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, Florida, 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.”
At the same time, he said, the agency will develop a framework to more clearly describe the “rules of the road” for the field and to allow responsible developers of stem-cell treatments to more easily win FDA approval.
“The FDA must advance an efficient and least burdensome framework as a way to help new products remain compliant with the law through a regulatory structure that does not become a barrier to beneficial new innovation,” he said.
He said, for example, that FDA advance approval for treatments might not be required in cases where cells or tissues are extracted and given back to the same individual or when the cells or tissues do not undergo significant manufacturing and are intended to perform the same basic functions. But when the significant manufacturing occurs or the cells or tissues aren’t intended to perform the same function, greater uncertainty exists and pre-market review is required, he said.
Stem-cell clinics offering unapproved – and unproven – treatments have sprung up by the hundreds across the country over the past several years. Many offer fat-derived injections that supposedly treat everything from hip and knee problems to autism and Alzheimer’s disease.
In the case of the California clinic, the FDA said it had “serious concerns” about how StemImmune obtained the smallpox vaccine, which is not commercially available. The vaccine typically is reserved for people at high risk for smallpox, such as members of the military, it said.
The vaccine is made from a live virus called vaccinia, which is a poxvirus that is similar to smallpox but less harmful. The vaccine can’t cause smallpox, but for people with compromised immune systems – as is the case with many cancer patients – exposure can result in life-threatening medical problems, including myocarditis, which is a swelling of the heart.
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