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

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

NCT01442129

Run by

Deborah Ascheim

People needed

30

Starts

2012-04-01

Expected to finish

2013-08-01

Last updated by the study team

2015-05-01

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 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;
• 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.

Where it is running

• University of Florida — Gainsville, Florida, United States
• University of Maryland — Baltimore, Maryland, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, 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
• Baylor Research Institute — Dallas, Texas, United States
• Texas Heart Institute — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.