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.
George Stamatis | EurekAlert!
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