Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients

Completed · Phase 2

Conditions studied: Heart Failure, Cardiomyopathy, Ventricular Dysfunction

In brief

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.

Key facts

Study ID

NCT02362646

Run by

Annetine Gelijns

People needed

159

Starts

2015-07-01

Expected to finish

2019-08-23

Last updated by the study team

2019-11-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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 (US sites only) or Health Canada-approved (Canadian sites only) 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
• Concomitant arrhythmia ablation at time of LVAD implantation
• - Planned aortic valve intervention for aortic insufficiency at the time of LVAD implantation
• Cardiothoracic surgery within 30 days prior to randomization
• Spontaneous myocardial infarction related to ischemia due to a primary coronary event such as unstable plaque rupture, erosion or dissection 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
• Acute infectious process: acute bacterial, fungal, or viral disease OR acute exacerbation of chronic infectious disease such as hepatitis
• Presence of >10% anti-HLA antibody titers with known specificity to MPC donor HLA antigens
• A known hypersensitivity to dimethyl sulfoxide (DMSO), murine, and/or bovine products
• History of a known active malignancy within the past 3 years except for localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that has been definitively treated
• Presence of human immunodeficiency virus (HIV)
• Received investigational intervention within 30 days prior to randomization
• Treatment and/or an incomplete follow-up treatment of any investigational cell based therapy within 6 months prior to randomization
• Active participation in other research therapy for cardiovascular repair/regeneration
• Prior recipient of stem precursor cell therapy for cardiac repair
• Pregnant or breastfeeding at time of randomization.
• History of known or suspected hypercoagulable state in the opinion of the investigator

Where it is running

• University of Southern California — Los Angeles, California, United States
• Stanford University School of Medicine — Stanford, California, United States
• University of Maryland — Baltimore, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Columbia University Medical Center — New York, New York, United States
• Montefiore Einstein Heart Center — The Bronx, New York, United States
• Duke University — Durham, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Baylor Research Institute — Plano, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• University of Virginia Health Systems — Charlottesville, Virginia, United States
• University of Wisconsin School of Medicine and Public Health — Madison, Wisconsin, United States
• University of Alberta Hospital — Edmonton, Alberta, Canada
• Toronto General Hospital — Toronto, Ontario, Canada
• Institut Universitaire de Cardiologie de Quebec (Hopital Laval) — Québec, Quebec, Canada

Full record on ClinicalTrials.gov

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