure |
Group A: Allogeneic Mesenchymal Stem Cells (MSCs) Group
n=13 participants at risk
Participants in this group will be receive a single administration of intravenous allogeneic human Mesenchymal Stem Cells (hMSCs) (100 million).
100 million Allogeneic Mesenchymal Human Stem Cells: 1 single intravenous infusion
|
Group B: Placebo Group
n=13 participants at risk
Participants in this group will receive a single dose of placebo (Cell-free PlasmaLyte-A medium supplemented with 1% HSA) infusion.
Placebo: Placebo delivered via peripheral intravenous infusion
|
|---|---|---|
|
General disorders
Vaccination Site Lymphadenopathy
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
7.7%
1/13 • Number of events 1 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Infections and infestations
Lung Infection
|
0.00%
0/13 • 1 year
|
15.4%
2/13 • Number of events 2 • 1 year
|
|
Infections and infestations
Nail Infection
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Infections and infestations
Upper respiratory infection
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Investigations
Prolonged APTT
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
|
Investigations
AST increased
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Investigations
Creatinine increased
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate carcinoma
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Nervous system disorders
Concentration impairment
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
|
Nervous system disorders
Dizziness
|
0.00%
0/13 • 1 year
|
15.4%
2/13 • Number of events 2 • 1 year
|
|
Nervous system disorders
Headache
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Nervous system disorders
Myasthenia gravis
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Nervous system disorders
Paresthesia
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
|
Nervous system disorders
Somnolence
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
|
Psychiatric disorders
Anxiety
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
|
Renal and urinary disorders
Renal calculi
|
7.7%
1/13 • Number of events 1 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.4%
2/13 • Number of events 2 • 1 year
|
0.00%
0/13 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
|
Skin and subcutaneous tissue disorders
Skin Burn
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
|
Vascular disorders
Arterial thromboembolism
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Vascular disorders
Peripheral ischemia
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Vascular disorders
Worsening Peripheral Disease
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Cardiac disorders
Palpitations
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Eye disorders
Left Eye Diplopia
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
|
Gastrointestinal disorders
Abdominal Pain
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
|
General disorders
Edema Limbs
|
0.00%
0/13 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
General disorders
Fatigue
|
7.7%
1/13 • Number of events 1 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
General disorders
Non-Cardiac Chest Pain
|
7.7%
1/13 • Number of events 1 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
15.4%
2/13 • Number of events 2 • 1 year
|
0.00%
0/13 • 1 year
|
|
Blood and lymphatic system disorders
Bilateral Axillary Adenopathy
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
|
Cardiac disorders
Atrial Flutter
|
7.7%
1/13 • Number of events 1 • 1 year
|
0.00%
0/13 • 1 year
|
|
Cardiac disorders
Cardiac Chest Pain
|
23.1%
3/13 • Number of events 3 • 1 year
|
7.7%
1/13 • Number of events 1 • 1 year
|
|
Cardiac disorders
Heart Failiure Exacerbation
|
0.00%
0/13 • 1 year
|
15.4%
2/13 • Number of events 2 • 1 year
|
|
Cardiac disorders
In stent re-stenosis
|
0.00%
0/13 • 1 year
|
15.4%
2/13 • Number of events 2 • 1 year
|
Additional Information
Joshua M. Hare, MD
University of Miami, Miller School of Medicine - Interdisciplinary Stem Cell Institute (ISCI)
Phone: 305-243-5579
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place