Are you using Stem Cell Products from Genetech?

The U.S. Food and Drug Administration (FDA) recently issued a warning letter to Genetech for marketing stem cell products without FDA approval and for deviating from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including violations that may have led to microbial contamination and caused serious blood infections in patients.

Genetech processes cell-based regenerative products from human umbilical cord blood to treat a variety of orthopedic conditions. According to the FDA, these products, distributed by Liveyon in Yorba Linda, California as ReGen5, ReGen10 and ReGen30, are not intended for homologous use (products that are intended for the same function in the recipient as the donor) and allogeneic (genetically similar) use in a first or second-degree blood relative, and as such, are regulated as both drug and biological products. The FDA explained that to lawfully market these products, an approved biologics license application is needed, and while in the development stage, the products may be used in humans only if an investigational new drug application (IND) is in effect. The FDA found that no such licenses or INDs exist for the Genetech-processed, Liveyon-distributed products.

Moreover, the FDA identified significant deviations by Genetech from CGTP and CGMP requirements. In its warning letter, it noted that “Genetech’s deficient donor eligibility practices, unvalidated manufacturing processes, uncontrolled environment, lack of control of components used in production . . ., and lack of defined areas or a control system to prevent contamination and mix-ups . . . pose a significant risk that your products may be contaminated with microorganisms or have other serious product quality defects.” It also noted that Genetech had no quality control unit from the time manufacturing operations began in mid-2017 through the time of FDA’s inspection in June 2018.  Thus far, the FDA and the Centers for Disease Control and Prevention have received numerous reports of safety issues with Genetech products, including microbial contamination, and are aware of 12 patients who, after receiving Genetech products, became ill due to blood and other infections caused by a number of bacteria, including E. coli.

If you suffered any adverse events related to treatments with the Liveyon products, Genetech products or other stem cell treatments, please contact FBFG to discuss your legal options.