Bone Marrow Cell Transplantation to Improve Heart Function in Individuals With End-Stage Heart Failure

Stopped early · Phase 2

Conditions studied: Heart Failure, Congestive

In brief

Heart failure is a condition in which the heart is unable to pump enough blood to the body's other organs. A heart transplant may be necessary for some individuals with end-stage heart failure. Left ventricular assist devices (LVADs) can assist the heart in pumping blood, and are commonly used until a donor heart becomes available. Bone marrow cells injected into the heart may improve heart function and may lead to earlier LVAD removal. The purpose of this study is to evaluate the safety and effectiveness of injected bone marrow cells in improving heart function in individuals with LVADs who are awaiting heart transplants.

Key facts

Study ID

NCT00383630

Run by

Columbia University

People needed

1

Starts

2007-09-01

Expected to finish

2008-12-01

Last updated by the study team

2019-04-17

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
• Male, postmenopausal female, or female who may become pregnant but is using adequate contraceptive precautions (defined as use of oral contraceptive, intrauterine devices, surgical contraception, or a combination of a condom and a spermicide), with negative pregnancy test
• Admitted to the clinical center at the time of study entry
• Listed with United Network for Organ Sharing (UNOS) for cardiac transplantation
• Clinical indication and accepted candidate for implantation of an FDA approved LVAD as a bridge to transplantation
• Hemoglobin between 9.0 gm/dl and 16.1 gm/dl within 24 hours prior to study entry
• Platelet count between 100,000/ul and 450,000/ul within 24 hours prior to study entry
• White blood cell count between 2,500/ul and upper limit of normal within 24 hours prior to study entry

You may not qualify if…

• Cardiothoracic surgery within 30 days prior to study entry
• Myocardial infarction within 6 months prior to study entry
• Prior cardiac 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 prior to study entry
• Received investigational intervention within 30 days of study entry
• Pregnant or breastfeeding at time of study entry
• HIV positive within 30 days prior to study entry
• Active systemic infection within 48 hours prior to study entry

Where it is running

• Advocate Christ Medical Center — Oak Lawn, Illinois, United States
• Jewish Hospital — Louisville, Kentucky, United States
• Columbia University — New York, New York, United States
• Montefiore Medical Center — New York, New York, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, 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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