Crackdowns on Unproven Stem Cell Therapies Worked Abroad

Evidence from Australia and Canada indicated that regulation can help to curb the sale of unproven stem cell therapies, researchers found.

Direct-to-consumer marketplaces experienced “marked decreases” in the number of companies selling such products following the introduction of regulatory reforms in both countries, reported Leigh Turner, PhD, of the University of California, Irvine, and colleagues.

In Australia, for example, medical regulators tightened rules over the advertising and provision of autologous cell and tissue products in 2018. These reforms clarified that direct-to-consumer marketing of such products is prohibited, and that reporting adverse events associated with the use of such products is mandatory.

In North America, Health Canada issued cease-and-desist letters to 36 clinics marketing unproven stem cell therapies in 2019.

By 2023, the majority of stem cell companies operating in either country had either disappeared from the internet or shed their old, unproven marketing claims, Turner and colleagues reported in Cell Stem Cell.

“While such research faces inevitable limitations in its ability to establish causality, we observed that regulatory actions in both countries were followed by a distinct pattern of change: a reduction in the size of markets, a shift in the types of biologics advertised, and a tempering of marketing claims,” Turner and colleagues wrote.

They reported that in Australia, there were 12 companies still marketing unproven stem cell therapies in 2023, down from 35 in 2018. The holdouts promoted treatments “merely described as ‘regenerative’ or else retained the term ‘stem cells’ within the business name or a proprietary product,” they noted, adding that there also was a “marked decrease” in companies offering undefined stem cells and fat-sourced cells.

In Canada, only four companies continued marketing stem cell therapies or used the term in their name by 2023. Most companies that continued operating following the cease-and-desist letters by Health Canada “no longer explicitly advertised stem cell treatments,” Turner and colleagues reported.

“These findings provide an important counterexample to the comparatively poor regulatory results in the U.S. and many other countries,” study authors wrote. “They lend further support to the notion that focused government actions can reduce the activity and scale of predatory health markets.”

However, the Canadian data showed that while there was a “marked decrease” in cells sold online as derived from bone marrow or fat, marketing of platelet-rich plasma (PRP) therapies declined “only slightly over the same period,” they added. Twelve out of 30 companies ceased marketing any type of cell-based products or PRP by 2023.

Ultimately, there “can be powerful financial incentives to keep this marketplace activity going,” Turner told MedPage Today. These businesses “need a clear signal that the party is over,” and that there are “going to be real consequences.”

“While lessons from Australia and Canada cannot be rigidly applied to countries with different legal traditions, regulatory frameworks, and political cultures, these two countries can serve as helpful models of how regulators should respond to businesses selling noncompliant nominal stem cell and other purported regenerative medicine products,” study authors wrote.

Stateside, companies and clinics operating in this space represent a “tremendous scale,” Turner noted. He added that it “may take a lot more activity in the U.S. to have the kind of systemic effect” observed in Australia and Canada. Diverse regulatory strategies and monitoring may be warranted.

There is the possibility that without “long-term vigilance,” companies will “continue to morph,” Turner said. Businesses can be “very adept” when it comes to changing their marketing, he said, and they may introduce new misleading representations in the marketplace.

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