FDA Warns Doctor Over Stem Cell Implants
January 18, 2007 12:36 PM EST
WASHINGTON - 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
Copyright 2007 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
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January 18, 2007 12:36 PM EST
WASHINGTON - 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.
--
On the Net:
Food and Drug Administration warning letter: http://www.fda.gov/cber/compl/stem112206.htm
Copyright 2007 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
© 2007 EarthLink, Inc. All rights reserved.
Members and visitors to the EarthLink Web site agree to abide by our Policies and Agreements.
EarthLink Privacy Policy
Submit your Feedback
http://enews.earthlink.net/channel/news/print?guid=20070118/45aefed0_3ca6_15526200701181456273052
posted by Bill at 4:39 AM
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