Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Heart Function in People Receiving an LVAD

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Heart Failure

In brief

Left ventricular assist devices (LVADs) are one treatment option for people with congestive heart failure. This study will evaluate the safety of injecting mesenchymal precursor cells (MPCs) into the heart during LVAD implantation surgery and examine if injecting MPCs into the heart is effective at improving heart function.

Key facts

Study ID

NCT00927784

Run by

Icahn School of Medicine at Mount Sinai

People needed

10

Starts

2009-08-01

Expected to finish

2011-02-01

Last updated by the study team

2019-03-05

Who can join

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

You may qualify if…

• Signed informed consent, release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documents
• Age 18 years or older
• If the participant 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 LVAD implantation
• Female participants of childbearing potential must have a negative serum pregnancy test at screening
• Admitted to the clinical center at the time of study entry
• Listed with the United Network for Organ Sharing (UNOS) for heart transplantation
• Clinical indication and accepted candidate for implantation of an FDA- approved LVAD as a bridge to transplantation

You may not qualify if…

• Cardiothoracic surgery within 30 days of study entry
• Heart attack within 30 days of study entry
• Prior heart transplantation, left ventricular (LV) reduction surgery, or cardiomyoplasty
• Acute reversible cause of heart failure (e.g., myocarditis, profound hypothyroidism)
• Anticipated requirement for biventricular mechanical support
• Stroke within 30 days of study entry
• Received investigational intervention within 30 days of study entry
• Platelet count less than 100,000/uL within 24 hours of study entry
• Active systemic infection within 48 hours of study entry
• Presence of greater than 10% anti-human leukocyte antigen (HLA) antibody titers with known specificity to the MPC donor HLA antigens
• 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)
• Treatment and/or an incompleted follow-up treatment of any investigational therapy within 6 months of study entry
• Active participation in other research therapy for cardiovascular repair/regeneration
• Prior recipient of stem precursor cell therapy for cardiac repair
• Pregnant or breastfeeding at the time of study entry

Where it is running

• Sharp Memorial Hospital — San Diego, California, United States
• Washington Hospital Center — Washington D.C., District of Columbia, United States
• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• Jewish Hospital — Louisville, Kentucky, United States
• University of Michigan — Ann Arbor, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Mount Sinai Medical Center — New York, New York, United States
• Columbia University Medical Center — New York, New York, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Ohio State University Medical Center — Columbus, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Intermountain Medical Center — Salt Lake City, Utah, United States
• Sacred Heart Medical Center — Spokane, Washington, United States
• University of Wisconsin — Madison, Wisconsin, United States
• St. Luke's Medical Center — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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