A report by US CDC was published on Thursday which stated that 12 people across 3 states had developed infections after being treated with stem cell infusions taken from blood of umbilical cord. The blood was incidentally bacteria-infected. The stem cell products received by the patients in Texas, Arizona and Florida hadn’t been approved by the FDA. Processor of the products, Genetech, based in San Diego, was warned by FDA in November about ReGen30, ReGen10 and ReGen5 for allogeneic use. 20 more providers of such regenerative medicine were issued warnings by the agency. Dr. Gottlieb said that firms that threaten health and safety of patients will likely be subjected to further action.
Use of these stem cell products have been approved only for immunologic or hematopoietic reconstitution, meaning for those people who have troubles with blood production. It can either be for bone marrow or blood transplants in people suffering from cancer or immune or blood system disorders. FDA scientists said in March 2017 that although stem cells likely repair damages in the environment that they are injected into, none of it has scientific evidence to back it. Hence, clinical trials are required to prove that stem cell products are safe and that they work. The common people were also warned about the products that might provide ‘miracle treatment’ for any disease or illness.
The infected patients had got the treatment for rheumatoid arthritis pain, rotator cup tear with cyst, osteoarthritis and general pain. After getting the products injected into them, their bloodstreams were infected. Investigation showed that the products were contaminated with E. faecalis and E. coli bacteria. Because there’s no remaining product, the investigation has become tougher. Liveyon, the distributor, recalled all such products nationally and suspended further shipments. Many defects were found in manufacturing facility of Genetech in June. CDC is trying to find out if more patients had gotten the adulterated products and FDA has urged consumers and healthcare professionals to report further treatment-related adverse events, if discovered.