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.  (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.
Clinics offering treatments claim that they are not drugs and therefore do not require F.D.A. approval, but in some cases the agency does not agree. In November 2017, it provided clinics for three years to achieve compliance, and said at the time it would use the "enforcement determination" – giving the industry some relief but cracking down on clinics that hurt to patients.
In May, the F.D.A. sought permanent orders against two stem cell clinics. One, the URI Stem Cell Clinic L.L.C. of Sunrise, Fla. had treated three patients who had lost their vision after the stem cells were injected into their eyes. Another, the California Stem Cell Treatment Center, with locations at Rancho Mirage and Beverly Hills, has been providing a combination of smallpox and stem cells vaccinations to cancer patients.
People have become ill after receiving Genetech injections products on their knees, shoulders or spines to cure painful conditions such as bone pain or injuries. They contracted infections in their blood or joints, and were all hospitalized.
A patient spent 58 days in a hospital with blood vessel infection, an abnormal spine and other spinal problems. The other, with the infected knee, was hospitalized for 30 days. The shortest stay is four days; Others take 12, 15 or 35 days.
Examinations of non-open vials of blood blood products taken from clinics that provide shots have found both types of germs infected with patients, who including E. coli and other fecal bacteria.
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.