ederal officials moved on Wednesday to stop two clinics from continuing to offer unproven stem cell therapies to patients, the most aggressive action taken in years by regulators against the burgeoning — and what critics call dangerous — field of unapproved, direct-to-consumer stem cell treatments.
In seeking permanent injunctions against the clinics, the Justice Department and the Food and Drug Administration accused the clinics of endangering patient safety and failing to meet manufacturing standards for cell therapies. The action opens a new front in the conflict between authorities and the clinics, which have sprung up by the hundreds around the country and have typically steered clear of regulations by insisting their treatments do not fall under the category of drugs.
“We cannot allow unproven products that exploit the hope of patients and their loved ones,” FDA Commissioner Scott Gottlieb said in a statement.
The two clinics — US Stem Cell, based in Florida, and California Stem Cell Treatment Center — were warned by the FDA in August that they had violated manufacturing procedures and were offering products to patients that had not been evaluated or approved by regulators.
US Stem Cell was the clinic where a 2015 procedure led three women to go legally blind, researchers found. And California Stem Cell Treatment Center was involved in making an experimental cancer treatment from a smallpox vaccine that is not commercially available; federal marshals wound up seizing vials of the vaccine after officials learned the clinic had them.
The FDA on Wednesday said the two clinics had failed to address the agency’s concerns in recent months. The injunctions also target company executives and scientists.
The permanent injunctions would mandate that the clinics halt their stem cell treatments and clean up their manufacturing procedures.
In separate statements, both US Stem Cell and the California clinic and its affiliates said they intended to fight the lawsuits. They argued that the FDA’s efforts interfered in the doctor-patient relationship and that these clinical decisions should be made without meddling from the government.
These types of clinics have popped up around the country, touting that their therapies — which have not gone through standard, regulated clinical trials — can alleviate or even cure maladies ranging from cancer and paralysis to blindness and erectile dysfunction. The clinics say because they take cells from a patient — often from their belly fat — and re-infuse them in the same operation, the cells are “minimally manipulated” and remain separate from what constitutes a “biological drug product.”
But some patients have allegedly been harmed by the treatments, or paid thousands of dollars out of pocket for a treatment that has no evidence of effectiveness. Advocates have been calling on the FDA to be more aggressive against the clinics as they’ve continued to proliferate.
Paul Knoepfler, a stem cell researcher at the University of California, Davis, said the Justice Department and FDA’s action was “unprecedented” and homed in on some of the most influential clinics in the industry. The potential injunction against the California clinic also targeted the affiliated Cell Surgical Network Corporation, which Knoepfler said was a chain that included about 100 clinics.
“It’s possible this one action could cause scores of these firms to stop administering noncompliant stem cells,” Knoepfler said.
The government’s actions Wednesday called to mind what happened with Celltex, a Houston-based company that received an FDA warning letter in 2012. Soon after, it started sending its patients to Mexico for the cell transplants, though it continues to store patients’ cells in Houston. In the Celltex case, however, the Justice Department was not involved, and the FDA did not seek an injunction against the company.
As it as boosted its enforcement actions against clinics offering unproven therapies, the FDA has also tried to promote the development of legitimate stem cell treatments. In November, the agency outlined new regulatory guidelines that included a streamlined approval pathway for promising treatments in clinical trials while more clearly stipulating what standards the clinics already offering treatments need to meet.
But even as the FDA has vowed to take additional action against clinics, some experts have noted that the agency has so far only gone after the alleged worst actors and that hundreds of clinics have continued to operate without oversight.