The Los Angeles County Health Department (LAC DPH) has identified 2 cases of Enterobacter cloacae bloodstream infections in persons who received non-FDA approved stem cell injections, prompting the issuance of a health advisory to providers.
In October 2018, a nationwide recall of a stem cell product distributed by Liveyon, LLC and processed by Genetech, Inc. was announced. As of December 14, the CDC has received reports of infections in 12 patients from Texas, Florida, and Arizona, all associated with non-FDA approved infusions or injections from this product.
LAC DPH has recently received reports of 2 cases of Enterobacter cloacae bloodstream infections in persons who received non-FDA approved stem cell injections in August 2018 (not from Liveyon).
The CDC investigation of the 12 cases identified Enterobacter, Citrobacter, E. coli, and Enterococcus infections. Sites of infection included knee, bloodstream, lumbosacral abscess, discitis, vertebral osteomyelitis, shoulder, and cellulitis at the injection site.
Patients had received stem cell injections in a variety of clinical settings including orthopedic clinics, an ambulatory surgery center, pain clinics, a chiropractic clinic, and a spine treatment clinic. Among 11 patients for whom conditions prompting product administration were known, all had nonhematopoietic conditions such as pain or orthopedic conditions, for which stem cell treatment is not FDA approved.
LAC DPH reminds providers and patients who are considering the use of stem cell treatments need to be aware of the unapproved therapies that are being marketed and the associated risks, including infection.
In addition, clinicians should inquire about stem cell therapy in patients presenting with bacterial infections and be vigilant for possible infections in patients known to have had unapproved therapies.
Enterobacter is a genus of a common Gram-negative, facultative anaerobic, rod-shaped, non-spore-forming bacteria belonging to the family Enterobacteriaceae. Enterobacter cloacae has taken on clinical significance as an opportunistic and nosocomial pathogen.