Trial Outcomes & Findings for Infusion of Umbilical Cord Versus Bone Marrow Derived Mesenchymal Stem Cells to Evaluate Cytokine Suppression. (NCT NCT03059355)
NCT ID: NCT03059355
Last Updated: 2022-11-08
Results Overview
Number of treatment-emergent serious adverse events (SAE) (at one-month post infusion), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities, determined per the Investigator's judgment.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
14 participants
Primary outcome timeframe
one month post infusion
Results posted on
2022-11-08
Participant Flow
No subjects had been randomized to Group A or C at the time of trial termination.
Participant milestones
| Measure |
Pilot Phase: Group 1 (UCMSCs - 20 Million)
Three (3) subjects will be treated with a single administration of 2 x 10\^7 (20 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived Mesenchymal Stem Cells (MSC).
|
Pilot Phase: Group 2 (BMMSCs - 20 Million)
Three (3) subjects will be treated with a single IV administration of 2 x 10\^7 (20 million) BMMSCs delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Pilot Phase: Group 3 (UCMSCs - 100 Million)
Three (3) subjects will be treated with a single IV administration of 1 x 10\^8 (100 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
|
Pilot Phase: Group 4 (BMMSCs -100 Million)
Three (3) subjects will be treated with a single IV administration of 1 x 10\^8 (100 million) BMMSCs delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Group A (UCMSCs - 100 Million)
Participants randomized to receive a single administration of 1 x 10\^8 (100 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
|
Group B (BMMSCs - 100 Million)
Participants randomized to receive a single administration of 1 x 10\^8 (100 million) BMMSC delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Group C (Placebo)
Participants randomized to receive a single administration of placebo via peripheral intravenous infusion.
Placebo: a single administration of placebo delivered via peripheral intravenous infusion.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
3
|
0
|
2
|
0
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
3
|
0
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Infusion of Umbilical Cord Versus Bone Marrow Derived Mesenchymal Stem Cells to Evaluate Cytokine Suppression.
Baseline characteristics by cohort
| Measure |
Pilot Phase: Group 1 (UCMSCs - 20 Million)
n=3 Participants
Three (3) subjects will be treated with a single administration of 2 x 10\^7 (20 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
|
Pilot Phase: Group 2 (BMMSCs - 20 Million)
n=3 Participants
Three (3) subjects will be treated with a single IV administration of 2 x 10\^7 (20 million) BMMSCs delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Pilot Phase: Group 3 (UCMSCs - 100 Million)
n=3 Participants
Three (3) subjects will be treated with a single IV administration of 1 x 10\^8 (100 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
|
Pilot Phase: Group 4 (BMMSCs -100 Million)
n=3 Participants
Three (3) subjects will be treated with a single IV administration of 1 x 10\^8 (100 million) BMMSCs delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Group A (UCMSCs - 100 Million)
Participants randomized to receive a single administration of 1 x 10\^8 (100 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
|
Group B (BMMSCs - 100 Million)
n=2 Participants
Participants randomized to receive a single administration of 1 x 10\^8 (100 million) BMMSC delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Group C (Placebo)
Participants randomized to receive a single administration of placebo via peripheral intravenous infusion.
Placebo: a single administration of placebo delivered via peripheral intravenous infusion.
|
Total
n=14 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
85.67 years
STANDARD_DEVIATION 5.13 • n=5 Participants
|
62.00 years
STANDARD_DEVIATION 8.72 • n=7 Participants
|
61.67 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
60.67 years
STANDARD_DEVIATION 12.42 • n=4 Participants
|
—
|
52 years
STANDARD_DEVIATION 12.73 • n=8 Participants
|
—
|
65.17 years
STANDARD_DEVIATION 13.29 • n=24 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
9 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
11 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: one month post infusionPopulation: No subjects had been randomized to Group A or C at the time of trial termination.
Number of treatment-emergent serious adverse events (SAE) (at one-month post infusion), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities, determined per the Investigator's judgment.
Outcome measures
| Measure |
Pilot Phase: Group 4 (BMMSCs -100 Million)
n=3 Participants
Three (3) subjects will be treated with a single IV administration of 1 x 10\^8 (100 million) BMMSCs delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Group A (UCMSCs - 100 Million)
Participants randomized to receive a single administration of 1 x 10\^8 (100 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
|
Group B (BMMSCs - 100 Million)
n=2 Participants
Participants randomized to receive a single administration of 1 x 10\^8 (100 million) BMMSC delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Group C (Placebo)
Participants randomized to receive a single administration of placebo via peripheral intravenous infusion.
Placebo: a single administration of placebo delivered via peripheral intravenous infusion.
|
Pilot Phase: Group 1 (UCMSCs - 20 Million)
n=3 Participants
Three (3) subjects will be treated with a single administration of 2 x 10\^7 (20 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
|
Pilot Phase: Group 2 (BMMSCs - 20 Million)
n=3 Participants
Three (3) subjects will be treated with a single IV administration of 2 x 10\^7 (20 million) BMMSCs delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Pilot Phase: Group 3 (UCMSCs - 100 Million)
n=3 Participants
Three (3) subjects will be treated with a single IV administration of 1 x 10\^8 (100 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
|
|---|---|---|---|---|---|---|---|
|
Number of Treatment-Emergent Serious Adverse Events (TE-SAEs)
|
0 Events
|
—
|
0 Events
|
—
|
0 Events
|
0 Events
|
0 Events
|
SECONDARY outcome
Timeframe: at Baseline, at Week 2, at Month 1, at Month 3, and at Month 6Population: Some participants did not complete all of the study visits per protocol due to COVID-19 pandemic restrictions. Therefore not all data is available for all time-points for all participants. Blood samples were collected for IL-1 and SDF-1a analysis, however due to cost and logistical reasons the samples were not analyzed. VEGF were to be analyzed internally using frozen plasma aliquots. No plasma samples were retained for internal testing at week 2, month 1, and month 6 in all participants.
Cytokine levels including the following panel of inflammatory and angiogenic markers: Interleukin-1 (IL-1), Interleukin-6 (IL-6), Tumor Necrosis Factor alpha (TNFα), and Vascular Endothelial Growth Factor (VEGF), \& Stromal Cell Derived Factor (SDF-1a) levels from serum/plasma samples all measured in pg/mL.
Outcome measures
| Measure |
Pilot Phase: Group 4 (BMMSCs -100 Million)
n=3 Participants
Three (3) subjects will be treated with a single IV administration of 1 x 10\^8 (100 million) BMMSCs delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Group A (UCMSCs - 100 Million)
Participants randomized to receive a single administration of 1 x 10\^8 (100 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
|
Group B (BMMSCs - 100 Million)
n=2 Participants
Participants randomized to receive a single administration of 1 x 10\^8 (100 million) BMMSC delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Group C (Placebo)
Participants randomized to receive a single administration of placebo via peripheral intravenous infusion.
Placebo: a single administration of placebo delivered via peripheral intravenous infusion.
|
Pilot Phase: Group 1 (UCMSCs - 20 Million)
n=3 Participants
Three (3) subjects will be treated with a single administration of 2 x 10\^7 (20 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
|
Pilot Phase: Group 2 (BMMSCs - 20 Million)
n=3 Participants
Three (3) subjects will be treated with a single IV administration of 2 x 10\^7 (20 million) BMMSCs delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Pilot Phase: Group 3 (UCMSCs - 100 Million)
n=3 Participants
Three (3) subjects will be treated with a single IV administration of 1 x 10\^8 (100 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
|
|---|---|---|---|---|---|---|---|
|
Cytokine Levels
IL-6 Baseline
|
2.9 pg/mL
Standard Deviation 1.9
|
—
|
1.2 pg/mL
Standard Deviation 0.6
|
—
|
5.7 pg/mL
Standard Deviation 4.8
|
2.7 pg/mL
Standard Deviation 1.8
|
3.2 pg/mL
Standard Deviation 2.5
|
|
Cytokine Levels
IL-6 Week 2
|
3.7 pg/mL
Standard Deviation 2.3
|
—
|
1.4 pg/mL
Standard Deviation 0.4
|
—
|
5.8 pg/mL
Standard Deviation 5.2
|
3.4 pg/mL
Standard Deviation 1.0
|
5.4 pg/mL
Standard Deviation 6.7
|
|
Cytokine Levels
IL-6 Month 1
|
2.1 pg/mL
Standard Deviation 0.9
|
—
|
1.3 pg/mL
|
—
|
5.4 pg/mL
Standard Deviation 3.9
|
2.8 pg/mL
Standard Deviation 1.0
|
2.5 pg/mL
Standard Deviation 1.0
|
|
Cytokine Levels
IL-6 Month 3
|
2.3 pg/mL
Standard Deviation 1.0
|
—
|
—
|
—
|
8.4 pg/mL
Standard Deviation 4.5
|
2.5 pg/mL
Standard Deviation 1.2
|
1.9 pg/mL
Standard Deviation 0.6
|
|
Cytokine Levels
IL-6 Month 6
|
2.2 pg/mL
Standard Deviation 0.4
|
—
|
—
|
—
|
2.9 pg/mL
Standard Deviation 2.2
|
3.2 pg/mL
Standard Deviation 1.3
|
3.8 pg/mL
Standard Deviation 3.0
|
|
Cytokine Levels
TNFa Baseline
|
2.1 pg/mL
Standard Deviation 0.5
|
—
|
1.1 pg/mL
Standard Deviation 0.2
|
—
|
1.7 pg/mL
Standard Deviation 0.4
|
1.6 pg/mL
Standard Deviation 0.4
|
1.6 pg/mL
Standard Deviation 0.8
|
|
Cytokine Levels
TNFa Week 2
|
2.1 pg/mL
Standard Deviation 0.7
|
—
|
0.9 pg/mL
Standard Deviation 0.3
|
—
|
1.9 pg/mL
Standard Deviation 0.8
|
1.5 pg/mL
Standard Deviation 0.6
|
1.5 pg/mL
Standard Deviation 0.6
|
|
Cytokine Levels
TNFa Month 1
|
2.2 pg/mL
Standard Deviation 0.8
|
—
|
0.7 pg/mL
|
—
|
1.7 pg/mL
Standard Deviation 1.1
|
1.5 pg/mL
Standard Deviation 0.3
|
2.0 pg/mL
Standard Deviation 0.9
|
|
Cytokine Levels
TNFa Month 6
|
1.0 pg/mL
Standard Deviation 0.5
|
—
|
0.5 pg/mL
|
—
|
1.5 pg/mL
Standard Deviation 0.6
|
1.4 pg/mL
Standard Deviation 0.3
|
1.4 pg/mL
Standard Deviation 0.3
|
|
Cytokine Levels
VEGF Baseline
|
13.5 pg/mL
Standard Deviation 1.7
|
—
|
—
|
—
|
13.5 pg/mL
Standard Deviation 4.8
|
19.2 pg/mL
Standard Deviation 9
|
25.1 pg/mL
Standard Deviation 14
|
|
Cytokine Levels
VEGF Month 3
|
9.5 pg/mL
Standard Deviation 1.8
|
—
|
—
|
—
|
15.3 pg/mL
Standard Deviation 3
|
16.5 pg/mL
Standard Deviation 12.4
|
15.5 pg/mL
Standard Deviation 6.4
|
|
Cytokine Levels
TNFa Month 3
|
1.8 pg/mL
Standard Deviation 0.5
|
—
|
0.7 pg/mL
|
—
|
2.2 pg/mL
Standard Deviation 1.7
|
1.2 pg/mL
Standard Deviation 0.5
|
1.8 pg/mL
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: at Baseline, at Week 2, at Month 1, at Month 3, and at Month 6Population: No subjects had been randomized to Group A or C at the time of trial termination. Some participants did not complete all of the study visits per protocol.
values at baseline and follow up for the following inflammatory marker: Serum High sensitivity C-Reactive Protein (hsCRP) in mg/L.
Outcome measures
| Measure |
Pilot Phase: Group 4 (BMMSCs -100 Million)
n=3 Participants
Three (3) subjects will be treated with a single IV administration of 1 x 10\^8 (100 million) BMMSCs delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Group A (UCMSCs - 100 Million)
Participants randomized to receive a single administration of 1 x 10\^8 (100 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
|
Group B (BMMSCs - 100 Million)
n=2 Participants
Participants randomized to receive a single administration of 1 x 10\^8 (100 million) BMMSC delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Group C (Placebo)
Participants randomized to receive a single administration of placebo via peripheral intravenous infusion.
Placebo: a single administration of placebo delivered via peripheral intravenous infusion.
|
Pilot Phase: Group 1 (UCMSCs - 20 Million)
n=3 Participants
Three (3) subjects will be treated with a single administration of 2 x 10\^7 (20 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
|
Pilot Phase: Group 2 (BMMSCs - 20 Million)
n=3 Participants
Three (3) subjects will be treated with a single IV administration of 2 x 10\^7 (20 million) BMMSCs delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Pilot Phase: Group 3 (UCMSCs - 100 Million)
n=3 Participants
Three (3) subjects will be treated with a single IV administration of 1 x 10\^8 (100 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
|
|---|---|---|---|---|---|---|---|
|
hsCRP Levels
Baseline
|
3.2 mg/L
Standard Deviation 1.9
|
—
|
0.5 mg/L
Standard Deviation 0.3
|
—
|
2.0 mg/L
Standard Deviation 1.6
|
13.0 mg/L
Standard Deviation 19.2
|
1.4 mg/L
Standard Deviation 0.4
|
|
hsCRP Levels
Week 2
|
4.3 mg/L
Standard Deviation 3.3
|
—
|
0.6 mg/L
Standard Deviation 0.3
|
—
|
9.2 mg/L
Standard Deviation 14.4
|
5.7 mg/L
Standard Deviation 6.0
|
1.7 mg/L
Standard Deviation 1.4
|
|
hsCRP Levels
Month 1
|
2.9 mg/L
Standard Deviation 1.2
|
—
|
0.6 mg/L
|
—
|
10.7 mg/L
Standard Deviation 16.0
|
4.6 mg/L
Standard Deviation 4.0
|
2.1 mg/L
Standard Deviation 1.4
|
|
hsCRP Levels
Month 3
|
3.4 mg/L
Standard Deviation 1.3
|
—
|
0.9 mg/L
|
—
|
5.0 mg/L
Standard Deviation 3.4
|
4.7 mg/L
Standard Deviation 5.1
|
2.7 mg/L
Standard Deviation 2.9
|
|
hsCRP Levels
Month 6
|
2.1 mg/L
|
—
|
0.6 mg/L
|
—
|
1.6 mg/L
Standard Deviation 1.1
|
5.4 mg/L
Standard Deviation 7.0
|
2.6 mg/L
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: at Baseline, at Week 2, at Month 1, at Month 3, and at Month 6Population: Blood samples were collected for SCF analysis, however due to cost and logistical reasons the samples were not analyzed and hence no data were generated.
SCF levels from serum/plasma samples measured in units of mg/mL
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: at Baseline, and at 3 monthsPopulation: No subjects had been randomized to Group A or C at the time of trial termination. Some participants did not complete all of the study visits per protocol.
Endothelial function will be reported as the change in Endothelial Progenitor Cell Colony Forming Unit (EPC-CFU) assessed via blood sample assay
Outcome measures
| Measure |
Pilot Phase: Group 4 (BMMSCs -100 Million)
n=3 Participants
Three (3) subjects will be treated with a single IV administration of 1 x 10\^8 (100 million) BMMSCs delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Group A (UCMSCs - 100 Million)
Participants randomized to receive a single administration of 1 x 10\^8 (100 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
|
Group B (BMMSCs - 100 Million)
n=2 Participants
Participants randomized to receive a single administration of 1 x 10\^8 (100 million) BMMSC delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Group C (Placebo)
Participants randomized to receive a single administration of placebo via peripheral intravenous infusion.
Placebo: a single administration of placebo delivered via peripheral intravenous infusion.
|
Pilot Phase: Group 1 (UCMSCs - 20 Million)
n=3 Participants
Three (3) subjects will be treated with a single administration of 2 x 10\^7 (20 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
|
Pilot Phase: Group 2 (BMMSCs - 20 Million)
n=3 Participants
Three (3) subjects will be treated with a single IV administration of 2 x 10\^7 (20 million) BMMSCs delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Pilot Phase: Group 3 (UCMSCs - 100 Million)
n=3 Participants
Three (3) subjects will be treated with a single IV administration of 1 x 10\^8 (100 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
|
|---|---|---|---|---|---|---|---|
|
Endothelial Progenitor Cell-Colony Forming Units (EPC-CFUs)
Baseline
|
4.8 Colony Forming Units per Well
Standard Deviation 6.6
|
—
|
0.6 Colony Forming Units per Well
Standard Deviation 0.6
|
—
|
15.0 Colony Forming Units per Well
Standard Deviation 14.5
|
0.8 Colony Forming Units per Well
Standard Deviation 0.9
|
2.3 Colony Forming Units per Well
Standard Deviation 3.1
|
|
Endothelial Progenitor Cell-Colony Forming Units (EPC-CFUs)
Month 3
|
1.9 Colony Forming Units per Well
Standard Deviation 2.0
|
—
|
—
|
—
|
20.4 Colony Forming Units per Well
Standard Deviation 20.8
|
1.3 Colony Forming Units per Well
Standard Deviation 1.1
|
13.2 Colony Forming Units per Well
Standard Deviation 13.6
|
SECONDARY outcome
Timeframe: at Baseline and at Month 3Population: No subjects had been randomized to Group A or C at the time of trial termination. Some participants did not complete all of the study visits per protocol.
FMD% will be assessed using brachial artery ultrasound
Outcome measures
| Measure |
Pilot Phase: Group 4 (BMMSCs -100 Million)
n=3 Participants
Three (3) subjects will be treated with a single IV administration of 1 x 10\^8 (100 million) BMMSCs delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Group A (UCMSCs - 100 Million)
Participants randomized to receive a single administration of 1 x 10\^8 (100 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
|
Group B (BMMSCs - 100 Million)
n=2 Participants
Participants randomized to receive a single administration of 1 x 10\^8 (100 million) BMMSC delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Group C (Placebo)
Participants randomized to receive a single administration of placebo via peripheral intravenous infusion.
Placebo: a single administration of placebo delivered via peripheral intravenous infusion.
|
Pilot Phase: Group 1 (UCMSCs - 20 Million)
n=3 Participants
Three (3) subjects will be treated with a single administration of 2 x 10\^7 (20 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
|
Pilot Phase: Group 2 (BMMSCs - 20 Million)
n=3 Participants
Three (3) subjects will be treated with a single IV administration of 2 x 10\^7 (20 million) BMMSCs delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Pilot Phase: Group 3 (UCMSCs - 100 Million)
n=3 Participants
Three (3) subjects will be treated with a single IV administration of 1 x 10\^8 (100 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
|
|---|---|---|---|---|---|---|---|
|
Flow Mediated Diameter Percentage (FMD%)
Baseline
|
3.1 percentage of change in brachial artery
Standard Deviation 1.4
|
—
|
5.0 percentage of change in brachial artery
Standard Deviation 0.8
|
—
|
3.6 percentage of change in brachial artery
Standard Deviation 2.0
|
4.1 percentage of change in brachial artery
Standard Deviation 1.1
|
3.6 percentage of change in brachial artery
Standard Deviation 0.8
|
|
Flow Mediated Diameter Percentage (FMD%)
Month 3
|
4.0 percentage of change in brachial artery
Standard Deviation 0.8
|
—
|
—
|
—
|
3.5 percentage of change in brachial artery
Standard Deviation 1.9
|
5.4 percentage of change in brachial artery
Standard Deviation 3.7
|
5.4 percentage of change in brachial artery
Standard Deviation 0.5
|
Adverse Events
Pilot Phase: Group 1 (UCMSCs - 20 Million)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Pilot Phase: Group 2 (BMMSCs - 20 Million)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Pilot Phase: Group 3 (UCMSCs - 100 Million)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Pilot Phase: Group 4 (BMMSCs -100 Million)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group A (UCMSCs - 100 Million)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group B (BMMSCs - 100 Million)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group C (Placebo)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pilot Phase: Group 1 (UCMSCs - 20 Million)
n=3 participants at risk
Three (3) subjects will be treated with a single administration of 2 x 10\^7 (20 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
|
Pilot Phase: Group 2 (BMMSCs - 20 Million)
n=3 participants at risk
Three (3) subjects will be treated with a single IV administration of 2 x 10\^7 (20 million) BMMSCs delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Pilot Phase: Group 3 (UCMSCs - 100 Million)
n=3 participants at risk
Three (3) subjects will be treated with a single IV administration of 1 x 10\^8 (100 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
|
Pilot Phase: Group 4 (BMMSCs -100 Million)
n=3 participants at risk
Three (3) subjects will be treated with a single IV administration of 1 x 10\^8 (100 million) BMMSCs delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Group A (UCMSCs - 100 Million)
Participants randomized to receive a single administration of 1 x 10\^8 (100 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
|
Group B (BMMSCs - 100 Million)
n=2 participants at risk
Participants randomized to receive a single administration of 1 x 10\^8 (100 million) BMMSC delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Group C (Placebo)
Participants randomized to receive a single administration of placebo via peripheral intravenous infusion.
Placebo: a single administration of placebo delivered via peripheral intravenous infusion.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Esophageal Perforation
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Infections and infestations
Sepsis
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
Other adverse events
| Measure |
Pilot Phase: Group 1 (UCMSCs - 20 Million)
n=3 participants at risk
Three (3) subjects will be treated with a single administration of 2 x 10\^7 (20 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
|
Pilot Phase: Group 2 (BMMSCs - 20 Million)
n=3 participants at risk
Three (3) subjects will be treated with a single IV administration of 2 x 10\^7 (20 million) BMMSCs delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Pilot Phase: Group 3 (UCMSCs - 100 Million)
n=3 participants at risk
Three (3) subjects will be treated with a single IV administration of 1 x 10\^8 (100 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
|
Pilot Phase: Group 4 (BMMSCs -100 Million)
n=3 participants at risk
Three (3) subjects will be treated with a single IV administration of 1 x 10\^8 (100 million) BMMSCs delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Group A (UCMSCs - 100 Million)
Participants randomized to receive a single administration of 1 x 10\^8 (100 million) UCMSCs delivered via peripheral intravenous infusion.
UCMSCs: Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
|
Group B (BMMSCs - 100 Million)
n=2 participants at risk
Participants randomized to receive a single administration of 1 x 10\^8 (100 million) BMMSC delivered via peripheral intravenous infusion.
BMMSCs: Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
|
Group C (Placebo)
Participants randomized to receive a single administration of placebo via peripheral intravenous infusion.
Placebo: a single administration of placebo delivered via peripheral intravenous infusion.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Infections and infestations
Urinary Tract Infection
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Infections and infestations
Pneumonia
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Infections and infestations
Upper Respiratory Infection
|
100.0%
3/3 • Number of events 3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
66.7%
2/3 • Number of events 3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
66.7%
2/3 • Number of events 2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Infections and infestations
Lower Respiratory Infection
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Injury, poisoning and procedural complications
Ecchymosis
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Blood and lymphatic system disorders
Anemia
|
66.7%
2/3 • Number of events 2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Blood and lymphatic system disorders
Monoclonal Gammopathy of Uncertain Significance
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Cardiac disorders
Congestive Heart Falure
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Cardiac disorders
Atrial Fibrillation
|
33.3%
1/3 • Number of events 2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Eye disorders
Periorbital Hematoma
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Endocrine disorders
Hypothyroidism
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Endocrine disorders
Diabetes Mellitus Type 2
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Injury, poisoning and procedural complications
Injured Ankle
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Injury, poisoning and procedural complications
Toenail Avulsion
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Injury, poisoning and procedural complications
Toe Fracture
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
50.0%
1/2 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Investigations
Creatinine Elevation
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Investigations
Liver Enzyme Elevation
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Investigations
Weight Gain
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Musculoskeletal and connective tissue disorders
Left Foot Osteomyelitis
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Musculoskeletal and connective tissue disorders
Lump on Elbow
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Musculoskeletal and connective tissue disorders
RIght Leg Pain
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Musculoskeletal and connective tissue disorders
Low Back Pain
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Musculoskeletal and connective tissue disorders
Rupture of Left Distal Biceps Tendon
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous Cell Carcinoma
|
66.7%
2/3 • Number of events 2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Nervous system disorders
Vocal Cord Paralysis
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Nervous system disorders
Vasovagal Syncope
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Nervous system disorders
Migrane Exacerbation
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Renal and urinary disorders
Microhematuria
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Renal and urinary disorders
Proteinuria
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Skin and subcutaneous tissue disorders
Diabetic Left Foot Ulcers
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Skin and subcutaneous tissue disorders
Scalp Acne
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Vascular disorders
Peripheral Vascular Disease
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Vascular disorders
Pseudoaneurysm of Right Femoral Artery
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Vascular disorders
Elevated Blood Pressure
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
|
Vascular disorders
Left Arm Hematoma
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/3 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
33.3%
1/3 • Number of events 1 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
0.00%
0/2 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
—
0/0 • 1 year
No subjects had been randomized to Group A or C at the time of trial termination.
|
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