WASHINGTON(AP)
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 Thursday.
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.
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, Sapse didn't allow an FDA investigator to see
and copy records on his implant patients during a July 6, 2006,
agency inspection of his firm, Stem Cell Pharma Inc., the letter
said in part. The FDA released the letter, dated Nov. 22, 2006, on
Thursday.
Sapse claims on his Web site to have carried out 42 stem cell
implants on patients with MS, Alzheimer's, muscular dystrophy,
cerebral palsy and other disorders, as well as to combat the
effects of aging. Sapse, a Romanian-trained ophthalmologist,
charges $6,000 per procedure. He touts "70 percent
improvements, some very impressive."
A message left for Sapse at his Las Vegas office was not
immediately returned.
The letter demands that 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 like
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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On the Net:
Food and Drug Administration warning letter:
http://www.fda.gov/cber/compl/stem112206.htm
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