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This clinic's experimental stem cell treatment blinded patients. Years later, the government is stil
Source: Washington Post
This clinic’s experimental stem cell treatment blinded patients. Years later, the government is still trying to stop it.
By Laurie McGinley and William Wan April 3 at 12:00 PM
MIAMI — In the summer of 2015, ophthalmologist Thomas Albini examined a patient who had suddenly lost vision in both eyes. The woman, 78, had macular degeneration and had visited a Miami clinic offering a new treatment: injections of stem cells made from fat in her belly.
Instead of getting better, the woman’s vision deteriorated significantly. Peering into her eyes, Albini said, he saw clumps of blood floating inside.
The next day, a second patient appeared in Albini’s emergency room at the University of Miami complaining of blindness and searing pain after receiving eye injections from the same company, U.S. Stem Cell. Albini reported the cases to the U.S. Food and Drug Administration, urging an investigation.
Now, the FDA is suing to stop the company’s treatments in federal court in Fort Lauderdale, Fla., in one of the government’s most aggressive actions against the burgeoning stem cell business. With the judge expected to rule any day on the government’s charge that U.S. Stem Cell is “openly violating the law and endangering patients,” legal experts say the case could constrain a lucrative industry accused by doctors, lawyers and federal officials of harming dozens of people.
But the FDA’s slow response has permitted U.S. Stem Cell to continue operating four years after those first reports of blindness. Although the company stopped injecting its fat-derived treatments into eyes after the patients sued, it continues to sell the therapy to people with spinal injuries, Parkinson’s disease, multiple sclerosis and other serious chronic conditions.
-snip-
By Laurie McGinley and William Wan April 3 at 12:00 PM
MIAMI — In the summer of 2015, ophthalmologist Thomas Albini examined a patient who had suddenly lost vision in both eyes. The woman, 78, had macular degeneration and had visited a Miami clinic offering a new treatment: injections of stem cells made from fat in her belly.
Instead of getting better, the woman’s vision deteriorated significantly. Peering into her eyes, Albini said, he saw clumps of blood floating inside.
The next day, a second patient appeared in Albini’s emergency room at the University of Miami complaining of blindness and searing pain after receiving eye injections from the same company, U.S. Stem Cell. Albini reported the cases to the U.S. Food and Drug Administration, urging an investigation.
Now, the FDA is suing to stop the company’s treatments in federal court in Fort Lauderdale, Fla., in one of the government’s most aggressive actions against the burgeoning stem cell business. With the judge expected to rule any day on the government’s charge that U.S. Stem Cell is “openly violating the law and endangering patients,” legal experts say the case could constrain a lucrative industry accused by doctors, lawyers and federal officials of harming dozens of people.
But the FDA’s slow response has permitted U.S. Stem Cell to continue operating four years after those first reports of blindness. Although the company stopped injecting its fat-derived treatments into eyes after the patients sued, it continues to sell the therapy to people with spinal injuries, Parkinson’s disease, multiple sclerosis and other serious chronic conditions.
-snip-
Read more: https://www.washingtonpost.com/national/health-science/this-clinics-experimental-stem-cell-treatment-blinded-patients-four-years-later-the-government-is-still-trying-to-shut-it-down/2019/04/03/432d6d04-ff2f-11e8-83c0-b06139e540e5_story.html
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