- The U.S. Food and Drug Administration has issued a warning about unregulated stem cell treatments due to cases of hospitalization after such therapies.
- Cases of severe infections, including E. coli and enterococcus, have been reported post-stem cell therapy which led the patients to hospitalization.
- Much of these stem cell treatments are not FDA-approved or officially marketed, with a particular notice given to products processed by Genetech and distributed by Liveyon.
- Sterilization of umbilical cord blood, often used as the source of transplanted stem cells, is complex and lacks validated procedures which can lead to distribution of contaminated products.
- The FDA is gearing up to strengthen enforcement if companies continue to ignore standard manufacturing guidelines and pose potential health risks to patients.
In the face of a year marked by unfortunate cases of hospitalization brought on by unregulated stem cell treatments, the U.S. Food and Drug Administration has issued an incisive warning about such products. “This cautionary message we’re sending out today to manufacturers, health care providers, and clinics across the country is a stark reminder that there’s a fine line between correct development of these products and practices that skip necessary regulatory checks made for the purpose of protecting patients,” said FDA Commissioner Dr. Scott Gottlieb in his statement.
What are these stem cell treatments?
Commonly known as “cell-based regenerative medicine”, stem cell treatments involve usage of cells capable of maturing into any type of cells. Because of this capability, stem cell treatments have been advertised as a fix-all for various diseases. Despite their controversial status, numerous clinics have been established across America to provide these unstudied treatments. Nevertheless, the FDA has raised concerns over the insufficient monitoring of these clinics. The poor maintenance may expose the expectant patients to extensive damage rather than benefits from these experimental treatments.
Ill-effects of Stem Cell Therapy
In a report disclosed recently, researchers from the U.S. Centers for Disease Control and Prevention revealed that 12 patients, who underwent stem cell therapy, experienced infections so severe that they had to be hospitalized. These patients were seeking the mentioned therapies for varying grievances such as chronic pain, joint or back issues, rheumatoid arthritis or osteoarthritis, rotator cuff tears, among others within the period of February to September 2018. However, severe infections, such as E. coli or enterococcus, immediately invaded the patients’ joints or bloodstreams, served by the stem cell therapy.
Evidence presented by CDC investigator Kiran Perkins’s team indicated that vials used in the implicated clinics contained Enterococcus cloacae bacterium. Moreover, the cause of the infections reported seems to point at the product’s manufacturing stage rather than the clinics administering the therapy.
Involvement of Genetech and Liveyon
The treatments implicated in the warning are linked with processing by Genetech, a San Diego based company, and distributed by Liveyon based in Yorba Linda, Ca. It is important to note that none of the accused stem cell remedies were “FDA-approved or officially marketed”, according to investigators from CDC. A recall of these products was initiated by Liveyon in October.
Researchers from the CDC wish to emphasize the complexity when it comes to sterilizing umbilical cord blood, which is frequently used as the source of transplanted stem cells. No validated procedures currently exist for sterilization after collection, in consequence making the production of derived products highly controlled to evade distribution of contaminated products.
However, in spite of repetitive warnings, many companies, clinics, and clinicians are continuing with their marketing strategies for unapproved orthopedic, neurologic, and rheumatologic treatments obtained from different sources. The researchers have pointed out that this poses as “serious potential risks to patients”.
Final Warning from FDA
The new warning letter is addressed specifically to Genetech and Liveyon. After assessing the conditions at the Genetech’s production site in June, FDA stated that significant deviations were evident from the standard manufacturing guidelines, presenting a high risk that the products could be laden with foreign organisms or other serious product quality defects. This announcement from FDA is the final call before liable companies face more stringent enforcement.
Gottlieb emphasised that the countdown has begun for the companies to fall in line. He added, “We will be intensifying our vigilance in connection with cell-based regenerative medicine as a part of our inclusive plan to foster valuable innovation while safegaurding the patients.”
Additional information on stem cell therapy is available at the U.S. National Center for Biotechnology Information.