FDA Wins Federal Case Against Stem Cell Clinic, But How Impactful Will the Ruling Be?

On June 3, a federal judge ruled in favor of the Food and Drug Administration (FDA) in a lawsuit against the Florida-based company U.S. Stem Cell, which offers unapproved, controversial stem cell treatments for various health conditions. Starting in 2015, U.S. Stem Cell’s stem cell treatments blinded at least four patients who received fat-derived stem cell injections into their eyes.

The federal judge agreed that the FDA has the authority to regulate fat-derived stem cell treatments, which are becoming increasingly popular across the nation. Despite the growing number of available treatments, however, the only FDA-approved stem-cell based products remains those that use blood-forming stem cells derived from umbilical cord blood.

The lawsuit came after the U.S. Stem Cell Clinic maintained that it was not required to follow FDA regulations. The clinic refused to let FDA investigations enter the building for an inspection, which is a violation of federal law. The FDA also had evidence that the clinic was not implementing necessary procedures to prevent product contamination, putting patients at an increased risk for dangerous infections. In the ruling, the federal judge wrote that there was “a reasonable likelihood that the clinic would continue to violate the law.”

What will this verdict accomplish?

Originally, the verdict was seen as a monumental turning point in the FDA’s struggle to regulate the stem-cell therapies on today’s market, which continue to be aggressively marketed and used on vulnerable patients with serious illnesses. In reaction to the verdict, U.S. Stem Cell said it planned to follow the federal judge’s ruling and would no longer sell the fat-based procedure. Later, though, U.S. Stem Cell announced that while it will not be performing fat-based procedures, it will continue offering stem cell treatments that rely on bone marrow and other tissues.

On top of that, the stem cell industry is booming. While in 2009 there were only two stem cell clinics in the U.S., there were at least 700 in 2017. Today, it is estimated that there are over 1,000 stem cell clinics across the nation. One company, Liveyon, has had its stem cell treatments linked to life-threatening infections in at least 15 patients. Because the ruling only applies to U.S. Stem Cell, the FDA will need to sue hundreds of clinics in the nation – around 500 of which use similar fat-based procedures as U.S. Stem Cell – to obtain the legal rights to regulate them.

What the verdict does have the power to do, however, is help the FDA win future claims against stem cell companies that they go up against in court. Currently, a second federal court lawsuit is ongoing against Cell Surgical Network, which has over 100 stem cell clinics across the nation. The trial is set to begin on Oct. 1, 2019, in California.