US cracks down on dodgy, or even fake, stem cell clinics

New York

THE Food and Drug Administration (FDA) announced a crackdown on dangerous stem cell clinics 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, which includes stem cell and gene therapies and immunotherapies.

"The FDA 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 FDA 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 ageing. But so far, the FDA has approved only a few stem cell products.

The companies that the FDA 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 FDA learnt 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 FDA said patients at the California Stem Cell Treatment Centres in Rancho Mirage and Beverly Hills, California, 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.

StemImmune obtained at least some of the vaccine from the Centres for Disease Control and Prevention, according to Thomas Skinner, a CDC spokesman.

A statement from StemImmune said the company had lawfully obtained the drug.

The FDA also issued a warning letter to US Stem Cell, a private clinic in Sunrise, Florida. The company was the subject of a March report in The New England Journal of Medicine, describing how one woman went blind and two others suffered severe, permanent eye damage after being given shots of stem cells, extracted from fat, into their eyes.

The warning letter accused the company of impairing the FDA's ability to conduct its inspection. NYTIMES