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12 people hospitalized with stem cell infections




Twelve patients became seriously ill after having received injections that apparently contained stem cells from umbilical cord blood, according to the Food and Drug Administration, which issued a warning to California company Genetech, who made the blood product they were given. 19659002] (The company has no connection with Genentech, the biotechnology company.)

The FDA said Thursday that it had also written to 20 clinics offering unauthorized stem cell treatments and a warning that such products are generally regulated by the agency and encourage the clinics to contact federal regulators before November 2020, when enforcement will tighten. The name of the clinics is not published.

"We will check and inspect more stem cell operators this year," said Dr. Scott Gottlieb, the agency's commissioner, in an email. "We are focused on outfits that may be engaged in unsafe routines and have not worked with the FDA to comply with the laws they are subject to. Unfortunately, there are too many companies that fit this description."

Hundreds of clinics have spread get around the country, offering treatments that allegedly contain stem cells to treat a large number of ailments including arthritis, eye disease, Parkinson's disease and lung problems. The treatments are marketed as medicinal or healing properties, but there is no evidence that they work or are safe.

cases were described in a report published on the web Thursday by researchers at the Disease Control and Prevention Centers, which wrote: "This study highlights the serious potential risks for patients of stem cell therapies administered for unauthorized and unproven use." [19659002] Genetech could not be reached for comment.

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

The health departments in Texas and Florida are traced in September by some of the infections of a California company called Liveyon, which distributed Genetech products. Liveyon released a recall.

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

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

In a letter dated 29 November, F.D.A. the president told Genetech, as it identified as Edwin N. Pinos, that its response did not correct the many problems that had been found. It gave the company 15 more business days – which ended Thursday – to take further steps. And it was announced that non-compliance could lead to "regulatory actions without notice", including an injunction or seizure of its products.



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