Beware the Corner Clinics That Peddle Stem Cells

Stem-cell therapies hold enormous promise, but most are in early stages of
development. Don’t just buy them off the street
March 10, 2019 12:00 AM
J. Peter Rubin and William R. Wagner

Heart disease? Multiple sclerosis? Arthritis? How about chronic lung disease or even hair loss? Stem cells can cure all of these conditions! At least that’s what the advertisements, prominently displayed on billboards and colorful websites, claim. This leaves one wondering if the entire stem-cell-therapy field is real or just modern-day snake oil. Stem cells are found in embryos and give rise to all the tissues in the body. Stem cells can also be derived from a patient’s own tissue, such as bone marrow or fat. There are two major features of stem cells that make them attractive for the treatment of diseased or injured tissues. First, stem cells have the ability to release growth factors, or chemical signals, that assist in biologic healing processes. Second, stem cells can transform into any new tissue type to potentially rebuild a failing organ such as the liver. While stem-cell technology has been used experimentally to heal muscle injuries or speed recovery from stroke and heart attack, the science is still relatively new and evolving. Most therapies are at a very early stage. So why, then, do we see such visible marketing offering stem-cell therapies and what do we know about the therapies being advertised?

Most of the advertisements you see are posted by increasingly prevalent for-profit private clinics. There are about a dozen in the Pittsburgh region, advertising stem cells as a cure for a broad variety of disorders, typically outside of the provider’s scope of expertise. For example, a physician without specific expertise in neurologic disorders offers stem-cell therapy for multiple sclerosis. These cell-based therapies are so plentiful because they’re relatively simple to administer. Many can be performed in an office setting with minimal anesthesia during a single visit, but they have not been thoroughly assessed for risks, and there is documented evidence of possible side effects without evidence of successful therapeutic outcomes. So why isn’t the Food and Drug Administration shutting these clinics down? Under the 21st Century Cures Act, signed in December 2016, the FDA opened accelerated pathways to bring cell-based therapies safely to the clinic, and the agency last month finalized its guidance documents to expedite the process. But the legislation did not provide for stricter control of clinics
functioning outside FDA guidelines. The smaller ones just fly under the radar. The FDA simply does not have the resources to investigate every clinic in the United States — there may be more than 700 — although action is being taken against some very high-profile ones. There have been calls for increased oversight at the state level, and while California has enacted a law requiring practitioners to inform their patients that stem-cell therapy is not FDA-approved, so far no
legislation has been proposed in Pennsylvania. In the meantime, it’s a buyer beware situation. The practitioners running these clinics often argue that they are simply “practicing medicine,” and the FDA does not oversee the practice of medicine. This is actually not true when it comes to cell- and tissue-based therapies that are removed from a human with the intention of transplanting those cells or tissue into another (or the same) human; the FDA has a robust set of regulations governing these practices. This is federal law.

Patients ask, “But what about my own cells? They’re mine and the government can’t control them, right?” Of course your cells are your own, but whenever tissue is removed from the body and reimplanted, a set of federal regulations applies. These regulations are designed to ensure that the tissue is handled in a way that will not pose a safety risk if implanted in a patient. The good news is that there is exciting and credible science being developed in the field of stem cells and regenerative medicine. As we move forward, our progress should be characterized by positive, evidence-based outcomes rather than being mixed with stories about “rip-offs” and adverse consequences due to premature applications. The best way to advance the field is through the coordinated efforts of experienced investigators working in concert with the FDA and other regulatory bodies — including increased oversight at the state level — to develop safe and effective
treatments.

The McGowan Institute will host a panel discussion, “Stem Cell Therapies: Hope vs. Hype,” on March 12 from 4-6 p.m. at the Pitt University Club, Ballroom B, 123 University Place, in Oakland. J. Peter Rubin, M.D., is UPMC Endowed Professor and chair of the University of Pittsburgh Department of Plastic Surgery. William R. Wagner, Ph.D., is director of the university’s McGowan Institute for Regenerative Medicine.