The Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in Patients Undergoing LVAD Implantation

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Deborah Ascheim, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01442129
First received: September 26, 2011
Last updated: October 7, 2014
Last verified: October 2014
Results First Received: October 7, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Heart Failure
Cardiomyopathy
Ventricular Dysfunction
Interventions: Biological: Mesenchymal Precursor Cell Injection
Biological: 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO

  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
The trial was conducted in 11 U.S. centers with a Data and Clinical Coordinating Center (DCC; International Center for Health Outcomes and Innovation Research [InCHOIR], Icahn School of Medicine at Mount Sinai) under an investigational new drug application. Enrollment began in May 2012, and the last patient was enrolled in August 2012.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
MPC Intramyocardial Injection

Intramyocardial injections of 25 million MPCs

Mesenchymal Precursor Cell Injection: Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation

Control Solution

Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO

50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO: Injection of control solution during the LVAD implantation.


Participant Flow:   Overall Study
    MPC Intramyocardial Injection     Control Solution  
STARTED     20     10  
COMPLETED     20 [1]   10  
NOT COMPLETED     0     0  
[1] Treatment withheld from 1 patient randomized before results of screening PRA known



  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.
Patients with end-stage heart failure, either ischemic or non-ischemic etiology, who are being evaluated for LVAD implantation as a bridge-to-transplant (BTT) or destination therapy (DT)

Reporting Groups
  Description
MPC Intramyocardial Injection

Intramyocardial injections of 25 million MPCs

Mesenchymal Precursor Cell Injection: Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation

Control Solution

Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO

50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO: Injection of control solution during the LVAD implantation.

Total Total of all reporting groups

Baseline Measures
    MPC Intramyocardial Injection     Control Solution     Total  
Number of Participants  
[units: participants]
  20     10     30  
Age  
[units: years]
Mean ± Standard Deviation
  55.1  ± 15.4     62.2  ± 7.8     57.4  ± 13.6  
Gender  
[units: participants]
     
Female     3     2     5  
Male     17     8     25  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     1     0     1  
Not Hispanic or Latino     19     10     29  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     6     2     8  
White     14     8     22  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     20     10     30  
Study-Specific Measure  
[units: participants]
     
Ischemic     7     4     11  
Non-Ischemic     13     6     19  
Study-Specific Measure  
[units: participants]
     
Bridge to Transplantation     7     3     10  
Destination Therapy     13     7     20  



  Outcome Measures
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1.  Primary:   Intervention Related Adverse Events   [ Time Frame: 90 days ]

2.  Secondary:   Functional Status and Ventricular Function   [ Time Frame: 90 days ]


  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: Deborah D. Ascheim, MD, Associate Professor, Clinical Director of Research, InCHOIR
Organization: Mount Sinai
phone: 212-659-9567
e-mail: deborah.ascheim@mountsinai.org


No publications provided by Mount Sinai School of Medicine

Publications automatically indexed to this study:

Responsible Party: Deborah Ascheim, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01442129     History of Changes
Other Study ID Numbers: GCO 08-1078-00006, U01HL088942, U01HL088942-04, 711
Study First Received: September 26, 2011
Results First Received: October 7, 2014
Last Updated: October 7, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board