Stem Cell Therapy Infections
After suffering for days and months of joint pain, some people decide to try an injection of umbilical cord blood, an unproven stem cell therapy used by orthopedic clinics, chiropractors, and pain doctors. Hoping to get pain relief, patients instead may possibly get serious infections.
These products are not approved by FDA or supported by clinical research because these clinics have less robust oversight of infection control measures, potentially creating risks to patients. The FDA recommends that patients avoid receiving such stem cell therapies outside controlled clinical studies.
As of December 14, Center for Disease Control and Prevention has received 12 reports about stem cell therapy infections from three states: Texas (seven), Florida (four), and Arizona (one).
Infection types included:
- joint infections,
- epidural abscesses,
- and bloodstream infections.
All 12 patients received injections or infusions of Liveyon’s umbilical cord blood-derived stem cell products processed by Genetech, Inc.
On September 22, 2018 the Florida Department of Health announced four cases of infections with Escherichia coli, Enterococcus faecalis, and Proteus mirabilis at an orthopedic clinic.
Liveyon, LLC issued a voluntary nationwide stem cell recall of the Regen Series Product due to possible adverse reactions on October 10, 2018.
The manufacturers of umbilical cord blood must be highly controlled to prevent the distribution of contaminated products because the umbilical cord blood cannot be decontaminated due to no validated processes for sterilization.
These contaminations pose serious risks to patients of stem cell therapies administered for unapproved uses other than hematopoietic or immunologic reconstitution.
* As reported to CDC by health departments.
† Abscess and vertebrae were not cultured; both organisms were isolated from blood, and E. faecalis only was isolated from disc space.
§ No organisms were isolated from skin; both organisms were isolated from blood.