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The only FDA-approved stem cell products come from umbilical cord blood, and they're approved for just one use: rebuilding the blood-forming and immune systems (hematopoietic and immunologic reconstitution). In 2018, unapproved cord blood products given for other purposes caused a cluster of serious bacterial infections.
How it came to light
| Date (2018) | |
|---|---|
| Sept. 17 | Texas health officials learn of bloodstream infections (Enterobacter cloacae, Citrobacter freundii) in three patients injected or infused at an outpatient clinic on Sept. 12; their E. cloacae isolates match, pointing to a common source |
| Sept. 22 | Florida learns of joint infections (E. coli, Enterococcus faecalis, Proteus mirabilis) in four patients injected at an orthopedic clinic between Feb. 15 and Aug. 30; unopened products from the clinic are found contaminated |
| Sept. 28 | distributor Liveyon, LLC, recalls the products, processed by Genetech, Inc., and stops buying them |
| Oct. 4 | CDC asks for reports nationwide |
The patients
By December 14, CDC had reports of 12 patients in three states — Texas (7), Florida (4) and Arizona (1) — all given Liveyon's product before the recall, at settings including orthopedic, pain and chiropractic clinics and an ambulatory surgery center. The injections were for pain and joint problems such as degenerative joint disease and osteoarthritis — none for the approved use. Infections included bloodstream and joint infections and epidural abscesses. All 12 were hospitalized — one for 58 days — and none died.
What the vials showed
CDC tested unopened vials from the first Texas and Florida clinics:
- All six Texas vials — same donor and processing date as those given to the sick patients — grew E. cloacae, and five also grew C. freundii.
- Among four Florida vials, from different donors and dates, two grew E. coli, one of them also E. faecalis.
The contamination appears to have happened before distribution. Cord blood can't be sterilized after collection — there's no validated method — so making these products demands tight controls.
The wider warning
The product was not FDA-approved or lawfully marketed. Both companies were registered with FDA, but registration is not approval and doesn't show compliance with the law.
The safety and effectiveness of stem cells for anything beyond their approved use haven't been established, yet many companies and clinics market them for orthopedic, neurologic and rheumatologic conditions. They often operate in outpatient settings with weaker oversight of infection control and injection safety. FDA advises patients to avoid such products outside controlled clinical studies under an investigational new drug application.
Report any adverse events from unapproved stem cell treatments to FDA's MedWatch program.
Sources
Based on Kiran M. Perkins, Samantha Spoto, Danielle A. Rankin and colleagues (CDC, Florida Department of Health and FDA), "Notes from the Field: Infections After Receipt of Bacterially Contaminated Umbilical Cord Blood–Derived Stem Cell Products for Other Than Hematopoietic or Immunologic Reconstitution — United States, 2018," MMWR, Centers for Disease Control and Prevention; a work of the United States government in the public domain.
Licens: CC0 1.0 (offentligt eje) · Bearbejdet efter www.cdc.gov
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