12 hospitalized in 2018 for infections linked to stem cell shots

Twelve patients were hospitalized last year for infections after getting injections that apparently contained stem cells from umbilical cord blood, according to The New York Times.

The CDC described the cases in a report published Dec. 21. 

The FDA issued a warning to Genetech, the California company that made the blood product the patients received. Seven cases occurred in Texas, four in Florida and one in Arizona, mostly in August and September.

The patients who became ill after receiving the Genetech products had been given injections that supposedly contained stem cells. They injected the stem cell products into their knees, shoulders or spines to treat arthritis or injuries. The patients then contracted infections in their bloodstreams or joints, and all were hospitalized.

On Dec. 20, the FDA said it wrote to 20 clinics that offer unapproved stem cell treatments, warning them that the agency usually regulates such products and encouraging the clinics to contact federal regulators before November 2020, when enforcement will tighten.

"We're going to be going in and inspecting more stem cell operators this year," said FDA Commissioner Scott Gottlieb MD. "We're focused on outfits that may be engaging in unsafe practices and haven't been working with FDA to come into compliance with the laws they're subject to. Unfortunately, there are too many firms that fit this description."

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