The stem cell injections which players are obtaining (here, for the most part illegally.....or in Europe) remain unproven in both efficacy and safety. Anecdotal questionable cause and effect successes (which are grossly over publicized) are more than negated by loads of failures (which are not accompanied by fanfare, and not publicized).
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F.D.A. Cracks Down on ‘Unscrupulous’ Stem Cell Clinics
By
SHEILA KAPLAN and
DENISE GRADY
AUG. 28, 2017
WASHINGTON — The
Food and Drug Administration announced a crackdown on dangerous
stem cell clinics on Monday, while at the same time pledging to ease the path to approval for companies and doctors with legitimate treatments in the growing field.
The agency reported actions against two large stem cell clinics and a biotech company, saying that it was critical to shut down “unscrupulous actors” in regenerative medicine, a broad umbrella that includes stem cell and gene therapies and immunotherapies.
“The F.D.A. will not allow deceitful actors to take advantage of vulnerable patients by purporting to have treatments or cures for serious diseases without any proof that they actually work,” said Dr. Scott Gottlieb, the F.D.A. commissioner.
Stem cells, which can be extracted from bone marrow, blood or fat, can develop into many different types of cells, and are thought to have the potential to repair or replace tissue damaged by disease, injury or aging. But so far, the F.D.A. has approved only a few stem-cell products.
The companies that the F.D.A. cited have been performing
liposuction to remove belly fat from patients, extracting stem cells and then injecting those cells back into the patients to treat various ailments.
On Friday, the agency said, federal marshals seized 500 doses of live Vaccinia virus vaccine for
smallpox belonging to StemImmune Inc., a San Diego firm that develops stem cell-based immunotherapies for
cancer. The raid came after the F.D.A. learned that the vaccine was being used to create an unapproved stem cell product, a combination of excess amounts of vaccine and stem cells derived from body fat, which was then administered to cancer patients with potentially compromised immune systems.
The F.D.A. said patients at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, Calif., received the treatment made with the smallpox vaccine. It also said it had serious concerns about how StemImmune obtained the vaccine for use in an unapproved and potentially dangerous treatment. THE
REST OF THE STORY