Public health experts have been warning us about clinics offering unapproved and untested stem cell treatments for some time now. But a recent report from the Centers of Disease Control and Prevention (CDC) underscores the health risks these procedures can have. An outbreak linked to stem cell injections contaminated with bacteria sickened at least 12 people this year, the report found.
According to the report, the first whiff of the outbreak came in September, when Texas health officials learned of three cases in which people got serious infections after receiving a stem cell treatment at an outpatient clinic. That same month, Florida officials reported another four cases from between February and August. Since then, there have been three other cases reported in Texas, along with one in Arizona. Though all of the patients were hospitalized with infections, some for over a month, fortunately no one died.
The infections were all linked to stem cell products distributed by a California company called Liveyon; Liveyon in turn had obtained its products (processed from umbilical cords donated after birth) from the biotech company Genetech. Supplies of unused stem cell products at the affected clinics were found to be contaminated with bacteria including Escherichia coli and Proteus mirabilis, which commonly infect wounds, and similar strains of these bacteria were also found in the sickened patients. So it’s likely the contamination happened before the products ended up at the clinics.
Stem cells are immature cells that can transform into other kinds of cells. They interest scientists who are eager to use them to regrow or heal damaged parts of the body. Currently, though, stem cell products processed from umbilical cords are only approved to help restore a person’s immune system or supply of stem cells, usually following treatments like chemotherapy or bone marrow transplants. But nearly all of the patients who were sickened had received the stem cells for unapproved conditions like nerve pain or joint problems.
In late September, Liveyon issued a voluntary recall of its Genetech-sourced products and announced it would discontinue its use of the products. But that seemingly hasn’t been enough for the Food and Drug Administration. Last week, the agency once again issued a warning to Genetech over the unapproved use and marketing of these products, as well as its lack of good safety practices. It also sent letters to other clinics and companies selling off-label stem cell treatments, reminding them of the regulations surrounding stem cell treatments.
As things stand, companies technically have until November 2020 to file their stem cell products for approval with the FDA. Until then, the agency has promised to be lenient in how it regulates companies and clinics currently selling off-label stem cell treatments, depending on how these products are used and the risks they might pose to consumers. But Gottlieb warned that the agency would aggressively go after companies and clinics that are getting people sick.
“The letters we’re issuing today to manufacturers, health care providers and clinics around the country are a reminder that there’s a clear line between appropriate development of these products and practices that sidestep important regulatory controls needed to protect patients. Time is running out for firms to come into compliance during our period of enforcement discretion,” he said in a statement.
Scientists and researchers, meanwhile, have criticized the FDA for its tolerance of these clinics. Several studies have shown that clinics in both the U.S. and elsewhere are frequently claiming to treat everything from Alzheimer’s disease to HIV with the help of stem cells—claims that are not yet supported by strong evidence.