Canada, Australia making strides toward regulating predatory stem cell products

Over the past decade, a number of U.S. clinics have marketed stem cell products directly to consumers as purported treatment for a host of diseases and injuries. The problem, notes UB faculty member Laertis Ikonomou, is that many of these interventions have scant proof of efficacy or safety.

“While there have been efforts to regulate the stem cell market in the U.S., including distributing warning letters and official documents from the Food and Drug Administration, they haven’t been effective,” says Ikonomou, associate professor of oral biology in the School of Dental Medicine.

Instead, the number of documented businesses that market directly to consumers has grown significantly — from 351 in 2016 to 1,480 in 2021, according to the journal Cell Stem Cell in an article published in November 2021.

Meanwhile, Australia and Canada have experienced recent success with targeted regulatory action.

Ikonomou documented this phenomenon as the lead author on an article published in the Oct. 3 issue of Cell Stem Cell. Researchers from universities and research centers in Irvine, California; Sydney and Melbourne, Australia; and Kobe, Japan, served as co-authors.

“In both Canada and Australia, 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,” says Ikonomou, who has studied this practice for several years.

By monitoring the online marketplace over a five-year period, the researchers found that 60% of businesses in Canada and Australia ceased direct-to-consumer advertising. In 2023, only 12 businesses in Australia and three in Canada continued to explicitly offer “stem cell” treatments.

The hope is that national regulators in the U.S. and other countries could use similar methods to eradicate predatory stem cell practices, he says.

In the United States, clinics have been targeting consumers through slick websites and television advertisements, Ikonomou explains. They frame the therapies as legitimate treatment for conditions ranging from musculoskeletal diseases and injuries to neurological disorders primarily for quick financial gain.

“Sometimes the clinic operators are the subject of regulatory action and then stop and switch to something else,” Ikonomou says. “There is a lot of movement in and out of this marketplace.”

The clinics offer treatments for numerous conditions, including progressive ones such as Parkinson’s or Alzheimer’s disease that can significantly diminish quality of life. Often, patients come to the clinics from a place of desperation.

“These clinics are preying on people who feel like they have no other choice,” Ikonomou says. “In the best-case scenario, they are spending too much money for ineffective treatments. In the worst cases, patients have ended up with bad side effects or worsened conditions.”

Not that long ago, consumers in Canada and Australia were dealing with the same unsavory practices that are being experienced in the U.S. A 2018 study in Canada detailed the growth of this domestic market of stem cell therapies and the lack of regulatory response. This included ambiguities in exemptions from federal oversight for minimally manipulated and homologous-used autologous cells.

“Physicians were the main purveyors of such interventions, with autologous so-called stem cells offered for a variety of conditions ranging from multiple sclerosis to diabetes,” Ikonomou says.

The following year, Health Canada issued an advisory emphasizing the risk posed to consumers by unproven stem cell treatments. It also issued “cease and desist” letters to 36 Canadian clinics marketing unproven stem cell products.

Meanwhile, Australia put the regulation of stem cell products under the purview of the main national regulator, the Therapeutic Goods Administration, and reinforced a ban on direct-to-consumer advertising of these products.

“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,” Ikonomou says. “It’s time for other national regulators to act, using the variety of tools at their disposal to stamp out the predatory stem cell marketplace and reduce the risk of patients being exposed to physical and financial harms.”