(The company has no connection with Genentech, the biotechnology corporation.)
The FDA said Thursday it had also written to 20 clinics that offer unapproved stem cell treatments, warning them that such products are generally regulated by the agency and encouraging the clinics to contact federal regulators before November 2020, when enforcement will tighten. The names of the clinics have not been released.
Hundreds of clinics have sprung up around the country, offering treatments supposedly containing stem cells, to treat a wide variety of ailments, including arthritis, eye disorders, Parkinson’s disease and lung problems. The treatments are marketed as having curative or healing properties, but there is no proof they work or are safe.
Clinics offering the treatments claim they are not drugs and therefore do not need FDA approval, but in some cases the agency disagrees. In November 2017, it gave the clinics three years to come into compliance, and said during that period it would use “enforcement discretion"— giving the industry some leeway but cracking down on clinics that harmed patients.
In May, the FDA sought permanent injunctions against two stem cell clinics. U.S. Stem Cell Clinic LLC of Sunrise, Florida, had treated three patients who lost their sight after stem cells were injected into their eyes. The California Stem Cell Treatment Center, with locations in Rancho Mirage and Beverly Hills, had been administering a combination of smallpox vaccine and stem cells to cancer patients.
The people who became ill after receiving the Genetech products had been given injections into their knees, shoulders or spines to treat painful conditions like arthritis or injuries. They contracted infections in their bloodstreams or joints, and all were hospitalized.
Tests of unopened vials of the cord-blood products taken from clinics giving the shots found the same types of microbes that had infected the patients, which included E. coli and other fecal bacteria.
The cases were described in a report published online Thursday by researchers at the Centers for Disease Control and Prevention, who wrote, “this investigation highlights the serious potential risks to patients of stem cell therapies administered for unapproved and unproven uses.”
Genetech could not be reached for comment.
This article originally appeared in The New York Times.