Taking advantage of regulatory grey areas, unlicensed stem cell clinics have proliferated over the last decade in countries such as the US and Canada.

These clinics offer procedures that have not been clinically proven for a vast range of conditions and rely on advertising claims, which elevate the potential benefits and minimise the risks of stem cell treatment, according to research by University of Minnesota Center for Bioethics associate professor Dr Leigh Turner.

Turner has been researching unlicensed stem cell clinics in North America since 2012. He identified there were 351 businesses operating a total of 750 stem cell clinics across the US in a large study in 2016 and 30 Canadian businesses operating 43 clinics in a 2018 study.

As such, the US and Canada now have significant direct-to-consumer marketplaces for unproven products, which are potentially life-threatening and could be hindering progress in legitimate stem cell research.

Understanding how unlicensed stem cell clinics operate

Turner explains that since these procedures are not controlled by clear regulations, “the [companies in the] marketplace make their own assessment on how these products should be classified, and they will choose the option that doesn’t involve conducting clinical trials” by claiming it does not require investigational new drug approval from the US Food and Drug Administration (FDA) or Health Canada.

The clinics then market their products through “overemphasising the possibility of benefit and minimising any possibility of risk.”, Turner says. “They advertise primarily through patient testimonies, which are largely anecdote- driven and sometimes offer before and after narratives.”

Turner describes this as a “very manipulative and dishonest strategy”, especially as the procedures are not backed by scientific evidence. It goes against the basic notion of informed consent that “doctors, will make informed advice about benefits and risk and won’t exaggerate benefits and won’t minimise the possibility of risks.”

Although many companies use scientific language and emphasise the professional organisations their clinicians are members of, some companies have gone a step further to mislead patients about the clinical evidence behind stem cell procedures by listing what Turner describes as “junk studies” on ClinicalTrials.gov as a form of marketing.

He explains: “People go on ClinicalTrials.gov, they search for a stem cell procedure related to their disease, and they find a study with a link to the business itself. Well into the conversation [with the stem cell clinic], the patient finds out it is going to cost them $20,000 or $30,000, when they thought they were accessing a clinical trial where participation would be free.”

Risks of unproven stem cell treatments to patients

Patients are unsurprisingly drawn in by these marketing strategies due to their desperation for new, effective treatments for their conditions, and they opt to pay out of their own pocket for treatments that are not proven to treat or mitigate symptoms of diseases.

Turner has found that companies and clinics are very secretive about what they charge patients, but he notes that “we know from court cases that people end up spending thousands or tens of thousands of dollars” on unproven stem cell therapies.

Although there is an assumption that the patients undergoing these procedures must be wealthy enough to afford the price tag Turner explains that in fact, “Many individuals have limited financial resources. They go on to crowdfunding websites, establish a campaign page, and hope that others will provide donations to help.” These crowdfunding campaigns help to spread misinformation about the efficacy and safety of stem cell treatments as they mimic the marketing claims of the unlicensed clinic.

Even worse than being thousands of dollars out of pocket for a procedure that has no proven medical benefit, there are many examples where patients have been harmed and died as a result of stem cell treatments.;

“There is evidence of blindness, possibility of pulmonary embolism, possibility of a growth or mass of some kind,.” says Turner.

Turner argues there are unknown risks of “putting cells into a part of the body where they don’t belong, cells not being processed properly and… contamination,” and it is very concerning that the procedures are sometimes performed by “doctors operating far outside the remit of their training”.

Patients have actually begun to sue stem cell clinics to settle allegations of fraud and misrepresentation in advertising, as well as harm as a result of procedures.

Hindering progress in legitimate stem cell research

In addition to the dangers they pose to patients, Turner says there is a fear these unlicensed stem cell clinics and procedures may change the “public perception of stem cells and stem cell research”, which could hinder genuine scientific progress in the area.

However, Turner notes legitimate stem cell research is also hindered by researchers “losing large numbers of individuals to this direct- to- consumer marketplace” who could have been recruited into clinical trials with a proper scientific basis and parameters in place to protect patients from harm; recruitment is generally one of the biggest challenges in all clinical research.

He explains: “If you have two or three clinics this wouldn’t really matter, but if you have over 700 clinics in the US, if so many people go to those businesses, they get pulled away from going into clinical trials where we might learn something.”

Regulators must wake up to unlicensed stem cell risks

Despite court cases being filed against unlicensed stem cell clinics, Turner says the problem is persisting and new companies continue to emerge.

Turner’s 2018 study found no evidence of either Health Canada or professional medical organisations taking disciplinary action against companies or doctors engaged in the unlicensed stem cell marketplace.

The situation with the FDA and the US is similar, as Turner explains. “When I first began studying [unlicensed stem cell treatments], the FDA was really not doing anything, it was standing on the side-lines,” he says. “Now the FDA is more aware [and] has indicated that it intends to step up its enforcement activity.” – whichThis begs the question, asked in Turner’s 2016 study, whether inaction by regulators has only emboldened these companies.

Turner argues that the most effective strategy to clamping down on this unlicensed stem cell marketplace is to “better enforce existing regulations” and this needs to come from health regulators like the FDA and Health Canada , as well as advertising regulators that deal with issues surrounding false marketing claims.

Regulators simply saying they are going to step up enforcement “doesn’t seem to act as a deterrent, the marketplaces continues to grow”, Turner notes.

With patient safety and the legitimacy of a potentially revolutionary research area under threat from unscrupulous stem cell clinics, proper accountability and enforcement is urgently needed.

Shining a regulatory spotlight on this illegal, murky corner of regenerative medicine will be the best way to separate promising research projects from clinics thriving on bogus claims and seizing advantage of lax oversight.