FDA Approves Stem Cell Trial for Chronic Ischemia
Food and Drug Administration (FDA) has approved Phase 1 study to evaluate the safety of using adult stem cells from bone marrow to treat chronic ischemia, a serious form of heart disease.
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 trial is one of three ongoing studies in the United States to use bone marrow stem cells to treat chronic ischemia.
“Traditionally, physicians have been able to prevent heart attack or alleviate its after-effects, but they have not figured out how to initiate the sort of blood vessel repair that remains a key to survival,” says Dr. Laughlin. “Now there is a promise of achieving that repair by infusing highly selected marrow stem cells.”
The Phase I study is being conducted at University Hospitals of Cleveland with support from the National Institutes of Health, Case Western Reserve University, and Cleveland-based Arteriocyte.
