This year, 12 people have been hospitalized with bacterial infections after being treated with stem cell products derived from umbilical cord blood and manufactured by Genetech, a biotech firm in San Diego and distributed by Liveyon in Irvine, California, according to a Centers for Disease Control and Prevention report out today (December 21).
In a November 29 warning letter, the Food and Drug Administration (FDA) listed the many problems it had found during an inspection of Genetech this June and gave the company 15 business days to respond with what it had done to correct the deficiencies. Then yesterday, the FDA issued a press release detailing its concerns about Genetech products, calling them “dangerous,” and noting that “deviations not corrected by companies and owners could lead to enforcement action such as seizure, injunction or prosecution.”
“The FDA is committed to advancing the field of cell-based regenerative medicine. We’re implementing new policies to make it more efficient to safely develop these promising new technologies,” FDA Commissioner Scott Gottlieb says in the press release. “At the same time, we’re also focusing more resources on enforcement when we see companies skirt safety measures and put patients at risk. In this case, the company’s failure to put in place appropriate safeguards may have led to serious blood infections in patients.”
In the release, the FDA says it is sending letters to other stem cell companies to remind them of their responsibilities to comply with federal regulations.
“We’re focused on outfits that may be engaging in unsafe practices and haven’t been working with F.D.A. to come into compliance with the laws they’re subject to. Unfortunately, there are too many firms that fit this description,” Gottlieb tells The New York Times.
There are hundreds of stem cell clinics around the country offering services to treat all manner of ailments, though, as Times notes, there’s no proof that they are safe or effective.
Genetech represents one more case of the federal government taking action against these clinics when it finds their practices are unsafe. In August 2017, the FDA raided a California clinic that was injecting stem cells mixed with smallpox vaccine into patients’ blood and tumors. The agency also sent a warning letter to a Florida clinic that had cleanliness issues and was operating without the necessary license. This October, the Federal Trade Commission took action against two companies engaged in false advertising about the effectiveness of their stem cell treatments.
In September, after patients in Florida and Texas wound up in the hospital with bacterial infections of the blood and joints, unopened vials of Liveyon stem cell products were found to be contaminated with E. coli and E. faecalis—both fecal bacteria. On September 8, Liveyon issued a recall of the products and stopped purchasing from Genetech, and on October 4, the CDC issued a call for reports of similar infections in people who had used Liveyon’s products. As of December 14, the CDC had received reports of infections in 12 patients from Florida, Texas, and Arizona.
According to the CDC release, the only FDA-approved stem cell product is umbilical cord blood used for hematopoietic and immunologic reconstitution. Genetech’s products, used for orthopedic purposes, would require a biologics license or investigational drug application in order to be lawfully marketed, according to the FDA release, neither of which Genetech has supplied.
In November 2017, the FDA published a regulatory framework for stem cell products. Until November 2020, it says, the government will use “discretionary enforcement” of the framework, essentially cracking down when safety concerns arise, as they have with Genetech.