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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00383630 |
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.
Condition | Intervention | Phase |
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Heart Failure, Congestive |
Biological: Intramyocardial injection of bone marrow mononuclear cells Biological: Intramyocardial injection of CD34+ selected bone marrow mononuclear cells Device: LVAD alone |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | The Effect of Intramyocardial Injection of Immunoselected Bone Marrow Cells on Myocardial Function in LVAD Bridge to Transplant Patients |
Estimated Enrollment: | 75 |
Study Start Date: | August 2007 |
Estimated Study Completion Date: | September 2010 |
Arms | Assigned Interventions |
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Group 1: Experimental
Intramyocardial injection of bone marrow mononuclaear cells + LVAD
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Biological: Intramyocardial injection of bone marrow mononuclear cells
6mL of bone marrow mononuclear cells will be injected into the myocardium during LVAD implantation.
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Group 2: Experimental
Intramyocardial injection of CD34+ selected bone marrow mononuclear cells + LVAD
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Biological: Intramyocardial injection of CD34+ selected bone marrow mononuclear cells
6mL of CD34+ selected bone marrow mononuclear cells will be injected into the myocardium during LVAD implantation.
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Group 3
LVAD alone
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Device: LVAD alone
LVAD implantation without any intramyocardial injection of bone marrow cells.
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
United States, Illinois | |
Advocate Christ Medical Center | |
Oak Lawn, Illinois, United States, 60453 | |
United States, Kentucky | |
Jewish Hospital | |
Louisville, Kentucky, United States, 40202 | |
United States, New York | |
Columbia University | |
New York City, New York, United States, 10032 | |
Montefiore Medical Center | |
New York City, New York, United States, 10467 | |
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104-4227 | |
United States, Wisconsin | |
St. Luke's Medical Center | |
Milwaukee, Wisconsin, United States, 53215 | |
University of Wisconsin | |
Madison, Wisconsin, United States, 53792-3236 |
Principal Investigator: | Eric Rose, MD | Columbia University Medical Center |
Principal Investigator: | Deborah Ascheim, MD | Columbia University Medical Center |
Principal Investigator: | Siviu Itescu, MD | Columbia University Medical Center |
Responsible Party: | Columbia University Medical Center ( Eric Rose, MD ) |
Study ID Numbers: | 372, P50 HL077096-01 |
Study First Received: | September 29, 2006 |
Last Updated: | August 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00383630 History of Changes |
Health Authority: | United States: Food and Drug Administration |
End Stage Heart Failure LVAD Bone Marrow Transplantation Stem Cell Transplantation |
Heart Failure Heart Diseases |
Heart Failure Heart Diseases Cardiovascular Diseases |