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The Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis Pilot Study (The POSEIDON-Pilot Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01087996
Recruitment Status : Completed
First Posted : March 16, 2010
Results First Posted : May 27, 2015
Last Update Posted : May 27, 2015
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
The EMMES Corporation
Information provided by (Responsible Party):
Joshua M Hare, University of Miami

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Stem Cell Transplantation
Interventions Biological: Auto-hMSCs
Biological: Allo-hMSCs
Enrollment 31
Recruitment Details Participants were enrolled between April 2, 2010 and September 14, 2011
Pre-assignment Details One patient did not receive Autologous MSCs because they became ineligible.
Arm/Group Title Allo-hMSCs Auto-hMSCs
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 15 15
Completed 15 15
Not Completed 0 0
Arm/Group Title Allo-hMSCs Auto-hMSCs Total
Hide Arm/Group Description

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 15 15 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
9
  60.0%
5
  33.3%
14
  46.7%
>=65 years
6
  40.0%
10
  66.7%
16
  53.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 15 participants 30 participants
62.8  (10.5) 63.7  (9.3) 63.2  (9.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 15 participants 30 participants
Female
2
  13.3%
2
  13.3%
4
  13.3%
Male
13
  86.7%
13
  86.7%
26
  86.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 15 participants 15 participants 30 participants
15 15 30
1.Primary Outcome
Title 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
Hide Description [Not Specified]
Time Frame One month post-catheterization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allo-hMSCs Auto-hMSCs
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 15 15
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
6.70
(1.70 to 31.95)
6.70
(1.70 to 31.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-hMSCs, Auto-hMSCs
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.00
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title CT Infarct Size From Early Enhanced Defect: - Difference Between the Baseline and 13-month
Hide Description Percentage change from 13-months post-catheterization to baseline.
Time Frame Baseline Month 13 post-catheterization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allo-hMSCs Auto-hMSCs
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 15 15
Mean (95% Confidence Interval)
Unit of Measure: percent change from baseline
-31.61
(-49.24 to -13.99)
-34.93
(-48.18 to -21.68)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-hMSCs, Auto-hMSCs
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.75
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
3.Secondary Outcome
Title CT Measure of Left Ventricular Ejection Fraction
Hide Description [Not Specified]
Time Frame Baseline Month 13 post-catheterization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allo-hMSCs Auto-hMSCs
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 15 15
Mean (95% Confidence Interval)
Unit of Measure: percent
Baseline
27.85
(22.30 to 33.41)
26.23
(20.26 to 32.20)
13-Month
29.50
(24.10 to 34.90)
28.53
(23.40 to 33.66)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-hMSCs, Auto-hMSCs
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
4.Secondary Outcome
Title CT Measure of End Diastolic Volume
Hide Description [Not Specified]
Time Frame Baseline Month 13 post-catheterization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allo-hMSCs Auto-hMSCs
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 15 15
Mean (95% Confidence Interval)
Unit of Measure: ml
Baseline
260.26
(211.21 to 309.31)
300.89
(251.33 to 350.45)
13-Month
243.66
(200.17 to 287.14)
291.75
(235.45 to 348.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-hMSCs, Auto-hMSCs
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
5.Secondary Outcome
Title CT Measure of End Systolic Volume
Hide Description [Not Specified]
Time Frame Baseline Month 13 post-catheterization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allo-hMSCs Auto-hMSCs
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 15 15
Mean (95% Confidence Interval)
Unit of Measure: ml
Baseline
191.95
(145.77 to 238.12)
225.67
(178.46 to 272.88)
13-Month
175.99
(135.21 to 216.46)
213.59
(164.26 to 262.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-hMSCs, Auto-hMSCs
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Secondary Outcome
Title CT Measure of Scar Size as % of LV Mass
Hide Description [Not Specified]
Time Frame Baseline Month 13 post-catheterization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allo-hMSCs Auto-hMSCs
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 15 15
Mean (95% Confidence Interval)
Unit of Measure: percent
Baseline
9.40
(7.11 to 11.68)
10.71
(6.99 to 14.43)
Month 13
5.54
(3.92 to 7.16)
5.92
(4.16 to 7.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-hMSCs, Auto-hMSCs
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
7.Secondary Outcome
Title Change in Distance Walked in 6-minutes From Baseline.
Hide Description [Not Specified]
Time Frame 12-months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allo-hMSCs Auto-hMSCs
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 15 15
Mean (95% Confidence Interval)
Unit of Measure: meters
19.7
(-19.0 to 58.3)
65.8
(27.2 to 104.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-hMSCs, Auto-hMSCs
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method Repeated measures ANOVA
Comments [Not Specified]
8.Secondary Outcome
Title Change in Minnesota Living With Heart Failure Total Score
Hide Description The 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.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allo-hMSCs Auto-hMSCs
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 15 15
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-10.2
(-31.1 to 10.7)
-13.0
(-22.6 to -3.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-hMSCs, Auto-hMSCs
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.84
Comments [Not Specified]
Method Repeated measures ANOVA
Comments [Not Specified]
9.Secondary Outcome
Title Change in New York Heart Association Class at 12-months
Hide Description [Not Specified]
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Allo-hMSCs Auto-hMSCs
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 14 14
Measure Type: Number
Unit of Measure: participants
Improved NYHA Class 4 7
No change in NYHA Class 8 6
Worsened NYHA Class 2 1
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Allo-hMSCs, Auto-hMSCs
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse events are shown by organ system.
 
Arm/Group Title Allo-hMSCs Auto-hMSCs
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Allo-hMSCs Auto-hMSCs
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Allo-hMSCs Auto-hMSCs
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/15 (33.33%)      8/15 (53.33%)    
Cardiac disorders     
Cardiac Disorders * 1  3/15 (20.00%)  3 7/15 (46.67%)  7
Gastrointestinal disorders     
Gastrointestinal disorder * 1  1/15 (6.67%)  1 1/15 (6.67%)  1
Infections and infestations     
Infections and infestations * 1  1/15 (6.67%)  1 0/15 (0.00%)  0
Nervous system disorders     
Nervous System Disorder * 1  0/15 (0.00%)  0 1/15 (6.67%)  1
Renal and urinary disorders     
Renal and Urinary Disorders * 1  0/15 (0.00%)  0 1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders     
Respiratory, Thoracic, and mediastinal disorders * 1  1/15 (6.67%)  1 1/15 (6.67%)  1
Surgical and medical procedures     
Surgical and Medical Procedure * 1  0/15 (0.00%)  0 1/15 (6.67%)  1
Vascular disorders     
Vascular Disorders * 1  1/15 (6.67%)  1 0/15 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 10.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Allo-hMSCs Auto-hMSCs
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/15 (66.67%)      11/15 (73.33%)    
Cardiac disorders     
cardiac disorder * 1  6/15 (40.00%)  6 7/15 (46.67%)  7
Eye disorders     
Eye Disorders * 1  1/15 (6.67%)  1 0/15 (0.00%)  0
Gastrointestinal disorders     
Gastrointestinal disorders * 1  1/15 (6.67%)  1 3/15 (20.00%)  3
General disorders     
General disorders and administration site conditions * 1  1/15 (6.67%)  1 2/15 (13.33%)  2
Infections and infestations     
Infections and infestations * 1  3/15 (20.00%)  3 2/15 (13.33%)  2
Injury, poisoning and procedural complications     
Injury, poisoning and procedural complications * 1  2/15 (13.33%)  2 0/15 (0.00%)  0
Metabolism and nutrition disorders     
Metabolism and nutrition disorders * 1  2/15 (13.33%)  2 0/15 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Musculoskeletal and connective issue disorders * 1  0/15 (0.00%)  0 2/15 (13.33%)  2
Nervous system disorders     
Nervous System Disorders * 1  0/15 (0.00%)  0 4/15 (26.67%)  4
Renal and urinary disorders     
Renal and urinary disorders * 1  0/15 (0.00%)  0 1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders     
Respiratory, thoracic and mediastinal disorders * 1  2/15 (13.33%)  2 1/15 (6.67%)  1
Skin and subcutaneous tissue disorders     
Skin and subcutaneous disorders * 1  0/15 (0.00%)  0 1/15 (6.67%)  1
Vascular disorders     
vascular disorders * 1  2/15 (13.33%)  2 1/15 (6.67%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Adam Mendizabal
Organization: The EMMES Corporation
Phone: 301 251 1161 ext 221
Responsible Party: Joshua M Hare, University of Miami
ClinicalTrials.gov Identifier: NCT01087996     History of Changes
Other Study ID Numbers: 20090352
R01HL110737 ( U.S. NIH Grant/Contract )
R01HL107110 ( U.S. NIH Grant/Contract )
R01HL084275 ( U.S. NIH Grant/Contract )
P20HL101443 ( U.S. NIH Grant/Contract )
R01HL094849 ( U.S. NIH Grant/Contract )
First Submitted: March 15, 2010
First Posted: March 16, 2010
Results First Submitted: August 30, 2013
Results First Posted: May 27, 2015
Last Update Posted: May 27, 2015