FDA issues warning letter to companies on dangerous, unapproved stem cell treatments
Tuesday, January 29, 2019
After 12 people were hospitalized for infections associated with unapproved stem cell treatments, the U.S. Food and Drug Administration (FDA) issued a warning to Genetech, Inc. about the umbilical cord blood-derived cellular products distributed by Liveyon, LLC.
The FDA warned Genetech for processing umbilical cord blood into unapproved human cellular products and for significant deviations from current good manufacturing practice (CGMP) and current good tissue practice (CGTP) requirements.
Umbilical Cord Blood and Stem Cell Treatments
Stem cells have the potential to regenerate any type of cell, which makes cell-based regenerative medicine attractive to marketers touting treatments for a number of illnesses. Hundreds of treatments using unapproved stem cell treatments have appeared across the nation. In fact, there were nearly 600 stem cell clinics selling non-FDA approved offerings in 2016.
While stem cell treatment manufacturers often use umbilical cord blood as the source of transplanted stem cells, umbilical cord blood is difficult to sterilize. There are currently no validated processes for sterilization, so umbilical cord blood cannot be decontaminated. Strict control over the manufacturing of derived products must be implemented to prevent distribution of contaminated products.
Genetech processed umbilical cord blood into unapproved human cellular products; Liveyon, LLC, then distributed the products. Genetech and Liveyon are registered with the FDA, but the Genetech-processed, Liveyon-distributed product is not FDA-approved nor is it lawfully marketed — registration alone is not FDA approval.
Patients Develop Infections after Receiving Bacterially Contaminated Umbilical Cord Blood-Derived Stem Cell Products for Other than Hematopoietic or Immunologic Reconstitution
Twelve patients who had received Genetech products distributed by Liveyon subsequently developed bloodstream infections, joint infections, and epidural abscesses caused by Escherichia coli (E. coli), enterococcus and other bacteria.
The patients had sought treatment for a variety of conditions, including chronic pain, joint or back pain, osteoarthritis or rheumatoid arthritis, and rotator cuff tears. Patients underwent stem cell treatment between February and September 2018. Seven of the cases occurred in Texas, four cases happened in Florida and one case occurred in Arizona.
All of the patients involved were hospitalized; none died. One patient required hospitalization for 58 days, another for 35.
CDC investigators obtained and tested unopened vials from Texas and Florida clinics where the initial patients received the product. The investigators isolated Enterococcus cloacae bacterium from all six of the vials from Texas and isolated E. faecalis from five. All six of the Texas vials were from the same cord-blood donor and processing dates as had been administered to patients who subsequently developed infections.
The four vials from Florida had different processing dates and were from different donors than were the vials from Texas. The CDC investigators isolated E. coli from one of two vials from the same cord-blood donor and processing date. They isolated E.coli and E. faecalis from one of two vials from two unique donors bearing unique processing dates.
The CDC found similar results in vials they tested from other clinics implicated in the investigation. The point of manufacture, rather than the clinics themselves, was the source of the infections.
Morbidity and Mortality Weekly Report (MMWR) described the infections in its report, entitled "Notes from the Field: Bloodstream and Joint Infections in Patients After Receiving Bacterially Contaminated Umbilical Cord Blood-derived Stem Cell Products for Non-hematopoietic Conditions — United States, 2018."
The CDC says that, despite repeated warnings, "many companies, clinics, and clinicians continue to market products from various sources as treatment for orthopedic, neurologic and rheumatologic conditions without FDA approval."
The CDC team notes that using products in this way poses "serious potential risks to patients."
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