Trial Outcomes & Findings for PercutaneOus StEm Cell Injection Delivery Effects On Neomyogenesis in Dilated CardioMyopathy (The POSEIDON-DCM Study) (NCT NCT01392625)
NCT ID: NCT01392625
Last Updated: 2018-02-15
Results Overview
Incidence of TE-SAEs is defined as the composite of: death, non-fatal MI, stroke, hospitalization for worsening heart failure, cardiac perforation, pericardial tamponade, sustained ventricular arrhythmias (characterized by ventricular arrhythmias lasting longer than 15 seconds or with hemodynamic compromise), or any other potential late effects detected and corroborated by clinical presentation, laboratory investigations, image analysis and when necessary with biopsy from suspected target sites in the body.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
37 participants
Primary outcome timeframe
One month post-catheterization
Results posted on
2018-02-15
Participant Flow
Participant milestones
| Measure |
Autologous hMSCs
Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:
Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
|
Allogeneic hMSCs
Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:
Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
|
|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
|
Overall Study
COMPLETED
|
16
|
18
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
37 participants were randomized to treatment numbers and assignments but 3 did not continue with treatment and not included in the analysis.
Baseline characteristics by cohort
| Measure |
Autologous hMSCs
n=18 Participants
Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:
Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
|
Allogeneic hMSCs
n=19 Participants
Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:
Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.4 years
STANDARD_DEVIATION 11.0 • n=18 Participants
|
54.4 years
STANDARD_DEVIATION 11.5 • n=19 Participants
|
55.8 years
STANDARD_DEVIATION 11.2 • n=37 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=18 Participants
|
5 Participants
n=19 Participants
|
12 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=18 Participants
|
14 Participants
n=19 Participants
|
25 Participants
n=37 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=18 Participants
|
4 Participants
n=19 Participants
|
12 Participants
n=37 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=18 Participants
|
15 Participants
n=19 Participants
|
25 Participants
n=37 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=18 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=18 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=18 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=18 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=18 Participants
|
2 Participants
n=19 Participants
|
3 Participants
n=37 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=18 Participants
|
17 Participants
n=19 Participants
|
33 Participants
n=37 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=18 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=37 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=18 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=37 Participants
|
|
Participants Injection status in the trial
No
|
2 Participants
n=18 Participants
|
1 Participants
n=19 Participants
|
3 Participants
n=37 Participants
|
|
Participants Injection status in the trial
Yes
|
16 Participants
n=18 Participants
|
18 Participants
n=19 Participants
|
34 Participants
n=37 Participants
|
|
Participants Ejection Fraction % in the trial
|
21.7 percentage
STANDARD_DEVIATION 6.2 • n=18 Participants
|
22.5 percentage
STANDARD_DEVIATION 6.5 • n=19 Participants
|
22.1 percentage
STANDARD_DEVIATION 6.3 • n=37 Participants
|
|
Enrollment End Diastolic diameter (CM)
|
7.0 centimeters
STANDARD_DEVIATION 1.6 • n=18 Participants
|
7.2 centimeters
STANDARD_DEVIATION 1.2 • n=19 Participants
|
7.1 centimeters
STANDARD_DEVIATION 1.4 • n=37 Participants
|
|
New York Heart Association Class
Class I - no limitation
|
6 Participants
n=16 Participants • 37 participants were randomized to treatment numbers and assignments but 3 did not continue with treatment and not included in the analysis.
|
4 Participants
n=18 Participants • 37 participants were randomized to treatment numbers and assignments but 3 did not continue with treatment and not included in the analysis.
|
10 Participants
n=34 Participants • 37 participants were randomized to treatment numbers and assignments but 3 did not continue with treatment and not included in the analysis.
|
|
New York Heart Association Class
Class II - Slight Limitation of Physical Activity
|
8 Participants
n=16 Participants • 37 participants were randomized to treatment numbers and assignments but 3 did not continue with treatment and not included in the analysis.
|
9 Participants
n=18 Participants • 37 participants were randomized to treatment numbers and assignments but 3 did not continue with treatment and not included in the analysis.
|
17 Participants
n=34 Participants • 37 participants were randomized to treatment numbers and assignments but 3 did not continue with treatment and not included in the analysis.
|
|
New York Heart Association Class
Class III - Marked Limitation of Physical Activity
|
2 Participants
n=16 Participants • 37 participants were randomized to treatment numbers and assignments but 3 did not continue with treatment and not included in the analysis.
|
5 Participants
n=18 Participants • 37 participants were randomized to treatment numbers and assignments but 3 did not continue with treatment and not included in the analysis.
|
7 Participants
n=34 Participants • 37 participants were randomized to treatment numbers and assignments but 3 did not continue with treatment and not included in the analysis.
|
|
New York Heart Association Class
Class IV -Inability to carry on physical activity
|
0 Participants
n=16 Participants • 37 participants were randomized to treatment numbers and assignments but 3 did not continue with treatment and not included in the analysis.
|
0 Participants
n=18 Participants • 37 participants were randomized to treatment numbers and assignments but 3 did not continue with treatment and not included in the analysis.
|
0 Participants
n=34 Participants • 37 participants were randomized to treatment numbers and assignments but 3 did not continue with treatment and not included in the analysis.
|
PRIMARY outcome
Timeframe: One month post-catheterizationIncidence of TE-SAEs is defined as the composite of: death, non-fatal MI, stroke, hospitalization for worsening heart failure, cardiac perforation, pericardial tamponade, sustained ventricular arrhythmias (characterized by ventricular arrhythmias lasting longer than 15 seconds or with hemodynamic compromise), or any other potential late effects detected and corroborated by clinical presentation, laboratory investigations, image analysis and when necessary with biopsy from suspected target sites in the body.
Outcome measures
| Measure |
Autologous hMSCs
n=16 Participants
Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:
Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
|
Allogeneic hMSCs
n=18 Participants
Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:
Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
|
|---|---|---|
|
Incidence of Any Treatment-emergent Serious Adverse Events (TE-SAEs)
Upper respiratory tract infection
|
1 Participants
|
0 Participants
|
|
Incidence of Any Treatment-emergent Serious Adverse Events (TE-SAEs)
Ventricular tachycardia
|
0 Participants
|
1 Participants
|
|
Incidence of Any Treatment-emergent Serious Adverse Events (TE-SAEs)
Device Pacing issue
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 month and 12 monthMeasurement of Peak oxygen consumption (Peak VO2) by treadmill determination during the 12 month follow-up period.
Outcome measures
| Measure |
Autologous hMSCs
n=16 Participants
Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:
Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
|
Allogeneic hMSCs
n=18 Participants
Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:
Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
|
|---|---|---|
|
Measurement of Changes in Peak VO2
Peak VO2 (Baseline)
|
16.0 ml/kg/min
Standard Deviation 5.13
|
17.9 ml/kg/min
Standard Deviation 5.17
|
|
Measurement of Changes in Peak VO2
Peak VO2 (6 months)
|
15.5 ml/kg/min
Standard Deviation 6.62
|
17.6 ml/kg/min
Standard Deviation 3.55
|
|
Measurement of Changes in Peak VO2
Peak VO2 (1 year)
|
16.4 ml/kg/min
Standard Deviation 3.92
|
20.1 ml/kg/min
Standard Deviation 5.10
|
SECONDARY outcome
Timeframe: Baseline, 6 month and 12 monthMeasurement of Six-minute walk test during the 12 month follow-up period
Outcome measures
| Measure |
Autologous hMSCs
n=16 Participants
Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:
Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
|
Allogeneic hMSCs
n=18 Participants
Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:
Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
|
|---|---|---|
|
Measurement of Changes in 6 Minute Walk
6 minute walk (Baseline)
|
416.4 meters
Standard Deviation 105.74
|
427.2 meters
Standard Deviation 67.35
|
|
Measurement of Changes in 6 Minute Walk
6 minute walk (6 months)
|
384.2 meters
Standard Deviation 106.96
|
438.7 meters
Standard Deviation 106.53
|
|
Measurement of Changes in 6 Minute Walk
6 minute walk (1 year)
|
32.3 meters
Standard Deviation 12.71
|
35.1 meters
Standard Deviation 13.59
|
SECONDARY outcome
Timeframe: Baseline, 6 month and 12 monthMeasurement of regional left ventricular function, end diastolic and end systolic volume, measured by MRI, and or CT, and echocardiogram.
Outcome measures
| Measure |
Autologous hMSCs
n=16 Participants
Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:
Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
|
Allogeneic hMSCs
n=18 Participants
Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:
Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
|
|---|---|---|
|
Measurement of Changes in Global Ejection Fraction
Global ejection fraction (Baseline)
|
25.2 % ratio of the SV to Global EDV
Standard Deviation 10.49
|
37.6 % ratio of the SV to Global EDV
Standard Deviation 9.03
|
|
Measurement of Changes in Global Ejection Fraction
Global ejection fraction (1 year)
|
32.3 % ratio of the SV to Global EDV
Standard Deviation 12.71
|
35.1 % ratio of the SV to Global EDV
Standard Deviation 13.59
|
SECONDARY outcome
Timeframe: Baseline, 6 month and 12 monthMeasurement of New York Heart Association (NYHA) functional class during the 12 month follow-up period.
Outcome measures
| Measure |
Autologous hMSCs
n=18 Participants
Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:
Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
|
Allogeneic hMSCs
n=19 Participants
Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:
Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
|
|---|---|---|
|
Measurement of Changes in New York Heart Association (NYHA)
NYHA Class 1 (6 month)
|
8 Participants
|
12 Participants
|
|
Measurement of Changes in New York Heart Association (NYHA)
NYHA Class 1 (Baseline)
|
6 Participants
|
4 Participants
|
|
Measurement of Changes in New York Heart Association (NYHA)
NYHA Class 2 (Baseline)
|
8 Participants
|
9 Participants
|
|
Measurement of Changes in New York Heart Association (NYHA)
NYHA Class 3 (Baseline)
|
2 Participants
|
5 Participants
|
|
Measurement of Changes in New York Heart Association (NYHA)
NYHA Class 2 (6 month)
|
6 Participants
|
4 Participants
|
|
Measurement of Changes in New York Heart Association (NYHA)
NYHA Class 3 (6 month)
|
1 Participants
|
1 Participants
|
|
Measurement of Changes in New York Heart Association (NYHA)
NYHA Class 1 (12 month)
|
7 Participants
|
14 Participants
|
|
Measurement of Changes in New York Heart Association (NYHA)
NYHA Class 2 (12 month)
|
2 Participants
|
1 Participants
|
|
Measurement of Changes in New York Heart Association (NYHA)
NYHA Class 3 (12 month)
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, 6 month and 12 monthMeasurement of Minnesota Living with Heart Failure (MLHF) Questionnaire during the 12 month follow-up period. It measures the effects of symptoms, functional limitations, and psychological distress on an individual's quality of life. The response scale for all 21 items on the MLHF is based on a 6-point. The Maximum possible scores being 126 and the minimum 0. Higher scores indicate a worse or worsening quality of life, while lower scores or decreasing scores indicate a better quality of life.
Outcome measures
| Measure |
Autologous hMSCs
n=16 Participants
Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:
Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
|
Allogeneic hMSCs
n=18 Participants
Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:
Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
|
|---|---|---|
|
Measurement of Changes in Minnesota Living With Heart Failure (MLHF) Questionnaire
MLHF (Baseline)
|
30.5 scores on a scale
Interval 5.0 to 80.0
|
38.0 scores on a scale
Interval 10.0 to 82.0
|
|
Measurement of Changes in Minnesota Living With Heart Failure (MLHF) Questionnaire
MLHF (6 month)
|
35 scores on a scale
Interval 0.0 to 87.0
|
18 scores on a scale
Interval 0.0 to 68.0
|
|
Measurement of Changes in Minnesota Living With Heart Failure (MLHF) Questionnaire
MLHF (12 month)
|
9.0 scores on a scale
Interval 0.0 to 41.0
|
12.0 scores on a scale
Interval 0.0 to 51.0
|
Adverse Events
Autologous hMSCs
Serious events: 6 serious events
Other events: 4 other events
Deaths: 2 deaths
Allogeneic hMSCs
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Autologous hMSCs
n=18 participants at risk
Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:
Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
|
Allogeneic hMSCs
n=19 participants at risk
Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:
Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
|
|---|---|---|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/18 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
5.3%
1/19 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
1/18 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
0.00%
0/19 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
|
Product Issues
Device Pacing issue
|
0.00%
0/18 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
5.3%
1/19 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/18 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
5.3%
1/19 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
|
Cardiac disorders
Cardiac failure
|
11.1%
2/18 • Number of events 3 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
5.3%
1/19 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
|
Cardiac disorders
Coronary artery disease
|
5.6%
1/18 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
0.00%
0/19 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
|
Gastrointestinal disorders
Gatrooesophageal reflux disease
|
0.00%
0/18 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
5.3%
1/19 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
|
Injury, poisoning and procedural complications
Subdural heamatoma
|
5.6%
1/18 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
0.00%
0/19 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
|
Nervous system disorders
Syncope
|
5.6%
1/18 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
0.00%
0/19 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
|
Product Issues
Device pacing issues
|
0.00%
0/18 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
5.3%
1/19 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/18 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
5.3%
1/19 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/18 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
5.3%
1/19 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
Other adverse events
| Measure |
Autologous hMSCs
n=18 participants at risk
Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
Autologous hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:
Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
|
Allogeneic hMSCs
n=19 participants at risk
Group 2 (18 patients) Eighteen (18) patients will be treated with allogeneic hMSCs (Allo-hMSCs): 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
Allogeneic hMSCs: Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:
Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/18 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
5.3%
1/19 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
|
Cardiac disorders
Mitral valve incompetence
|
5.6%
1/18 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
0.00%
0/19 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/18 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
5.3%
1/19 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
|
General disorders
Adverse drug reaction
|
0.00%
0/18 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
5.3%
1/19 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
|
General disorders
Chest Discomfort
|
0.00%
0/18 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
5.3%
1/19 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
1/18 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
5.3%
1/19 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/18 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
5.3%
1/19 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/18 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
5.3%
1/19 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
|
Investigations
Weight increased
|
11.1%
2/18 • Number of events 2 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
0.00%
0/19 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/18 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
5.3%
1/19 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
|
Nervous system disorders
Migraine
|
0.00%
0/18 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
5.3%
1/19 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
|
Product Issues
Device pacing issue
|
0.00%
0/18 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
5.3%
1/19 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.6%
1/18 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
0.00%
0/19 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.6%
1/18 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
0.00%
0/19 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
|
Surgical and medical procedures
Implantable defibrillator insertion
|
0.00%
0/18 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
5.3%
1/19 • Number of events 1 • These AE's were collected over a period of 1 year from the subject signing the consent form.
|
Additional Information
Joshua M. Hare, MD
ISCI / University of Miami Miller School of Medicine
Phone: 305-243-5579
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place