FDA cracks down on stem-cell clinics, including one using smallpox vaccine in cancer patients
By Laurie McGinley
The Food and Drug Administration on Monday announced a crackdown on stem-cell clinics offering unproven and potentially dangerous treatments, including an operation in California that the agency said was using the smallpox vaccine on seriously ill cancer patients.
U.S. marshals on Friday raided San Diego-based StemImmune and seized the vaccine, which the FDA said had been combined with fat-derived stem cells 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 StemImmune, 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.”
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 using stem cells derived from fat to purportedly treat illnesses including Parkinson’s disease, ALS and heart disease. The agency said it hasn’t approved any of the clinic products for any use.
The clinic in March was the subject of a New England Journal of Medicine article that said that three women with age-related macular degeneration were blinded or had their vision badly impaired after undergoing procedures at the clinic. Stem cells were injected into their eyeballs.
Gottlieb, in a separate policy statement about stem cell therapies, said that the emerging field of cell-based and so-called regenerative medicine holds “significant promise for transformative and potentially curative treatments” for serious illnesses but that “a small number of unscrupulous actors” is putting the field at risk. He said he is launching a new working group at the FDA “to pursue unscrupulous clinics through whatever legally enforceable means are necessary to protect the public health.”…
Source: Washington Post