Participants will undergo screening tests and then receive a series of injections of a protein that releases stem cells from the bone marrow into the bloodstream. The cells, known as CD34+ stem cells, help spur blood vessel growth and are harvested from the patient during a procedure called apheresis, said Chris Cogle, an assistant professor of medicine at the UFs College of Medicine Program in Stem Cell Biology and Regenerative Medicine.
Participants will then be randomly assigned to receive one of two dosing levels of the cells, or a placebo.
Physicians will use a catheter-based electrical mapping system to find muscle they think is still viable but not functioning, said R. David Anderson, an associate professor of medicine at UF and director of interventional cardiology. The cells are injected into viable sites in the heart, which have poor blood flow, in the cardiac catheterization laboratory at Shands at UF medical center.
Patients will be periodically evaluated by echocardiography and magnetic resonance imaging over the course of a year after the procedure. Although to date study subjects have tolerated this procedure well, potential risks include infection, allergic reactions, bleeding, blood clots and damage to the heart or its vessels.
UF is one of 20 research sites participating in the national study, which is evaluating a total of 150 patients and is sponsored by the Cellular Therapies business unit of Baxter Healthcare Corp. and led by principal investigator Douglas Losordo, M.D., of Northwestern Universitys Feinberg School of Medicine. Baxter makes the cell-sorting equipment used to isolate the cells from the blood.
Pending Food and Drug Administration approval, UF researchers, through the National Heart, Lung and Blood Institute-funded Cardiovascular Cell Therapy Research Network, are gearing up to
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| Contact: Melanie Fridl Ross ufcardiac@aol.com 352-690-7051 University of Florida Source:Eurekalert |