The FDA says it took action against one clinic in Florida and one in California last week
Commissioner said the agency would take additional actions in the coming months
The US Food and Drug Administration indicated Monday that it will be increasing oversight and enforcement to prevent the use of potentially dangerous and unproven stem cell treatments.
On its website, the agency posted a warning letter that it sent last week to U.S. Stem Cell Clinic of Sunrise, Florida, accusing the clinic of selling unapproved and nonsterile stem cell treatments and injecting them intravenously or directly into patients’ spines.
The FDA also said Monday that it sent US marshals last week to StemImmune Inc. of San Diego to seize five vials of a live virus vaccine reserved for people at high risk of smallpox. After being mixed with stem cells, the unapproved concoction was injected directly into the tumors of cancer patients at California Stem Cell Treatment Centers in Rancho Mirage and Beverly Hills, the FDA said.
Chief Science Officer Kristin Comella of U.S. Stem Cell wrote in a statement that the company is “not violating the law as it is currently written.”
“It is inappropriate and harmful to state that our clinic is not sterile as we are completely compliant with the regulations for surgical procedures,” she wrote. “The strict regulations mentioned in the warning letter required to manufacture drugs are not applied to clinics or hospitals.”