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12 People Are Hospitals With Infections From Stem Cell Shots



Twelve patients became seriously ill after receiving injections that contained stem cells from umbilical cord blood, according to the Food and Drug Administration, which warned the California company, Genetech, to make blood products given to them. [19659002] (The company has no connection with Genentech, the biotechnology corporation.)

The FDA said on Thursday it was also written in 20 clinics offering unapproved stem cell treatments, warning them that such products are usually regulated by the agency and encourage clinics to contact federal regulators prior to November 2020, when the enforcement ceases. Names of clinics are not released.

"We are going to go and check more stem cell operators this year," Dr. Scott Gottlieb, the agency's commissioner in an email. "We focus on outfits that may affect unsafe practices and not work with the FDA to achieve compliance with the laws underlying them. Unfortunately, there are so many companies that are suitable for this description."

Hundreds of clinics have appeared throughout the country, offering treatments containing stem cells, to treat various types of diseases, including arthritis, eye disease, pain Parkinson's and lung problems. Treatment is sold as healing or healing properties, but there is no evidence that they work or are safe.

The cases of are described in a report published online Thursday by Centers for Disease Control and Prevention researchers, who wrote, "this investigation demonstrates serious potential risks to patients of stem cell therapists provided for unapproved and unverified "19659002] Genetech did not reach for comment.

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

In September, Texas and Florida health departments investigated some of the infections in a California company called Liveyon, which distributed Genetech products. LiveControl provides.

The F.D.A. It was inspected at Genetech in June, and referred to it as no licensing or new drug applications required for its products. Cleaning and controlling quality is also difficult, the agency said, adding the risk of contamination to germs.

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

In a letter dated November 29, the F.D.A. Genetech president, who referred to it as Edwin N. Pinos, said that its answers were incorrectly the many problems found. The company provided 15 more working days – which ended on Thursday – to take additional steps. And it warns that failure to comply can result in "regulatory action without further notice," including a decree or the seizure of its products.


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