Experts call for regulation of unproven stem cell treatments

Graphic illustration of a cell.
Global experts want an urgent international effort to regulate stem cell tourism.

Global experts, including two University of Melbourne academics, have called for an urgent international effort to regulate potentially deadly stem cell tourism treatments.

Writing in Science Translational Medicine, 15 experts from Australia, the UK, USA, Canada, Belgium, Italy and Japan said the growing industry’s lack of regulation is putting lives at risk.

Contributors included Associate Professor Megan Munsie, a University of Melbourne stem cell scientist and co-author of Stem Cell Tourism and the Political Economy of Hope (Palgrave Macmillan), and Professor Jane Kaye, a lawyer holding positions at Melbourne Law School and the University of Oxford.

Stem cell tourism sees patients access heavily marketed but largely unproven and potentially dangerous treatments. Some travel overseas and several have died, including a woman in Australia.

The paper said the global marketing of unproven stem cell based treatments is growing in the likes of Japan, Australia and the USA, despite a lack of clinical evidence and public concern expressed by scientific organisations: “Moreover, often, providers acknowledge neither this deficit nor the potential harms to patients who receive them.”

Several countries, such as Italy and Germany, have seen action taken against stem cell treatment providers. But such examples are rare.

“Effective measures for regulating this sector both nationally and internationally are urgently needed,” the paper said.

The authors say stem cell treatments must be fully evaluated and regulated before use. Most countries, however, do not have clear rules or regulations.

“Evidence standards in the context of commercial advertising, market authorisation, and standard of care often vary considerably, as do the enforcement options available to national regulators,” the paper said.

Associate Professor Munsie said if a patient’s own cells are used, Australia’s industry is “virtually unregulated”.

"These clinics market science but are effectively selling hope,” Associate Professor Munsie said.

“We need immediate action in Australia and a co-ordinated international regulatory effort to curb this exploitative but growing industry.”