FDA Warns Companies on Unsafe, Unapproved Stem Cell Treatments

After infections tied to unapproved stem cell treatments sent 12 people to the hospital this past year, the U.S. Food and Drug Administration has issued a stern warning about the products.

At issue are stem cell treatments -- so-called "cell-based regenerative medicine." These treatments have long been marketed as a cure-all for a range of illnesses. Hundreds of clinics touting the unapproved treatments have sprung up across the United States. However, shoddy oversight may have led some hopeful patients to be seriously harmed, not helped, by these therapies, the FDA said.

In a report published in the Dec. 20 issue of the U.S. Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report, researchers say 12 stem cell therapy patients developed infections so severe they required hospitalization, although none died. Seven of the cases occurred in Texas, four in Florida, and one in Arizona, according to a team led by CDC investigator Kiran Perkins, M.D. Between February and September of 2018, these patients sought the treatments for a variety of complaints, including chronic pain, joint or back pain, rheumatoid arthritis or osteoarthritis, and rotator cuff tears. But potentially deadly infections, such as Escherichia coli or Enterococcus cloacae, quickly set in within the patients' joints or bloodstreams. One patient required hospitalization for 58 days, while another was hospitalized for 35 days.

The CDC investigators say that in one Texas clinic implicated in cases there, the Enterococcus cloacae bacterium was found in all six vials containing the stem cell product used. Similar results were found in vials tested at other implicated clinics. However, the source of the infections cited in the new report seemed to be the point of manufacture, not the clinics themselves. The products covered by the new warning were processed by Genetech (not to be confused with the well-known biotechnology company Genentech) and were distributed by Yorba Linda, California-based Liveyon. None of the stem cell products were "FDA-approved or lawfully marketed," the CDC researchers said. Liveyon issued a recall of the implicated products in October.

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