The ISSCR is pleased that federal prosecutors in the U.S. have taken action to halt the marketing and delivery of unproven stem cell treatments at clinics they allege are operating outside of FDA regulation: California Stem Cell Treatment Center, Cell Surgical Network Corporation, and U.S. Stem Cell Clinic in Florida. According to court filings announced by the Department of Justice and the FDA, these clinics have been offering stem cell interventions whose safety and effectiveness have not been established in clinical trials, nor have they gone through the FDA approval process. If true, these clinics put patients at unknown risk, and elude regulatory authority. A number of Americans have already been blinded or paralyzed from unproven stem cell treatments, some of which were marketed in a way that caused patients to believe they were participating in legitimate clinical trials.
“Holding clinics responsible for violating regulations will put others on notice that they can no longer operate outside the Comprehensive Regenerative Medicine Policy Framework set forth by the FDA last year,” said ISSCR president Hans Clevers. “We’re pleased that the FDA is enforcing these guidelines, and hope this legal action will send a firm message to the many rogue clinics pedaling unproven stem cell interventions that they are not above the law,” he said.
The ISSCR has long been concerned with the proliferation of clinics offering stem cell interventions that have little basis in science or medicine and that prey upon the hopes of desperate patients. The organization offers its assistance and scientific expertise to governments and regulatory authorities worldwide as they try to curtail this problem.