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Feds give researchers ok for safety test of adult stem cells in patients with heart disease

Researchers at Case Western Reserve University School of Medicine and University Hospitals of Cleveland announced that the Food and Drug Administration (FDA) has approved plans to begin a study to evaluate the safety of using adult stem cells from bone marrow to treat chronic ischemia, a serious form of heart disease.

The FDA has approved a Phase I study designed to test the safety of the procedure. It will involve injecting bone marrow stem cells at varying doses into the coronary arteries of patients suffering chronic ischemic coronary artery disease, a condition in which one or more of the primary arteries supplying blood flow to the heart are clogged. The study will include patients who are not candidates for angioplasty, stent placement or coronary artery bypass grafting (CABG).

Dale Adler, M.D., vice chair of medicine at Case and UHC, will lead this study. The Harvard Clinical Research Institute (HCRI) has been contracted to help run the trial and will establish an independent data and safety monitoring board to ensure patient safety and data integrity.

"This is a first step in a long process to determine if this method can someday be used to help patients with this heart condition," said Adler.

The trial is one of three ongoing studies in the United States to use bone marrow stem cells to treat chronic ischemia. The procedure will include harvesting stem cells from a patient's bone marrow, capturing the stem cells, and then infusing the stem cells through a coronary artery so that new blood vessels will grow (neovasculogenesis). The hope is the new blood vessels will replace or supplement those blood vessels that fail to adequately supply oxygenated blood to heart tissue. The method was developed by Mary Laughlin, M.D., a hematologist, and Vincent Pompili, M.D., a cardiologist, both of Case, UHC and the National Center for Regenerative Medicine which has the mission of bringing stem cell research from the laboratory int
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Contact: George Stamatis
George.Stamatis@case.edu
216-368-3635
Case Western Reserve University
9-Nov-2005


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