Three women with eye disease were left nearly or totally blind by a vision treatment at a stem cell clinic, in what the doctors called a dramatic illustration of how risky such clinics can be.
“These women had fairly functional vision prior to the procedure ... and were blinded by the next day,” said the ophthalmologist Dr Thomas Albini of University of Miami, whose team examined the three women after their treatment at a clinic in Florida.
He said that, one woman is totally blind and the other two women are legally blind, and it was very unlikely their vision would improve, after their treatment with a method that had not been proven effective or tested for safety on the people, he told to the New England Journal of Medicine.
THE Scientists have long studied the use of stem cells, including those taken from a patient’s own body, for treating vision problems and also a variety of other diseases. But they and regulators have also issued warnings about clinics which offer unproven stem cell therapies. The new report said that the three women, aged in 70s and 80s, paid $5,000 to be treated in the year 2015 for age-related macular degeneration.
Albini said that, at least two of the women had gone to the clinic because it listed a macular degeneration study on the federal database. The clinic later withdrew the listing before recruiting any patients to participate.
Each woman was injected in both the eyes with a cell preparation derived from her own fat tissue. He said that all the women suffered detached retinas.
Andrew B Yaffa, an attorney in the Coral Gables, Florida, who represented two of the women in lawsuits about the treatment, said that both legal cases had been resolved but provided no details.
According to the company’s website, the clinic is operated by the US Stem Cell, Inc. It offers stem cell treatments for a variety of diseases and also injuries. In a statement on Tuesday, the company, based in the Sunrise, said that it did not currently treat eye patients. The company said that it could not comment on specific cases, but the company said that its clinics “have successfully conducted more than 7,000 stem cell procedures with less than 0.01% adverse reactions reported”.
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In an editorial accompanying the journal report, the stem cell expert Dr George Daley, dean of the Harvard Medical School, called the clinic’s treatment as careless.
The federal database where Florida clinic listed a study is called the ClinicalTrials.gov. Albini said that a listing there was no guarantee that a study was legitimate.
Many stem cell clinics argue that they are not subject to regulation by the US Food and Drug Administration (FDA), which oversees the most research in people. So Albini said that study participants should get written documentation that a study has been registered with the FDA.
The ClinicalTrials.gov is overseen by National Institutes of Health (NIH). In a statement, the NIH said that the information on the website was provided by the study sponsor or principal researcher, and that posting on the site did not necessarily reflect endorsement by the NIH. NIH also said that, the site “does not independently verify the scientific validity or relevance of the trial itself beyond a limited quality control review.”
The site urges the patients to talk to their doctors about whether to join a study, the agency said.
Mrudula Duddempudi.
