NEW YORK (Reuters Health) – Cord-blood-derived products marketed for treatments that the U.S. Food and Drug Administration (FDA) has not approved may be contaminated with bacteria, a new government study shows.
In an investigation of bacterial infections in 20 patients who received products made from umbilical cord blood and marketed as stem-cell treatments, researchers found that not only have these off-label treatments not been proven to provide any benefit, they also may be contaminated with bacteria such as Escherichia coli and Enterobacter cloacae.
The study, by the Centers for Disease Control and Prevention, was published in JAMA Network Open.
“The bottom line is that many stem-cell clinics are offering unproven products that have the potential to be dangerous,” said senior author Dr. Kiran Mayi Perkins of the CDC. “There is good research that is being done on stem-cell therapies, but there are also a lot of clinics that are selling stem-cells for unproven uses.”
“To date, the only stem cell treatments approved by the FDA are products made from a donor’s umbilical cord blood that are used to treat certain cancers and disorders of the blood and immune system,” Dr. Perkins told Reuters Health by email. “If the cells are being used to treat other conditions such as pain, orthopedic conditions, autism, anti-aging, or COVID-19, they are not approved and may not be safe. We urge all patients and healthcare practitioners considering stem-cell therapies to ensure that the stem-cell product is being used for the approved indication or under an Investigational New Drug Application (IND) and is on FDA’s list of approved products.”
Currently, the CDC does not know how common the problem is.
“We do not know how widespread of a problem bacterial contamination of umbilical-cord-blood-stem-cell products could be,” Dr. Perkins said. “Part of the reason is that Infections due to bacterially contaminated stem-cell products may not be reported because there is no requirement to report infections from unapproved products administered outside of a clinical trial. Also, practitioners and clinics that give these unapproved products may also feel a disincentive to report any adverse events, including patient infections, resulting from these treatments if they know that they have administered these products outside of FDA regulations and approvals.”
The CDC began to investigate the issue of contaminated cord-blood products after being notified by state health departments of bacterial infections in seven patients – three in Texas and four in Florida – who had received treatments with these products. The CDC learned that the products had been processed by Genetech, Inc. and distributed by Liveyon, LLC, as the ReGen Series, which was marketed as a treatment for conditions such as pain and arthritis. Liveyon recalled the products on September 28, 2018.
On October 4, 2018, the CDC issued a nationwide call for culture-confirmed infections in patients who had received the ReGen Series products. On December 20, 2018, the FDA issued a warning letter to Genetech that detailed violations of manufacturing requirements, which included insufficient donor testing and screening practices.
As of March 2021, the CDC had culture-confirmed bacterial infections in 20 patients (65% men; median age, 63) following their receipt of cord-blood-derived products for a variety of conditions, including pain, osteoarthritis, rheumatoid arthritis, injury, and quadriplegic limb spasticity. Eight of the cases were in Texas, three in Florida, three in California and one each in Arizona, Kansas , Maine, Colorado and Massachusetts. All but one of the patients required hospitalization.
The most frequently isolated bacteria from the patients were common enteric species, including Escherichia coli (14 patients) and Enterobacter cloacae (seven patients). Among the unopened vials of products examined by the CDC, 65% (22 of 34 vials) were contaminated with at least one of 16 bacterial species.
“This article highlights the importance of using therapies and products in healthcare that are approved by the FDA,” said Dr. Waleed Javaid, director of infection prevention and control at Mount Sinai Downtown, in New York City.
The study underscores the downside of using non-FDA approved treatments, Dr. Javaid, who was not involved in the study, told Reuters Health by email.
“Depending on use, FDA requires certain procedures to ensure sterility of the products,” Dr. Javaid added. “Standards are even more stringent for injectable medications and products. As a rule, any medication that is injected (into veins or joints) needs to sterile. When someone uses non-FDA approved or authorized products, it’s hard to know if it is sterile. In those cases, infections can occur, and that was seen in these cases.”
SOURCE: https://bit.ly/3BrsWY8 JAMA Network Open, online October 7, 2021.
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