Evidence shows regulatory crackdown makes a difference to unproven stem cell market

Collaborative research co-led by reNEW’s PREPARE Lead Professor Megan Munsie has reported that targeted action by national regulators has resulted in a considerable decline in the advertising of unproven stem cell treatments.

Professor Munsie, who is also a group leader at Murdoch Children’s Research Institute, and international colleagues have long monitored the online ‘stem cell’ marketplace.

Over the last decade, they been concerned about an increasing number of businesses engaging in direct-to-consumer marketing of “stem cell products” as treatments for wide range of diseases and injuries.

Although regulators in the U.S. and other regions have increased their efforts against these businesses, regulations have frequently fallen short of systematically and effectively controlling these markets.

However, in a paper published today in Cell Stem Cell, Professor Munsie and colleagues have reported that targeted action by national regulators has made a difference in Canada and Australia.

In both countries, the number of businesses selling unproven stem cell products on a direct-to-consumer basis declined after national regulators increased their enforcement efforts and found effective ways of responding to such commercial activity.

By monitoring the online marketplace over time, the researchers were able to show that 60% of businesses ceased direct-to-consumer advertising in both Australia and Canada between 2018 to 2023. In comparison, the marketplace in the U.S. continued to expand.

“While stem cell science holds great promise for future innovative therapies, we must still insist that evidence – not just enthusiasm – underpins progress”, said Professor Munsie.

“Until stem cell-based medicines are shown to be safe and effective, we need to stop unscrupulous businesses exploiting the hopes of patients and their families.”

Whether similar action by regulators could prove effective in other places, or if more strident action such as fines or criminal prosecutions will be required, the regulatory actions seen in Australia and Canada are encouraging.

Professor Munsie was joined in this study by Professor John Rasko AO from the University of Sydney, Associate Professor Laertis Ikonomou from University at Buffalo, Professor Leigh Turner from University of California Irvine, Carl Power from Centenary Institute, University of Sydney, and Doug Sipp from RIKEN Center for Biosystems Dynamics Research in Japan.