FDA cracks down on stem-cell clinics, including one using smallpox vaccine in cancer patients – Washington Post

 In Health

An employee at a clinic in California prepares a syringe used to inject stem cells into a patient. (Patrick T. Fallon for The Washington Post)

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 seriously 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.”  He added, “I feel encouraged that this is a big step in the right direction.”

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, including Parkinson’s disease, ALS, and heart and lung disease.

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. The agency also said the clinic tried to impede the FDA’s investigation by refusing to allow entry except by appointment and by denying FDA investigators access to employees.

The clinic in March was the subject of a New England Journal of Medicine article that said three women with age-related macular degeneration were blinded or had their vision badly impaired after stem cells were injected into their eyeballs.

In a statement, U.S. Stem Cell said that “the safety and health of our patients are our number one priority and the strict standards that we have in place follow the laws” of the FDA. It said that it has never had a “breach of sterility and our facility has demonstrated sterile surgical techniques as required by the state medical boards.”

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 many cases, the therapies involve liposuction — extracting stem cells from patients and processing them with enzymes and other materials — and then re-injecting them at different places in the body. Despite the proliferation of clinics, most stem-cell research remains at an early stage, and the FDA has approved only a few therapies, mostly for blood disorders.

Gottlieb, in the 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.”

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