In what may be the harshest enforcement order yet against a clinic pitching unproven and potentially harmful stem cell “treatments,” a federal judge has ordered a Florida-based stem cell firm to cease offering the treatments or face thousands of dollars in fines.
Judge Ursula Ungaro of Miami also ordered the firm, Florida-based U.S. Stem Cell, to submit to twice-annual inspections of its facilities by an independent expert for the next two years and annual inspections after that, at its own expense. The firm will have to destroy any stem cell products in its possession, and can’t resume the activities subject to the injunction unless the Food and Drug Administration gives it permission.
Ungaro’s order, which was issued Tuesday, was the result of an FDA lawsuit aimed at shutting down the firm’s stem cell treatment business. The federal lawsuit was filed May 9, 2018.
Overall, this is good news for the stem cell & regenerative medicine field and for patients.
The injunction “sends a strong message to others manufacturing violative stem cell products,” Acting FDA Commissioner Ned Sharpless said.
“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,” Sharpless said. Those providers “are taking advantage of patients, many in vulnerable positions with chronic or terminal diseases, by leveraging the widespread belief in the eventual promise of these products, flouting the statutes and our regulations.”
The injunction is likely to be met with support from academic researchers in the stem cell field. Many are concerned that clinics making unsupported promises for stem cell therapies could undermine the credibility of serious research, which is still in its early stages.
U.S. Stem Cell has been among the most truculent challengers of FDA efforts to regulate clinics peddling purported stem cell treatments for a long roster of medical conditions. Hundreds of such clinics have sprung up across the country in recent years. Typically their procedures involve removing body fat from a patient by liposuction, treating it to extract what it says are stem cells, and reinjecting the extracted fluid into the patient.
Such treatments, which can cost $10,000 or more and generally aren’t covered by health insurance, have not been shown to have any scientific validity.
The treatments can be dangerous. At least three patients suffered vision loss — two of them blinded — after stem cells were injected into their eyeballs at a clinic affiliated with U.S. Stem Cell, according to the FDA.
U.S. Stem Cell claimed that it was exempt from FDA oversight because its treatments involved the use of a patient’s own cells. The FDA rejected the argument, asserting in its lawsuit that under the law the firm’s treatments amounted to the administration of an illegal, unapproved drug. Judge Ungaro agreed, in a ruling issued on June 3. Tuesday’s permanent injunction is a follow-up to that ruling.
Ungaro’s injunction is subject to appeal, but it’s uncertain whether U.S. Stem Cell will pursue it. The publicly traded firm has consistently lost money and its ability to continue as a “going concern” has been questioned by its auditing firm. Its shares were trading at 8 ½-tenths of a cent Wednesday in the over-the-counter market.
The firm recently has been downplaying the treatments that were the subject of the FDA action. Its website currently emphasizes services such as ozone treatments and “nutraceuticals,” some of which are on the fringes of conventional medical practice. U.S. Stem Cell said in a prepared statement that it was “pleased to see the judge agreed with our position limiting the injunction only to” its stem cell procedure.” It said it’s “considering our legal options as to the court’s ruling on the procedure.”
The permanent injunction issued Tuesday by Ungaro could become a template for rigorous FDA oversight over the proliferating clinics offering untested and unvalidated stem cell treatments. According to its terms, U.S. Stem Cell is forbidden to manufacture or distribute its purported stem cell product unless it complies with the law “to FDA’s satisfaction.”
In addition to hiring an independent expert at its own expense to inspect its facilities regularly, the firm will have to submit to inspections on demand by the FDA. The firm will also have to pay the costs of those inspections. Any health-related shortcomings or legal violations uncovered in the inspections will have to be corrected within 15 days. The firm will be subject to penalties of up to $30,000 a day for any uncorrected violations.