Unregulated Stem-Cell Therapy Causes Severe Vision Loss for Three Florida Women
A report today in The New England Journal of Medicine (NEJM) describes the cases of three women with age-related macular degeneration (AMD) who lost much of their eyesight after receiving ocular injections of stem cells derived from their own fat tissue. All of the women had good enough eyesight to drive before the procedures. Each paid $5,000 to receive the injections from a private clinic in Sunrise, Florida. The New York Times and other major media outlets have published news stories on the NEJM report.
The administration of the stem cells was performed without oversight from the U.S. Food and Drug Administration (FDA), because, the clinic claims, the cells were the patients’ own — the tissue was extracted from the patients’ bellies. However, the patients said they believed they were participating in government-regulated trials, because the study was listed on www.clinicaltrials.gov, a website maintained by the National Institutes of Health. What’s important for the public to know is that the website listing does not mean that the procedure is approved by the NIH and has undergone FDA review and authorization.
In an accompanying NEJM article, scientists from the FDA say…