The FDA has warned the California company that manufactured the stem cell shots, Genentech. The FDA also contacted 20 clinics that sell unapproved stem cell treatments.
Tests of unopened vials of the umbilical cord blood stem cell shots found the same types of microbes that infected the patients, including E. coli and fecal bacteria.
FDA Commissioner Scott Gottlieb, MD said the agency is going to be inspecting more stem cell operators.
“We’re focused on outfits that may be engaging in unsafe practices and haven’t been working with FDA to come into compliance with the laws they’re subject to. Unfortunately, there are too many firms that fit this description.”
Stem cell clinics provide treatments that are advertised as a “cure-all” for conditions including arthritis, joint pain, eye disorders, Parkinson disease, and more, with little evidence they are safe or effective.
The outbreak of bacterial infections include Texas (7), Florida (4), and Arizona (1), with infections mostly occurring in August and September 2018. Eleven of the patients were treated at private clinics that specialize in pain or orthopedics.
In September, health officials in Texas and Florida traced some of the infections to a company in California called Liveyon, which distributes Genentech products. Liveyon announced a recall in October 2018.