A federal judge issued an order Tuesday barring a Florida-based stem-cell company from performing an unapproved procedure that blinded at least four patients.
The order comes three weeks after the judge ruled against the company and in favor of the U.S. Food and Drug Administration, which has ramped up its efforts in the past year to rein in the booming and lucrative stem-cell industry.
It is unclear, however, whether the judge’s order — which is narrowly confined to the one company — will lead other stem-cell clinics to stop the practice. In recent years, the fat-based treatment has become widespread since it relies on a liposuction procedure already routinely performed by many cosmetic clinics that have added stem-cell treatments to their offerings.
Scientists, medical associations and health officials have long criticized stem-cell clinics for selling treatments unproved by science and unapproved by government regulators for a wide spectrum of unrelated ailments, such as Parkinson’s disease, multiple sclerosis, joint pain and erectile dysfunction.
In a statement, the FDA said, “Today’s action by Judge Ungaro is significant and sends a strong message to others manufacturing violative stem cell products. Court decisions like this reaffirm the FDA’s compliance and enforcement efforts in the ongoing fight to protect the public from individuals and clinics who mislead patients with unapproved and potentially harmful medical products.”
U.S. Stem Cell representatives said they are considering their legal options, including whether to appeal. In a statement, the company said, “We’re pleased to see the judge agreed with our position, limiting the injunction only to the SVF [fat-based stem cell] procedure.”
As FDA officials have increasingly cracked down on such companies, many have adapted quickly to attempt to circumvent regulators. Some have changed their marketing language and treatment protocols. Others have shuttered their operations, only to reopen them months later under a different name or location. A few have moved part of their operations overseas.
The judge’s injunction includes directives that appear to discourage such tactics. An independent expert is supposed to “conduct audit inspections” of U.S. Stem Cell’s facilities to make sure the company and people associated with it don’t resume the practice. The company can be fined $15,000 for each day it violates the order.
In recent weeks, U.S. Stem Cell said it has stopped selling the fat-based treatment, but company representatives have also made clear they intend to continue selling variations of the stem-cell treatment — using bone marrow and birth-related tissue — that are also unproven and unapproved but are not barred by the court order.
On its website Tuesday, the company was offering those stem-cell treatments to patients alongside other unproven treatments such as “acoustic wave” and “electromagnetic pulsed wave therapy.”
For many years, the FDA largely ignored the industry even as it grew rapidly. In 2017, the agency told businesses it would give them a three-year grace period during which businesses could work with the FDA to comply with laws and the FDA would only go after clinics offering the riskiest treatments. That grace period ends in 2020.
In Tuesday’s statement, FDA officials acknowledged that very few businesses have contacted them during the grace period to comply with the law. “The pace . . . has been slower than expected,” the agency said. “We know that there are clinics across the country that manufacture or market violative stem cell products to patients. . . . There are many examples of companies deceiving patients with unsubstantiated claims about the potential for stem cell products to prevent, treat or cure serious diseases, and in those cases we are committed to acting to protect patients.”
Agency officials said they are picking up enforcement actions and have sent regulatory letters or warnings to 46 businesses in the past year. But according to experts tracking the industry, there are more than a thousand such businesses now operating.
Laurie McGinley and Julie Tate contributed to this report.