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A Las Vegas doctor has been implanting stem cells harvested from placentas into patients with multiple sclerosis, muscular dystrophy and other diseases in violation of federal law, according to a warning letter released by health officials yesterday.
Dr. Alfred Sapse failed to properly obtain, store, test and process the placentas, as well as screen both the suitability of the donors and the patients given the human tissue, according to the Food and Drug Administration letter. At least 16 patients received the stem cells, the FDA said.
Dr. Sapse also failed to obtain or even seek federal approval to carry out the procedures, done by at least one doctor under his direction, according to the FDA.
Oversight of implants of stem cells and other types of tissue is important to avoid infecting patients with viruses or bacteria.
Furthermore, Dr. Sapse didn't allow an FDA investigator to see and copy records on his implant patients during a July 6 agency inspection of his firm, StemCell Pharma Inc., the letter said. The FDA released the Nov. 22 letter yesterday.
Dr. Sapse says on his Web site that he has carried out 42 stem-cell implants on patients with MS, Alzheimer's disease, muscular dystrophy, cerebral palsy and other disorders, as well as to combat the effects of aging. Dr. Sapse, an ophthalmologist trained in Romania, charges $6,000 per procedure. He touts "70 percent improvements, some very impressive."
A message left for Dr. Sapse at his Las Vegas office was not returned.
The letter demands that Dr. Sapse outline what steps he has taken or will take to correct the violations and prevent them from recurring.
Since the late 1980s, doctors have used blood from the placenta and umbilical cord as a source of adult stem cells. The cells develop to form the major components of blood: infection-fighting white blood cells, oxygen-carrying red blood cells and clot-forming platelets. Because of that ability, they're frequently transplanted, typically in children, to treat blood disorders such as leukemia and lymphoma.
Adult stem cells are not the same as embryonic stem cells, which can form any type of cell in the body.
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