12 People Hospitalized With Infections From Stem Cell Shots

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.

“We’re going to be going in and inspecting more stem cell operators this year,” Dr. Scott Gottlieb, the agency’s commissioner, said in an email. “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.”

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.

Clinics offering the treatments claim they are not drugs and therefore do not need F.D.A. approval, but in some cases the agency disagrees. In November 2017, it gave the clinics three years to come into compliance, and said during that period it would use “enforcement discretion”— giving the industry some leeway but cracking down on clinics that harmed patients.

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. The other, the California Stem Cell Treatment Center, with locations in Rancho Mirage and Beverly Hills, had been administering a combination of smallpox vaccine and stem cells to cancer patients.

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.

The cases were described in a report published online on Thursday by researchers at the Centers for Disease Control and Prevention, who wrote, “this investigation highlights the serious potential risks to patients of stem cell therapies administered for unapproved and unproven uses.”

Genetech could not be reached for comment.

Seven cases occurred in Texas, four in Florida and one in Arizona, mostly in August and September. Eleven patients were treated at private clinics specializing in pain or orthopedics, and one — the patient who was hospitalized for 58 days — was treated at an ambulatory surgery center.

In September, health departments in Texas and Florida traced some of the infections to a California company called Liveyon, which distributed Genetech products. Liveyon issued a recall.

The F.D.A. had already inspected Genetech in June, and determined that it did not have the licensing or new drug applications required for its products. Cleaning and quality control were also poor, the agency said, increasing the risk of contamination with germs.

The F.D.A. inspector gave the company a written list of the problems, and the agency said Genetech responded in August.

In a letter dated Nov. 29, the F.D.A. told the president of Genetech, whom it identified as Edwin N. Pinos, that its responses did not correct the many problems that had been found. It gave the company 15 more working days — which ended Thursday — to take further steps. And it warned that failure to comply could result in “regulatory action without further notice,” including an injunction or the seizure of its products.

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