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

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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 Company, LLC

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

Participant Flow

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
Arm/Group Description	Participants will receive an inject...	Participants will receive an inject...
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

Baseline Characteristics

Arm/Group Title		Allo-hMSCs	Auto-hMSCs	Total
Arm/Group Description		Participants will receive an inject...	Participants will receive an inject...	Total of all reporting groups
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
Baseline Analysis Population Description		[Not Specified]
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
United States		15	15	30

Outcome Measures

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
Description	[Not Specified]
Description	[Not Specified]
Time Frame	One month post-catheterization

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Allo-hMSCs	Auto-hMSCs
Arm/Group Description:	Participants will receive an inject...	Participants will receive an inject...
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)

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
Description	Percentage change from 13-months post-catheterization to baseline.
Description	Percentage change from 13-months post-catheterization to baseline.
Time Frame	Baseline Month 13 post-catheterization

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Allo-hMSCs	Auto-hMSCs
Arm/Group Description:	Participants will receive an inject...	Participants will receive an inject...
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)

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
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline Month 13 post-catheterization

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Allo-hMSCs	Auto-hMSCs
Arm/Group Description:	Participants will receive an inject...	Participants will receive an inject...
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)

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
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline Month 13 post-catheterization

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Allo-hMSCs	Auto-hMSCs
Arm/Group Description:	Participants will receive an inject...	Participants will receive an inject...
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)

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
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline Month 13 post-catheterization

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Allo-hMSCs	Auto-hMSCs
Arm/Group Description:	Participants will receive an inject...	Participants will receive an inject...
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)

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
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Baseline Month 13 post-catheterization

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Allo-hMSCs	Auto-hMSCs
Arm/Group Description:	Participants will receive an inject...	Participants will receive an inject...
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)

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.
Description	[Not Specified]
Description	[Not Specified]
Time Frame	12-months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Allo-hMSCs	Auto-hMSCs
Arm/Group Description:	Participants will receive an inject...	Participants will receive an inject...
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)

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
Description	The Minnesota living with heart failure questionnaire uses a 6-point, ...
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

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Allo-hMSCs	Auto-hMSCs
Arm/Group Description:	Participants will receive an inject...	Participants will receive an inject...
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)

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
Description	[Not Specified]
Description	[Not Specified]
Time Frame	12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	Allo-hMSCs	Auto-hMSCs
Arm/Group Description:	Participants will receive an inject...	Participants will receive an inject...
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

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]

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	Adverse events are shown by organ system.

Arm/Group Title	Allo-hMSCs		Auto-hMSCs
Arm/Group Description	Participants will receive an inject...		Participants will receive an inject...
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	--/--		--/--
Serious Adverse Events 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
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)

Limitations and Caveats

[Not Specified]

More Information

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

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Name/Title:	Adam Mendizabal
Organization:	The EMMES Corporation
Phone:	301 251 1161 ext 221
EMail:	amendizabal@emmes.com

Publications of Results:

Hare JM, Fishman JE, Gerstenblith G, DiFede Velazquez DL, Zambrano JP, Suncion VY, Tracy M, Ghersin E, Johnston PV, Brinker JA, Breton E, Davis-Sproul J, Schulman IH, Byrnes J, Mendizabal AM, Lowery MH, Rouy D, Altman P, Wong Po Foo C, Ruiz P, Amador A, Da Silva J, McNiece IK, Heldman AW, George R, Lardo A. Comparison of allogeneic vs autologous bone marrow-derived mesenchymal stem cells delivered by transendocardial injection in patients with ischemic cardiomyopathy: the POSEIDON randomized trial. JAMA. 2012 Dec 12;308(22):2369-79. Erratum in: JAMA. 2013 Aug 21;310(7):750. George, Richard [added]; Lardo, Albert [added].

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tompkins BA, Rieger AC, Florea V, Banerjee MN, Natsumeda M, Nigh ED, Landin AM, Rodriguez GM, Hatzistergos KE, Schulman IH, Hare JM. Comparison of Mesenchymal Stem Cell Efficacy in Ischemic Versus Nonischemic Dilated Cardiomyopathy. J Am Heart Assoc. 2018 Jul 12;7(14). pii: e008460. doi: 10.1161/JAHA.117.008460.

Layout table for additonal information

Responsible Party:	Joshua M Hare, University of Miami
ClinicalTrials.gov Identifier:	NCT01087996
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

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