Hundreds of stem cell clinics in the United States are offering expensive treatments for conditions ranging from heart disease to orthopedic problems. But little science exists to substantiate the effectiveness or even safety of these therapies, and regulators are starting to crack down on false advertising and dangerous experiments occurring at these clinics.
Last week, New York Attorney General Letitia James filed a lawsuit against Park Avenue Stem Cell (PASC), a for-profit facility operated in New York City by plastic surgeon Joel Singer, for misrepresenting its scientific backing. The suit against PASC accuses it of giving patients the false impression that its procedures are effective, approved by the U.S. Food and Drug Administration, and endorsed by several prestigious scientific and medical organizations. In promoting the clinic, Singer makes it sound like the company conducts established research studies. At one time, its website said it engaged in patient-funded research. But, the lawsuit notes, usually universities and hospitals conduct clinical trials funded by drug developers and government agencies, not the patients who participate.
“Misleading vulnerable consumers who are desperate to find a treatment for serious and painful medical conditions is unacceptable, unlawful, and immoral,” James said in a statement.
Health insurance companies generally do not cover stem cell therapies, which they consider experimental. PASC charged patients nearly $4,000 per procedure, which used stem cells obtained from the patients’ own fat tissue. Many patients paid for multiple procedures.
More than 700 stem cell clinics like PASC have sprung up in recent years. In October, the Federal Trade Commission fined stem cell clinics millions of dollars for deceptive advertising. The FDA is trying to shut down clinics that peddle unapproved stem cell therapies, starting with those posing the biggest threat, such as doctors who inject stem cells directly into the eye or brain, former FDA Commissioner Scott Gottlieb said in a recent interview with Medscape. Officials have linked stem cell treatments to several cases of blindness and at least 12 serious infections.
But it isn’t just private, for-profit facilities that are cashing in on the new treatments. “Across the country, clinicians at elite medical facilities are lining their pockets by providing expensive placebos,” Leigh Turner of the University of Minnesota’s Center for Bioethics told Medscape.
Peter Marks, director of the FDA Center for Biologics Evaluation and Research, noted a broad spectrum of stem cell therapy providers exists, ranging from legitimate university scientists leading rigorous clinical trials to doctors who promote stem cells “for just about anything.” Hospitals operate somewhere in the middle, he said.
The FDA said stem cell therapies potentially hold great promise for the future, and it remains committed to advancing the field of cell-based regenerative medicine. “We’re implementing new policies to make it more efficient to safely develop these promising new technologies,” the agency said in a statement. “At the same time, we’re also focusing more resources on enforcement when we see companies skirt safety measures and put patients at risk.”