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

This study has been completed.
Sponsor:
Collaborators:
The EMMES Corporation
Information provided by (Responsible Party):
Joshua M Hare, University of Miami
ClinicalTrials.gov Identifier:
NCT01087996
First received: March 15, 2010
Last updated: May 21, 2015
Last verified: May 2015
Results First Received: August 30, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Stem Cell Transplantation
Interventions: Biological: Auto-hMSCs
Biological: Allo-hMSCs

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were enrolled between April 2, 2010 and September 14, 2011

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One patient did not receive Autologous MSCs because they became ineligible.

Reporting Groups
  Description
Allo-hMSCs

Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.

Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.

Auto-hMSCs

Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.

Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.


Participant Flow:   Overall Study
    Allo-hMSCs     Auto-hMSCs  
STARTED     15     15  
COMPLETED     15     15  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Allo-hMSCs

Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.

Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.

Auto-hMSCs

Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.

Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.

Total Total of all reporting groups

Baseline Measures
    Allo-hMSCs     Auto-hMSCs     Total  
Number of Participants  
[units: participants]
  15     15     30  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     9     5     14  
>=65 years     6     10     16  
Age  
[units: years]
Mean (Standard Deviation)
  62.8  (10.5)     63.7  (9.3)     63.2  (9.7)  
Gender  
[units: participants]
     
Female     2     2     4  
Male     13     13     26  
Region of Enrollment  
[units: participants]
     
United States     15     15     30  



  Outcome Measures
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1.  Primary:   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   [ Time Frame: One month post-catheterization ]

2.  Secondary:   CT Infarct Size From Early Enhanced Defect: - Difference Between the Baseline and 13-month   [ Time Frame: Baseline Month 13 post-catheterization ]

3.  Secondary:   CT Measure of Left Ventricular Ejection Fraction   [ Time Frame: Baseline Month 13 post-catheterization ]

4.  Secondary:   CT Measure of End Diastolic Volume   [ Time Frame: Baseline Month 13 post-catheterization ]

5.  Secondary:   CT Measure of End Systolic Volume   [ Time Frame: Baseline Month 13 post-catheterization ]

6.  Secondary:   CT Measure of Scar Size as % of LV Mass   [ Time Frame: Baseline Month 13 post-catheterization ]

7.  Secondary:   Change in Distance Walked in 6-minutes From Baseline.   [ Time Frame: 12-months ]

8.  Secondary:   Change in Minnesota Living With Heart Failure Total Score   [ Time Frame: 12 months ]

9.  Secondary:   Change in New York Heart Association Class at 12-months   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: amendizabal@emmes.com


Publications of Results:

Responsible Party: Joshua M Hare, University of Miami
ClinicalTrials.gov Identifier: NCT01087996     History of Changes
Other Study ID Numbers: 20090352, R01HL110737, R01HL107110, R01HL084275, P20HL101443, R01HL094849
Study First Received: March 15, 2010
Results First Received: August 30, 2013
Last Updated: May 21, 2015
Health Authority: United States: Food and Drug Administration