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 stem cell firm to cease offering the treatments. Columnist hiltzikm explains:
also filed by the FDA on May 9, 2018, alleges that Rancho Mirage-based Cell Surgical Network and affiliated clinics are breaking the law by offering customers treatments using stem cells, including those purportedly extracted from their fat. That case, in which the agency is seeking a permanent injunction, is pending in federal court in Riverside.
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.
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.
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