Las Vegas doctor, Dr. Alfred Sapse 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.
Oversight of implants of stem cells and other types of tissue is important to avoid infecting patients with viruses or bacteria.

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.

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.

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.

Food and Drug Administration warning letter:

Link


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