By Pat Anson, PNN Editor
At least a dozen patients undergoing stem cell therapy developed bacterial infections after being injected with unapproved stem cell products, according to the Food and Drug Administration. Most of the patients were being treated for chronic back and joint pain.
All 12 patients were hospitalized, but there were no deaths. Seven of the infections were in Texas, four in Florida and one was in Arizona. CDC investigators found E. coli bacteria in unopened vials at two of the stem cell clinics where the patients were treated.
All of the patients received stem cells derived from umbilical cords that were initially processed by Genetech, a San Diego stem cell manufacturer. The stem cells were recalled in October and the FDA sent a warning letter to Genetech last month saying its donor selection, manufacturing and safety standards were deficient.
“In this case, the company’s failure to put in place appropriate safeguards may have led to serious blood infections in patients,” FDA Commissioner Scott Gottlieb, MD, said in a statement.
This week the FDA also sent letters to 20 other stem cell providers warning them that the agency would step up its enforcement of guidelines for cell-based regenerative medicine. The FDA has long taken a dim view of newer stem cell therapies that have not undergone clinical testing, but said it would use “enforcement discretion” as long as a new treatment does not pose a significant safety risk.
“The letters we’re issuing today to manufacturers, health care providers and clinics around the country are a reminder that there’s a clear line between appropriate development of these products and practices that sidestep important regulatory controls needed to protect patients. Time is running out for firms to come into compliance during our period of enforcement discretion,” Gottlieb said.
Gottlieb has previously warned of “unscrupulous actors” in the stem cell industry that deceive patients with “dangerously dubious products.” Critics have complained the agency's "go slow" approach to regnerative medicine has delayed the development of promising new treatments for autoimmune diseases, cancer, diabetes, neuropathy, back pain and other illnesses.