The U.S. Food and Drug Administration is proposing to get tougher on clinics that offer unapproved stem cell therapies, and is hosting a critical public hearing on the issue Monday and Tuesday in Bethesda, Md.
A study published recently in the journal Cell Stem Cell found that 570 clinics across the country are offering pricey stem cell treatments for both cosmetic and medical purposes. The clinics claim to treat a wide variety of problems, from spinal cord injuries to autism.
“There are clear grounds for concern that some of the companies we found are not compliant with federal regulations,” they wrote.
Many of these clinics say they use stem cells derived from patients’ own fat. They argue their treatments are exempt from the agency’s rigorous approval process because the fat cells are “minimally manipulated” and shouldn’t be classified as drugs subject to FDA regulation.
But late last year, the FDA sent a warning letter to a doctor saying that the processing of fat cells in his clinics, including one in California, “would not meet the definition of minimal manipulation” and his product was therefore considered a drug that required agency approval.
Nearly 100 stem cell clinics, doctors, researchers and organizations plan to testify at the hearing about these issues.
California Healthline interviewed three participants, with divergent views, all California-based experts whose professional lives revolve around stem cell science.
Jeanne Loring is a professor and stem cell researcher at The Scripps Research Institute in La Jolla. She supports tighter FDA controls.
Elliot Lander is co-medical director and co-founder of Cell Surgical Network, a Rancho Mirage, California-based group comprising about 100 stem cell clinics, most of them in the U.S. He is wary of the FDA’s plan for more regulation.
C. Randal Mills is CEO of the California Institute for Regenerative Medicine, the state’s stem cell agency, based in Oakland. He calls for a middle ground between the FDA’s strict approval process and total exemption from that process.
The transcript below has been edited for length and clarity.