At least a dozen people in three states have developed bacterial infections after getting injections derived from stem cells from umbilical cord blood for ailments like joint and back pain, the Centers for Disease Control and Prevention (CDC) reports.
All 12 patients who became sick were hospitalized – three of whom were admitted for a month or more. To date, none of the patients have died. Seven patients were from Texas, four from Florida, and one in Arizona. The patients were sickened by five different types of bacteria, including E. coli.
“These are not the organisms you want in your blood stream or joint space,” said Dr. Kiran Perkins, CDC medical officer in charge of the investigation.
Health officials found bacteria present in unopened vials manufactured by Genetech Inc., and provided by the California-based distributor, Liveyon LLC. Liveyon was contacted in September 2018 by the Food and Drug Administration (FDA)’s Center for Biologics Evaluation and Research (CBER), which oversees human cells and tissue-based products, about reports of adverse events related to Genetech’s stem cell products. In October 2018, Liveyon recalled its products from Genetech’s ReGen Series.
In November, the FDA issued a warning letter to Genetech that it was marketing the stem cells without agency approval and had deviated from good manufacturing practices that could lead to bacterial contamination.
Stem cells are young cells that can develop into specialized cells like blood cells, bone cells, and brain cells, according to R&D magazine. They are being investigated as potential treatments for various diseases and are approved for a small number of medical procedures. Several clinics across the country, however, are using stem cells for diseases though there is little evidence the practice is safe or effective.