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.
Clinics offering treatments claim that they are not drugs and therefore do not need F.D.A. approval, but in some cases the agency disagrees. In November 2017, the clinics provided three years for compliance, and said during the period that it would use "discretionary judgment" – give the industry a little playroom, but broke down on clinics as injured patients.
In May, F.D.A. sought permanent orders against two stem cell clinics. En, U.S. Stem Cell Clinic L.L.C. by Sunrise, Fla. had treated three patients who lost sight after stem cells were injected into the eyes. The second, California Stem Cell Treatment Center, with locations in Rancho Mirage and Beverly Hills, had administered a combination of pancreatic vaccines and stem cells to cancer patients.
People who became ill after receiving the Genetech products had been given injections in the knees, shoulders or spines to treat painful conditions such as arthritis or injuries. They entered infections in their bloodstream or joints and all were hospitalized.
A patient spent 58 days in the hospital with a blood infection, a spinal abscess and other spinal problems. Another, with an infected knee, was admitted to hospital for 30 days. The shortest stay was four days; Others lasted 12, 15 or 35 days.
Test of unopened vials in lead products from clinics that gave the shoots, found the same types of microbes that had infected the patients, which included E. coli and other fecal bacteria.
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."  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.