Stem Cell Tourism: What it signals, why it’s dangerous, and the path toward domestic access
By Jan Shultis, Ph.D.
Earlier this season, we shared a three-part series on how and why Hope Bio’s location in the United States (U.S.), in Texas, near Houston, and in Sugar Land directly affects your access to our cellular therapeutics. If you missed it, those entries are found at the links below:
Today, we look outward from the U.S., across oceans and into other countries where the overwhelming majority of global volume of mesenchymal stem cell (MSC) treatments are administered. “Stem cell tourists” are but one segment of a multi-billion-dollar “medical tourism” industry in which individuals travel to other countries (in the context of this conversation, outside of the United States) to access medical and healthcare of all kinds, including for sports performance and injury recovery, cosmetic purposes, and in hopes of bettering disease and illness conditions. A 2021 literature review concluded the most common conditions for which individuals pursue stem cell tourism include multiple sclerosis (MS), anti-aging, Parkinson’s Disease, stroke, spinal cord injury, cerebral palsy, autism, amyotrophic lateral sclerosis (ALS), Alzheimer’s Disease, and arthritis.[1]
Why location matters
There are pristine labs, talented physicians, and driven scientists in every part of the world who love the people they serve, are dedicated to advancing technology, and generally offer stellar healthcare. Access to cellular therapeutics, in particular, is far more legally and logistically straightforward in other countries. Why, then, the assertion that treatment in the United States is desirable?
The problem (and it is a problem) is not a complete lack of reputable or trustworthy clinics anywhere in the world other than the U.S. The problem (and again, it is a problem from a patient or client perspective) is that the rest of the world lags far behind the U.S. in regulatory and consumer practice protections for investigational products. Direct-to-consumer marketing and follow-on administration of those products to sick and injured Americans opens the door to a host of safety, financial, and other potentially harmful scenarios that are likely to be avoided through treatment in the U.S., under U.S. laws.
Hope Biosciences is candid about what we perceive to be needed areas of updating, refinement, and general improvement in U.S. biologics regulations pertaining to adult cellular therapeutics. Because regulation affects access and patient safety, we talk about these and related issues frequently in videos like these:
The U.S. regulatory system is a double-edged sword. On one hand, upholding regulatory practices drives up development costs astronomically (think double-digit millions to complete clinical trials), restricting access to promising therapeutics for years longer than some patients have or are willing to wait, and arguably slows progress compared to work in other countries. The process is so cumbersome that it is not uncommon for American scientists to go overseas to pursue work in promising therapeutics, simply to progress something they believe in during their academic lifetimes. On the other hand, frustrating though it can be, that same regulatory framework is in place to ensure patient safety.
The sheer volume of treatments sought by Americans outside of our own country signals several things:
Real people, with real needs, are indicating they have a desire for access to cellular therapeutics that is sufficiently strong to motivate them to navigate the risks of overseas treatment.
Real people, with real needs, are indicating that those desires are, from their perspective, more easily or readily met outside of the U.S., whatever the cost or risk.
If one believes countries and governments philosophically exist to serve and support people, then considering the first two points, U.S. regulatory practices must continue to be scrutinized to promote access and in so doing, reduce access costs.
While that process of regulatory refinement progresses, manufacturers dedicated to extending treatment in the U.S., like Hope Biosciences, are vitally important in making treatment available to people in need, now.
Safety, vulnerable patient populations, and scientific progress
The largest risks associated with stem cell tourism center on the fact that outside of FDA-regulated access pathways, patients cannot know what, exactly, they are receiving. Specific to cellular therapeutics, “outside of regulation” also means outside of required disclosure of treatment contents, including but not limited to cell quantity, viability, quality control testing procedures, or anything else; and outside of mandated disclosure of possible treatment risks or negative effects. Language barriers can further complicate the process, especially in instances of adverse events, when a patient may find themselves navigating a foreign healthcare system during a healthcare emergency. Should something go other than envisioned, there are no avenues to legal or financial recourse, or even clinical investigation to protect future patients.
Though it is athletes and celebrities who make most of the headlines about stem cell tourism, the majority of people undertaking such trips are “everyday people” battling chronic degenerative disease. Sick people are inherently vulnerable and, by the time they consider stem cell tourism, often mentally, emotionally, and physically exhausted by the strain of living with and navigating chronic disease or sudden injury. This is a population of people vulnerable to fraud and abuse, both financial and medical. In addition to immediate impact, sick or injured people can be further harmed by indirect effects such as postponement of evidence-based treatments in favor of overseas promises, often at great financial cost.
While no individual bears the burden of “advancing science,” it is also true that when a patient seeks treatment overseas instead of through U.S. regulated pathways, their data goes with them. If something “works,” it works only for them. Nothing was recorded, validated, or tracked, and so nothing in that experience helps develop medical treatment for all of the other people in the nation or the world who may face the same condition; in the case of chronic degenerative disease with a genetic component, future patients may very well include the current patient’s family or loved ones. Treating that same patient here in the United States, producing reams of data and clinical study, then leveraging those results in increasingly larger trials, can change the face of medicine and healthcare in our country. Overseas treatments can represent scientific advancement opportunities lost.
Domestic access
It is possible to access stem cells in the United States, including through clinical trials, Expanded Access protocols, and the federal Right to Try program. Hope Biosciences remains dedicated to enlarging and easing access through focused work in the U.S., through U.S. regulatory pipelines. We will continue to pursue all means at our disposal, including special programs like Regenerative Medicine Advanced Therapy (click here for news of a recent “first” for Hope Bio), while we grow the body of validated data about our proprietary therapeutics.
As of this writing, it is fair to acknowledge that it can be more difficult to access your stem cells in the United States than abroad. Should your stem cells be as or more readily available to you in your country of residence, than they are in another country? We believe so. That is exactly the future Hope Biosciences fights for, one FDA-authorized treatment at a time.
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[1] Lyons S, Salgaonkar S, Flaherty GT. International stem cell tourism: a critical literature review and evidence-based recommendations. Int Health. 2022 Mar 2;14(2):132-141. doi: 10.1093/inthealth/ihab050. PMID: 34415026; PMCID: PMC8890798.
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