While stem cell research once promised groundbreaking medical treatments, the lack of a regulatory framework has allowed a predatory wellness industry to market unproven and dangerous stem cell therapies as cure-alls. In the late 90s and early 2000s, stem cells were everywhere: splashed across headlines, policy debates, and of course, research. In 1999, Science even named stem cell research as the Breakthrough of the Year.
While early research showed immense promise, the path from laboratory findings to safe, approved therapies has been bumpy. The biological intricacies of stem cells meant that clinical applications were far more limited and specific than the initial broad 'cure-all' vision. This gap between the scientific reality and public expectation created the perfect vacuum for opportunistic players to step in.
For example, the British Medical Journal recently published an investigation into businesses in the United Kingdom claiming to preserve baby teeth (“milk teeth”) for purposes of harvesting stem cells that would then be used to develop treatments for HIV/AIDS, sickle cell anemia, diabetes, cleft palate repair, and more.
“Shepherd points out that companies are selling the “potential” for something that is not yet borne out by the science. “There is a lack of evidence and a paucity of research using dental pulp stem cells to treat patients,” she says. Parents seeking tooth stem cell banking may be grappling with the diagnoses for which companies are promising future therapies, including diabetes and autism.”
This is very typical of stem cell clinics; they promise the world with little to no evidence to back it up and charge people through the nose. I've found claims for stem cell therapies for erectile dysfunction, Parkinson's Disease, cancer, and arthritis. Stem cell clinics essentially market themselves as the “We can cure your (insert condition, disease, concern here).”
In the wellness world, it's often billed as a cure-all and it sounds really science-y. This is the most malicious type of charlatan; taking science that does have legitimate uses and banking on people's basic awareness as a way to gain trust and sell services and therapies that aren't backed by science.
That mismatch between promise and practice is where questions of regulation become central.
Regulation
In the United States, stem cell therapies are regulated, though there is plenty of debate about how far the regulations lag behind where the products and marketing are. Very few stem cell therapies are FDA-approved. Despite not having FDA approval, numerous stem cell therapies are being offered and promoted by influencers, grifters, and others.
Stem cell therapies are often offered under the umbrella of “Regenerative Medicine,” attempting to assist the body in healing damaged tissues and organs. It’s often paired with other wellness terms, such as “longevity;” words and phrases inextricably linked with specific movements like biohackers, functional medicine, and wellness influencers. If you see the phrase “regenerative medicine”, you can bet you'll likely see “longevity” and “stem cells” in the marketing materials and the website.
This is one of the reasons the FDA exists: to protect us from dangerous products that aren't borne out by science and definitely don't live up to their marketing hype.The FDA issued a Consumer Alert for regenerative medicine products, which heavily focus on the use of stem cells:
“Currently, the only stem cell products that are FDA-approved for use in the United States consist of blood-forming stem cells that are derived from umbilical cord blood. These products are approved for use in patients with disorders that affect the production of blood but they are not approved for other uses.”
Even so, alternative medicine figures continue to advocate for their widespread use.
The Future of Stem Cell Therapy
Stem cell therapies are huge in the alternative medicine and wellness world. As such, it shouldn't be surprising that RFK Jr. has publicly talked about going abroad for stem cell treatments. Additionally, many of the usual suspects are also chiming in about them.
Kennedy is on the record as wanting to deregulate certain alternative therapies, including stem cell therapies.
“Mr. Kennedy vowed to end what he called the Food and Drug Administration’s war with alternative medicine. He said that would include stem cells, vitamins, peptides and chelation therapy. “And of course you’re going to get a lot of charlatans, and you’re going to get people who have bad results,” he added. “And ultimately, you can’t prevent that either way.”
This desire for deregulation is not an isolated fringe idea. Public figures like RFK Jr. have publicly advocated for loosening FDA oversight on 'alternative therapies', including stem cells. Kennedy’s position, while framed as a matter of personal choice, ironically facilitates the very 'charlatans' he acknowledges, creating a legal and ethical gray zone where scam artists can thrive without consequence.
The story of stem cells serves as a cautionary tale: a legitimate scientific breakthrough hijacked by a predatory industry. As long as these unproven therapies are marketed as a magic bullet for everything from arthritis to autism, people will continue to be harmed and financially exploited. Protecting the public from these scofflaws requires more than just consumer warnings; it demands a robust and proactive regulatory framework to ensure that promising medical science is used to heal, not to harm, and to prevent the dangerous abuse of hope for profit.
Katie Suleta, DHSc, MPH
Katie Suleta is a regional director of research in graduate medical education for HCA Healthcare. Her background is in public health, health informatics, and infectious diseases. She has an MPH from DePaul University, an MS in Health Informatics from Boston University, and has completed her Doctorate of Health Sciences at George Washington University.
