Three women blinded by unapproved stem cell ‘treatment’ at Florida clinic
- By Laurie McGinley, Washington Post
Three women with macular degeneration became permanently blind after undergoing an unproven stem-cell treatment touted as a clinical trial at a South Florida clinic. Medical experts said the episode raises questions about whether the government and doctors are doing enough to protect patients from the dangers of unapproved therapies.
The episode, described Wednesday in an article in the New England Journal of Medicine, represents one of the most egregious examples of patient injury involving a stem-cell clinic. These facilities have sprung up by the hundreds across the country over the past several years. Many offer supposed experimental treatments for ailments ranging from hip problems to autism to ALS.
Of special concern, said Jeffrey Goldberg, professor of ophthalmology at the Stanford University School of Medicine and one of the authors of the report, was the clinic’s ability to list its study on ClinicalTrials.gov, a comprehensive database of clinical trials run by the National Institutes of Health. At least one of the patients — and maybe more — believed that she was taking part in a government-sanctioned study, he said.
Goldberg called the incident a “wake-up call across the spectrum” — for patients, physicians and government regulators. “Surely,” he said, “it’s an opportunity for the FDA to increase patient safety for these unapproved clinical trials.”
Thomas Albini, a University of Miami ophthalmologist and another one of the authors, said that he and his colleagues at the Bascom Palmer Eye Institute had treated two of the patients for severe complications in 2015, shortly after they had undergone the stem-cell procedures at a clinic in Sunrise. The severe complications included detached retinas, hemorrhages and vision loss.
Source: Tampa Bay Times