The Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in Patients Undergoing LVAD Implantation
LVAD Therapy: Exploring the Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function
4 other identifiers
interventional
30
1 country
11
Brief Summary
The main purpose of this research is to determine whether injecting mesenchymal precursor cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD) is safe. MPCs are normally present in human bone marrow, and have been shown to increase the development of blood vessels and new heart muscle cells in the heart. In addition, this research is being done to test whether injecting the MPCs into the heart is effective in improving heart function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 heart-failure
Started Apr 2012
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 26, 2011
CompletedFirst Posted
Study publicly available on registry
September 28, 2011
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedResults Posted
Study results publicly available
October 13, 2014
CompletedMay 1, 2015
April 1, 2015
11 months
September 26, 2011
October 7, 2014
April 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Intervention Related Adverse Events
The primary safety endpoint of this study is the incidence of the following potential study-intervention related adverse events within 90 days post intervention (LVAD implantation + intramyocardial injection of study product): infectious myocarditis, myocardial rupture, neoplasm, hypersensitivity reaction, and immune sensitization.
90 days
Secondary Outcomes (1)
Functional Status and Ventricular Function
90 days
Study Arms (2)
MPC Intramyocardial injection
EXPERIMENTALIntramyocardial injections of 25 million Mesenchymal Precursor Cells (MPCs)
Control Solution
SHAM COMPARATORIntramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO
Interventions
Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation
Injection of control solution during the LVAD implantation.
Eligibility Criteria
You may qualify if:
- Signed informed consent, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation;
- Age 18 years or older;
- If the subject or partner is of childbearing potential, he or she must be willing to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening and for a period of at least 16 weeks after procedure;
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening;
- Admitted to the clinical center at the time of randomization;
- Clinical indication and accepted candidate for implantation of an FDA approved implantable, non-pulsatile LVAD as a bridge to transplantation or for destination therapy.
You may not qualify if:
- Planned percutaneous LVAD implantation;
- Anticipated requirement for biventricular mechanical support;
- Cardiothoracic surgery within 30 days prior to randomization;
- Myocardial infarction within 30 days prior to randomization;
- Prior cardiac transplantation, LV reduction surgery, or cardiomyoplasty;
- Acute reversible cause of heart failure (e.g. myocarditis, profound hypothyroidism);
- Stroke within 30 days prior to randomization;
- Platelet count \< 100,000/ul within 24 hours prior to randomization;
- Active systemic infection within 48 hours prior to randomization;
- Presence of \>10% anti-human leukocyte antigen (anti-HLA) antibody titers with known specificity to the MPC donor HLA antigens;
- A known hypersensitivity to dimethyl sulfoxide (DMSO), murine, and/or bovine products;
- History of cancer prior to screening (excluding basal cell carcinoma);
- Acute or chronic infectious disease, including but not limited to human immunodeficiency virus (HIV);
- Received investigational intervention within 30 days prior to randomization;
- Treatment and/or an incompleted follow-up treatment of any investigational cell based therapy within 6 months prior to randomization;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Deborah Ascheimlead
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (11)
University of Florida
Gainsville, Florida, 32610, United States
University of Maryland
Baltimore, Maryland, 21201, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407, United States
Columbia University Medical Center
New York, New York, 10032, United States
Montefiore Einstein Heart Center
The Bronx, New York, 10467, United States
Duke University
Durham, North Carolina, 27710, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Baylor Research Institute
Dallas, Texas, 75230, United States
Texas Heart Institute
Houston, Texas, 77030, United States
Related Publications (1)
Ascheim DD, Gelijns AC, Goldstein D, Moye LA, Smedira N, Lee S, Klodell CT, Szady A, Parides MK, Jeffries NO, Skerrett D, Taylor DA, Rame JE, Milano C, Rogers JG, Lynch J, Dewey T, Eichhorn E, Sun B, Feldman D, Simari R, O'Gara PT, Taddei-Peters WC, Miller MA, Naka Y, Bagiella E, Rose EA, Woo YJ. Mesenchymal precursor cells as adjunctive therapy in recipients of contemporary left ventricular assist devices. Circulation. 2014 Jun 3;129(22):2287-96. doi: 10.1161/CIRCULATIONAHA.113.007412. Epub 2014 Mar 28.
PMID: 24682346DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Deborah D. Ascheim, MD, Associate Professor, Clinical Director of Research, InCHOIR
- Organization
- Mount Sinai
Study Officials
- STUDY CHAIR
Timothy Gardner, MD
Christiana Care Health Services
- STUDY CHAIR
Patrick O'Gara, MD
Brigham and Women's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor, Clinical Director of Research, InCHOIR
Study Record Dates
First Submitted
September 26, 2011
First Posted
September 28, 2011
Study Start
April 1, 2012
Primary Completion
March 1, 2013
Study Completion
August 1, 2013
Last Updated
May 1, 2015
Results First Posted
October 13, 2014
Record last verified: 2015-04