Trial Outcomes & Findings for The Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis Pilot Study (The POSEIDON-Pilot Study) (NCT NCT01087996)
NCT ID: NCT01087996
Last Updated: 2015-05-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
31 participants
Primary outcome timeframe
One month post-catheterization
Results posted on
2015-05-27
Participant Flow
Participants were enrolled between April 2, 2010 and September 14, 2011
One patient did not receive Autologous MSCs because they became ineligible.
Participant milestones
| Measure |
Allo-hMSCs
Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.
Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10\^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10\^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10\^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
|
Auto-hMSCs
Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.
Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10\^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10\^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10\^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
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|---|---|---|
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Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis Pilot Study (The POSEIDON-Pilot Study)
Baseline characteristics by cohort
| Measure |
Allo-hMSCs
n=15 Participants
Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.
Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10\^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10\^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10\^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
|
Auto-hMSCs
n=15 Participants
Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.
Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10\^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10\^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10\^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
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Total
n=30 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
63.7 years
STANDARD_DEVIATION 9.3 • n=7 Participants
|
63.2 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One month post-catheterizationOutcome measures
| Measure |
Allo-hMSCs
n=15 Participants
Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.
Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10\^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10\^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10\^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
|
Auto-hMSCs
n=15 Participants
Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.
Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10\^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10\^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10\^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
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|---|---|---|
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Incidence of TE-SAE Define as Composite of Death, Non-fatal MI, Stroke, Hospitalization for Worsening Heart Failure, Cardiac Perforation, Pericardial Tamponade, Ventricular Arrhythmias >15 Sec. or With Hemodynamic Compromise or Atrial Fibrillation
|
6.70 percentage of participants
Interval 1.7 to 31.95
|
6.70 percentage of participants
Interval 1.7 to 31.95
|
SECONDARY outcome
Timeframe: Baseline Month 13 post-catheterizationPercentage change from 13-months post-catheterization to baseline.
Outcome measures
| Measure |
Allo-hMSCs
n=15 Participants
Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.
Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10\^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10\^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10\^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
|
Auto-hMSCs
n=15 Participants
Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.
Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10\^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10\^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10\^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
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|---|---|---|
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CT Infarct Size From Early Enhanced Defect: - Difference Between the Baseline and 13-month
|
-31.61 percent change from baseline
Interval -49.24 to -13.99
|
-34.93 percent change from baseline
Interval -48.18 to -21.68
|
SECONDARY outcome
Timeframe: Baseline Month 13 post-catheterizationOutcome measures
| Measure |
Allo-hMSCs
n=15 Participants
Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.
Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10\^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10\^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10\^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
|
Auto-hMSCs
n=15 Participants
Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.
Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10\^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10\^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10\^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
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|---|---|---|
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CT Measure of Left Ventricular Ejection Fraction
Baseline
|
27.85 percent
Interval 22.3 to 33.41
|
26.23 percent
Interval 20.26 to 32.2
|
|
CT Measure of Left Ventricular Ejection Fraction
13-Month
|
29.50 percent
Interval 24.1 to 34.9
|
28.53 percent
Interval 23.4 to 33.66
|
SECONDARY outcome
Timeframe: Baseline Month 13 post-catheterizationOutcome measures
| Measure |
Allo-hMSCs
n=15 Participants
Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.
Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10\^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10\^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10\^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
|
Auto-hMSCs
n=15 Participants
Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.
Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10\^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10\^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10\^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
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|---|---|---|
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CT Measure of End Diastolic Volume
Baseline
|
260.26 ml
Interval 211.21 to 309.31
|
300.89 ml
Interval 251.33 to 350.45
|
|
CT Measure of End Diastolic Volume
13-Month
|
243.66 ml
Interval 200.17 to 287.14
|
291.75 ml
Interval 235.45 to 348.05
|
SECONDARY outcome
Timeframe: Baseline Month 13 post-catheterizationOutcome measures
| Measure |
Allo-hMSCs
n=15 Participants
Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.
Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10\^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10\^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10\^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
|
Auto-hMSCs
n=15 Participants
Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.
Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10\^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10\^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10\^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
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|---|---|---|
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CT Measure of End Systolic Volume
Baseline
|
191.95 ml
Interval 145.77 to 238.12
|
225.67 ml
Interval 178.46 to 272.88
|
|
CT Measure of End Systolic Volume
13-Month
|
175.99 ml
Interval 135.21 to 216.46
|
213.59 ml
Interval 164.26 to 262.93
|
SECONDARY outcome
Timeframe: Baseline Month 13 post-catheterizationOutcome measures
| Measure |
Allo-hMSCs
n=15 Participants
Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.
Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10\^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10\^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10\^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
|
Auto-hMSCs
n=15 Participants
Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.
Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10\^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10\^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10\^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
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|---|---|---|
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CT Measure of Scar Size as % of LV Mass
Baseline
|
9.40 percent
Interval 7.11 to 11.68
|
10.71 percent
Interval 6.99 to 14.43
|
|
CT Measure of Scar Size as % of LV Mass
Month 13
|
5.54 percent
Interval 3.92 to 7.16
|
5.92 percent
Interval 4.16 to 7.67
|
SECONDARY outcome
Timeframe: 12-monthsOutcome measures
| Measure |
Allo-hMSCs
n=15 Participants
Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.
Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10\^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10\^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10\^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
|
Auto-hMSCs
n=15 Participants
Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.
Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10\^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10\^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10\^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
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|---|---|---|
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Change in Distance Walked in 6-minutes From Baseline.
|
19.7 meters
Interval -19.0 to 58.3
|
65.8 meters
Interval 27.2 to 104.5
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SECONDARY outcome
Timeframe: 12 monthsThe Minnesota living with heart failure questionnaire uses a 6-point, zero to five, Likert scale. The total score is the sum of the 21 responses. The total score is considered the best measure of how heart failure and treatments impact a patients quality of life. The max score is 105, minimum score is 0. A lower score is considered a better quality of life.
Outcome measures
| Measure |
Allo-hMSCs
n=15 Participants
Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.
Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10\^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10\^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10\^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
|
Auto-hMSCs
n=15 Participants
Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.
Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10\^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10\^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10\^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
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|---|---|---|
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Change in Minnesota Living With Heart Failure Total Score
|
-10.2 units on a scale
Interval -31.1 to 10.7
|
-13.0 units on a scale
Interval -22.6 to -3.3
|
SECONDARY outcome
Timeframe: 12 monthsOutcome measures
| Measure |
Allo-hMSCs
n=14 Participants
Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.
Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10\^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10\^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10\^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
|
Auto-hMSCs
n=14 Participants
Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.
Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10\^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10\^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10\^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
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|---|---|---|
|
Change in New York Heart Association Class at 12-months
Improved NYHA Class
|
4 participants
|
7 participants
|
|
Change in New York Heart Association Class at 12-months
No change in NYHA Class
|
8 participants
|
6 participants
|
|
Change in New York Heart Association Class at 12-months
Worsened NYHA Class
|
2 participants
|
1 participants
|
Adverse Events
Allo-hMSCs
Serious events: 5 serious events
Other events: 10 other events
Deaths: 0 deaths
Auto-hMSCs
Serious events: 8 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Allo-hMSCs
n=15 participants at risk
Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.
Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10\^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10\^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10\^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
|
Auto-hMSCs
n=15 participants at risk
Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.
Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10\^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10\^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10\^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
|
|---|---|---|
|
Cardiac disorders
Cardiac Disorders
|
20.0%
3/15 • Number of events 3
Adverse events are shown by organ system.
|
46.7%
7/15 • Number of events 7
Adverse events are shown by organ system.
|
|
Nervous system disorders
Nervous System Disorder
|
0.00%
0/15
Adverse events are shown by organ system.
|
6.7%
1/15 • Number of events 1
Adverse events are shown by organ system.
|
|
Renal and urinary disorders
Renal and Urinary Disorders
|
0.00%
0/15
Adverse events are shown by organ system.
|
6.7%
1/15 • Number of events 1
Adverse events are shown by organ system.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic, and mediastinal disorders
|
6.7%
1/15 • Number of events 1
Adverse events are shown by organ system.
|
6.7%
1/15 • Number of events 1
Adverse events are shown by organ system.
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
6.7%
1/15 • Number of events 1
Adverse events are shown by organ system.
|
6.7%
1/15 • Number of events 1
Adverse events are shown by organ system.
|
|
Infections and infestations
Infections and infestations
|
6.7%
1/15 • Number of events 1
Adverse events are shown by organ system.
|
0.00%
0/15
Adverse events are shown by organ system.
|
|
Surgical and medical procedures
Surgical and Medical Procedure
|
0.00%
0/15
Adverse events are shown by organ system.
|
6.7%
1/15 • Number of events 1
Adverse events are shown by organ system.
|
|
Vascular disorders
Vascular Disorders
|
6.7%
1/15 • Number of events 1
Adverse events are shown by organ system.
|
0.00%
0/15
Adverse events are shown by organ system.
|
Other adverse events
| Measure |
Allo-hMSCs
n=15 participants at risk
Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.
Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10\^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10\^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10\^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
|
Auto-hMSCs
n=15 participants at risk
Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.
Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10\^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10\^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10\^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
|
|---|---|---|
|
Cardiac disorders
cardiac disorder
|
40.0%
6/15 • Number of events 6
Adverse events are shown by organ system.
|
46.7%
7/15 • Number of events 7
Adverse events are shown by organ system.
|
|
Eye disorders
Eye Disorders
|
6.7%
1/15 • Number of events 1
Adverse events are shown by organ system.
|
0.00%
0/15
Adverse events are shown by organ system.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
6.7%
1/15 • Number of events 1
Adverse events are shown by organ system.
|
20.0%
3/15 • Number of events 3
Adverse events are shown by organ system.
|
|
General disorders
General disorders and administration site conditions
|
6.7%
1/15 • Number of events 1
Adverse events are shown by organ system.
|
13.3%
2/15 • Number of events 2
Adverse events are shown by organ system.
|
|
Infections and infestations
Infections and infestations
|
20.0%
3/15 • Number of events 3
Adverse events are shown by organ system.
|
13.3%
2/15 • Number of events 2
Adverse events are shown by organ system.
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
13.3%
2/15 • Number of events 2
Adverse events are shown by organ system.
|
0.00%
0/15
Adverse events are shown by organ system.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
13.3%
2/15 • Number of events 2
Adverse events are shown by organ system.
|
0.00%
0/15
Adverse events are shown by organ system.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective issue disorders
|
0.00%
0/15
Adverse events are shown by organ system.
|
13.3%
2/15 • Number of events 2
Adverse events are shown by organ system.
|
|
Nervous system disorders
Nervous System Disorders
|
0.00%
0/15
Adverse events are shown by organ system.
|
26.7%
4/15 • Number of events 4
Adverse events are shown by organ system.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
0.00%
0/15
Adverse events are shown by organ system.
|
6.7%
1/15 • Number of events 1
Adverse events are shown by organ system.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
13.3%
2/15 • Number of events 2
Adverse events are shown by organ system.
|
6.7%
1/15 • Number of events 1
Adverse events are shown by organ system.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous disorders
|
0.00%
0/15
Adverse events are shown by organ system.
|
6.7%
1/15 • Number of events 1
Adverse events are shown by organ system.
|
|
Vascular disorders
vascular disorders
|
13.3%
2/15 • Number of events 2
Adverse events are shown by organ system.
|
6.7%
1/15 • Number of events 1
Adverse events are shown by organ system.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place