F.D.A. Cracks Down on ‘Unscrupulous’ Stem Cell Clinics

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.

...https://www.nytimes.com/2017/08/28/health/fda-stem-cell.html?smid=tw-nytimes&smtyp=cur&_r=0