FDA approves stem cells for heart study

[DanCa]

FDA OKs stem cells for heart study

WASHINGTON, Nov. 10 (UPI) -- The Food and Drug Administration has
given the go-ahead for two academic institutions to do a stem-cell
study in heart patients. The FDA has given the nod to Case Western Reserve University School of Medicine and the University Hospitals of Cleveland to conduct a phase I clinical trial to determine whether bone-marrow stem cells can be used to treat chronic ischemia in cardiac patients. The trial is one of three ongoing studies in the United States to use bone-marrow stem cells to treat chronic ischemia.

Stem cells from the patient's bone marrow will be injected in
varying doses into the clogged coronary arteries of patients
suffering from chronic ischemic coronary artery disease to spark the
development of new, healthy blood vessels in patients who are not
candidates for angioplasty, stent placement or coronary artery
bypass grafting, the universities said. The method was developed by Mary Laughlin, a hematologist, and Vincent Pompili, a cardiologist, both of Case Western Reserve, UHC and the National Center for Regenerative Medicine, that focuses on bringing stem-cell research from the laboratory to the bedside, they added.

Dale Adler, vice chair of medicine at Case Western Reserve and UHC,
will lead the study. The Harvard Clinical Research Institute will
help run the trial and will create an independent monitoring board
to ensure patient safety and data integrity, the institutions noted.

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