Feds raid stem cell clinic amid FDA crackdown

The Food and Drug Administration on Monday announced a crackdown on stem cell clinics offering on “unapproved and potentially dangerous” treatments, including an outfit in California that has been using the smallpox vaccine on ill cancer patients.

U.S. marshals on Friday raided San Diego-based StemImmune Inc. and seized the vaccine, which the FDA said had been combined with stem cells derived from fat to create an unapproved product. The concoction was injected intravenously and directly into patients’ tumors at the California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, the agency said.

FDA Commissioner Scott Gottlieb, in a statement on the case, said the agency “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.”

For years, critics of stem cell clinics performing unproven treatments have called on the FDA to take action against them. One of them, Paul Knoepfler, a biologist at the University of California at Davis, said Monday that the new enforcement actions, coupled with a separate Gottlieb statement on the future of stem cell therapies, “looks like positive news.”

StemImmune responded that it has “fully cooperated with the FDA about the development of its stem-cell based cancer therapy” and that no patients have suffered ill effects from the treatment. Mark Berman, a Beverly Hills plastic surgeon who was a co-founder of California Stem Cell Treatment Centers, called Gottlieb’s comments “libelous,” and added, “We’re not ignoring the FDA and we aren’t renegade doctors.”

In a separate enforcement action, the agency on Monday posted a warning letter issued last week to U.S. Stem Cell of Sunrise, Fla., saying that recent FDA inspections of the clinic found that it was processing body fat into what’s called stromal vascular fraction — stem cells derived from body fat — and administering the product both intravenously and directly into the spinal cord of patients to supposedly treat a variety of serious diseases or conditions.

The FDA said it has not approved any products manufactured by U.S. Stem Cell and that it had documented “significant deviations” from current good manufacturing practices in at least 256 lots of stem cell products by the clinic.