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. There’s already one major and proven application of stem cell therapy in wide use today: bone marrow transplants that can restore a person’s supply of healthy blood cells. But scientists speculate that these treatments could help with many more conditions, including spinal cord injuries, Alzheimer’s disease, and heart disease.
The promise of stem cells is real. But in the last two decades, there’s 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 doesn’t fall under the umbrella of being a novel, and thus unlicensed, treatment.
Leigh Turner, a bioethicist at the University of Minnesota, 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, he’s 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 products — a 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.
“It’s not just self-described stem cell clinics selling such interventions. Ortho, pain, wellness, sports medicine, spine, podiatry, chiropractic, naturopathic, integrative medicine, cosmetic, and anti-ageing clinics are now all in the business of advertising stem cell procedures,” he told Gizmodo in an email. “We’re witnessing the triumph of the peddler and the huckster over evidence-based medicine.”
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, he’s even found a few that are marketing stem cell “immune boosters” as a prophylactic against covid-19.
Though there may be more rationale in using stem cells for some of these conditions than others, there’s 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 report found 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 others’ charity. And aside from the direct harm these places are causing, Turner says, there’s 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 Turner’s opinion, regulatory agencies like the FDA and Federal Trade Commission are still far too timid about using the legal tools at their disposal.
“Right 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.” he said. “A 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.”
Turner does note that some states are becoming more cognisant 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 promised to 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.
“There has not yet been anything approaching a true ‘crackdown’ in response to this marketplace,” he said. “It’s possible we will see more systematic, comprehensive efforts on the part of the FDA, though I wouldn’t encourage anyone to hold their breath while they wait.”