Heart Failure Clinical Trial

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

Summary

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.

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Full Description

Congestive heart failure affects 5 million people in the United States, and over 60,000 are diagnosed with end-stage heart failure. Treatment options for these individuals are extremely limited. Because of a limited supply of donor organs, fewer than 3,000 people receive heart transplants each year. LVADs are battery-operated devices that can act as a temporary solution until a donor heart becomes available. Upon being surgically implanted into a weakened heart, the LVAD mechanically pumps blood from the heart to the rest of the body. There are, however, serious risks associated with LVADs, including infection, blood clots, and stroke. Early removal of the LVAD may be possible by injecting stem cells to regenerate new heart cells and improve heart function. The purpose of this study is to compare the safety and effectiveness of two types of bone marrow cells -- bone marrow mononuclear cells (BMCs) and immunoselected CD34+ hematopoietic stem cells -- in improving heart function in individuals with end-stage heart failure.

This study will enroll individuals undergoing surgery to receive an LVAD. Participants will be randomly assigned to one of following three groups:

Group 1 (n=30): participants will undergo intramyocardial injection of bone marrow mononuclear cells (BMCs) during LVAD implantation

Group 2 (n=30): participants will undergo intramyocardial injection of immunoselected CD34+ hematopoietic stem cells during LVAD implantation

Group 3 (n=15): participants will undergo LVAD implantation

Prior to LVAD implantation, participants in Groups 1 and 2 will have a sample of bone marrow removed. Following LVAD implantation, study visits will occur at Days 45 and 90, and then every 60 days thereafter until participants receive a heart transplant. At each visit, participants will undergo a LVAD wean procedure, during which the mechanical pump of the LVAD will be gradually turned off, and the LVAD will be operated with a hand pump. The length of time that a participant tolerates the wean procedure will be evaluated. Heart size and function, blood flow, and nerve function will also be assessed. Some participants will undergo a 6-minute walk test. At the time of heart transplant surgery, the LVAD will be removed, and heart cell regeneration and heart function will be evaluated.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

1

Study ID:

NCT00383630

Recruitment Status:

Terminated

Sponsor:

Columbia University

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There are 7 Locations for this study

See Locations Near You

Advocate Christ Medical Center
Oak Lawn Illinois, 60453, United States
Jewish Hospital
Louisville Kentucky, 40202, United States
Columbia University
New York New York, 10032, United States
Montefiore Medical Center
New York New York, 10467, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
University of Wisconsin
Madison Wisconsin, 53792, United States
St. Luke's Medical Center
Milwaukee Wisconsin, 53215, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Phase:

Phase 2

Estimated Enrollment:

1

Study ID:

NCT00383630

Recruitment Status:

Terminated

Sponsor:


Columbia University

How clear is this clinincal trial information?

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