Sketchy clinics selling untested and often illegal stem cell treatments in the U.S. are proliferating, new research out Thursday has found. It estimates that the number of businesses offering stem cells for everything from back pain to protection against covid-19 has more than quadrupled since 2016. This rise has happened despite patients being grievously hurt and the Food and Drug Administration pledging to crack down on the industry.
Stem cells have the potential to become every other cell in the human body. The long-standing hope has been that stem cells can be collected from people, grown and possibly tweaked in the lab, and then used to treat often incurable injuries or ailments. Thereâs already one major and proven application of stem cell therapy in wide use today: bone marrow transplants that can restore a personâs supply of healthy blood cells. But scientists speculate that these treatments could help with many more conditions, including spinal cord injuries, Alzheimerâs disease, and heart disease.
The promise of stem cells is real. But in the last two decades, thereâs been a shady industry promoting these treatments to consumers directly, often by making claims far beyond the current science supporting their use. And while doctors and clinics can treat patients with stem cells as part of legitimate and experimental research, many of these stem cell shops are doing so by skirting current FDA regulations. Many places, for instance, will wrongly argue that their use of stem cells doesnât fall under the umbrella of being a novel, and thus unlicensed, treatment.
Leigh Turner, a bioethicist at the University of California, Irvine, has been keeping an eye on the direct-to-consumer stem cell industry for over a decade now. And in his latest paper, published in the journal Cell Stem Cell, heâs documented the burgeoning growth of the field.
With the help of online data mining techniques, including the use of Google Maps, Turner estimated that, as of March 2021, there were at least 1,480 businesses operating 2,754 stem cell clinics in the U.S., all selling unlicensed and unproven stem cell productsâa sharp rise from the 351 businesses and 570 clinics he and others previously estimated were around in 2016.
The sheer ballooning of the industry is worrying enough, Turner notes, because it means that regulation will be that much harder. But the industry has morphed in other ways that are concerning, he said.
âItâs not just self-described stem cell clinics selling such interventions. Ortho, pain, wellness, sports medicine, spine, podiatry, chiropractic, naturopathic, integrative medicine, cosmetic, and anti-aging clinics are now all in the business of advertising stem cell procedures,â he told Gizmodo in an email. âWeâre witnessing the triumph of the peddler and the huckster over evidence-based medicine.â
These clinics, Turner observed, are marketing stem cells as the cure for various forms of pain, erectile dysfunction, and diabetes, among many other diseases; some are also offering to treat autism and cerebral palsy in children. And more recently, heâs even found a few that are marketing stem cell âimmune boostersâ as a prophylactic against covid-19.
Though there may be more rationale in using stem cells for some of these conditions than others, thereâs simply no way to tell if these treatments are doing any good. But there have been many instances of stem cell clinics objectively harming their patients. A recent Pew reportfound over 300 claims of injury and deaths linked to these clinics documented since 2004, which is almost certainly an underestimate. Patients are also forking over thousands for treatments that may not even contain viable stem cells at all, sometimes at the expense of their life savings or othersâ charity. And aside from the direct harm these places are causing, Turner says, thereâs the harm done to legitimate stem cell research, since many of these patients could have been recruited by ethically conducted clinical trials.
The FDA has been more vocal about stem cell clinics overstepping their bounds recently, both in warnings to the public and in enforcement against the worst offenders. But in Turnerâs opinion, regulatory agencies like the FDA and Federal Trade Commission are still far too timid about using the legal tools at their disposal.
âRight now, we have the appearance but not the reality of meaningful regulatory governance of stem cell-based interventions. Businesses, universities, hospitals, and other institutions that want to comply with applicable regulations are held to justifiably demanding standards. Meanwhile, businesses and clinics that are willing to violate federal and state regulations operate with little or no oversight.â he said. âA few of them receive warning letters or untitled letters from the DA, or perhaps attract the attention of a state attorney general or state medical board, but in general regulators do not appear to be paying close scrutiny to the rest of them.â
Turner does note that some states are becoming more cognizant of the problem and passing local laws to better regulate these places; some are even suing them. And with a recent grace period of FDA regulation on these clinics having ended this year, the FDA has again promisedto keep a tighter leash on the industry. But given his years as a watchdog and the glut of clinics now out there, Turner is less optimistic that serious change on the federal level is on the way anytime soon.
âThere has not yet been anything approaching a true âcrackdownâ in response to this marketplace,â he said. âItâs possible we will see more systematic, comprehensive efforts on the part of the FDA, though I wouldnât encourage anyone to hold their breath while they wait.â
