Publication date: Jun 05, 2019
In a decision expected to send a chill through the booming stem-cell industry, a federal judge ruled in favor of the Food and Drug Administration Monday in a lawsuit against a Florida-based stem cell company whose treatments have blinded at least four patients. Judge Ursula Ungaro agreed the FDA has the authority to regulate a procedure that has become widespread in the burgeoning industry – using patients’ fat to create a stem cell treatment. Ungaro said in her judgment that the FDA is entitled an injunction ordering U. S. Stem Cell, based in Sunrise, to halt the procedure. The judgment represents a major victory for the government, which has increasingly tried to constrain the industry even as it has rapidly expanded in recent years. Scientists, medical associations and health officials have criticized stem cell clinics for selling treatments unproven by science and unapproved by the government for a wide spectrum of unrelated ailments, such as Parkinson’s disease, multiple sclerosis, joint pain and erectile dysfunction. -This decision says the FDA has the authority to define a certain kind of stem cell product as a drug product” requiring FDA approval and compliance with other agency rules, said Paul Knoepfler, a stem cell biologist at the University of California at Davis.
“In 2015 and 2016, at least four patients were blinded after U. S. Stem Cell and clinics associated with the company injected stem cell treatments into their eyes.
After those cases became public, the company stopped injecting patients’ eyes, but continued using its procedure for other conditions. The FDA’s slow initial response to patient injuries 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. Last spring, just three weeks after the government filed suit, an additional patient had a catastrophic reaction after visiting a South Miami clinic affiliated with U. S. Stem Cell.
A 59-year-old woman felt faint and started vomiting two hours after receiving injections for arthritis pain. Her case was described in an “adverse event” report filed with the FDA and obtained by The Washington Post through the Freedom of Information Act. In her judgment Monday, the federal judge said that unless an injunction is issued ordering the company to stop, “there is a reasonable likelihood that Defendants will continue to violate” regulations by continuing the unapproved treatments. With $6. 7 million in revenue last year, U. S. Stem Cell operates three clinics and has trained doctors at 150 others, making it one of the most influential stem cell companies in the nation.
Responding in court, the company called the FDA’s new rules -a power grab” and argued its treatment is a medical procedure that can’t be regulated as a drug. Judge Ungaro noted in her summary judgment Monday that the clinic makes -numerous claims” about the benefits provided by treatment derived from fat cells for an array of illnesses, including Parkinson’s disease, lung disease and diabetes.