12 People Hospitalized With Infections From Stem Cell Shots

https://www.nytimes.com/2018/12/20/health/stem-cell-shots-bacteria-fda.html

By Denise Grady
Dec. 20, 2018

Twelve patients became seriously ill after receiving injections that supposedly contained stem cells from umbilical cord blood, according to the Food and Drug Administration, which issued a warning to the California company, Genetech, that made the blood product they were given.

(The company has no connection with Genentech, the biotechnology corporation.)

The F.D.A. said on Thursday that 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.

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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 that they work or are safe.

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In May, the F.D.A. sought permanent injunctions against two stem cell clinics. One, U.S. Stem Cell Clinic L.L.C. of Sunrise, Fla. had treated three patients who lost their sight after stem cells were injected into their eyes.

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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.

One patient spent 58 days in the hospital with a bloodstream infection, a spinal abscess and other spinal problems. Another, with an infected knee, was hospitalized for 30 days. The shortest stay was four days; others lasted 12, 15 or 35 days.

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.

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