Sick people seeking unproven stem cell treatments are putting their lives at risk, experts warn, amid calls to urgently tighten global regulations on the potentially deadly "stem cell tourism treatments".
Stem cell tourism sees patients buy heavily marketed but largely unproven and potentially dangerous treatments. Some travel overseas and several have died, including a woman in Australia.
Writing in Science Translational Medicine, 15 experts from Australia, the UK, U.S, Canada, Belgium, Italy and Japan say the global marketing of unproven stem cell based treatments is growing in the likes of Japan, Australia and the U.S.
This is 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," the paper read.
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.
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 Megan Munsie
"We need immediate action in Australia and a coordinated international regulatory effort to curb this exploitative but growing industry."
Australian authorities issued warnings about unproven stem cell treatments in 2014 after Brisbane mother-of-two Kellie van Meurs died of a heart attack while undergoing the treatment for a rare neurological disorder in Moscow, Russia.
What The Therapeutic Goods Administration Says About Unproven Stem Cell Treatments
- An unproven stem cell treatment may also pose serious, potentially fatal, risks to your health including infection, allergic reactions, rejection of the cells by your immune system and the development of cancer.
- Unproven stem cell treatments may cause financial hardship, including treatment and ongoing follow-up costs, as well as the cost of emergency medical care in the event that something goes wrong. If you undergo treatment outside Australia, there are additional costs associated with travel.
- Importantly, undergoing an unproven stem cell treatment may interfere with proven and potentially beneficial therapies recommended by your general practitioner or specialist. It can also disqualify you from participation in a registered clinical trial.
Some countries, such as Italy and Germany, have reportedly taken action against stem cell treatment providers. But the authors say such examples are rare.
"Effective measures for regulating this sector both nationally and internationally are urgently needed," the paper read.
The authors said 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 read.
Some treatments using blood and skin stem cells have been rigorously tested and found they could treat certain types of cancer and grow skin grafts for burns patients.
But other potential therapies are only in the earliest stages of development and have not been approved.
"Stem cell therapies hold a lot of promise, but we need rigorous clinical trials and regulatory processes to determine whether a proposed treatment is safe, effective and better than existing treatments," one of the 15 experts, Sarah Chan of Britain's University of Edinburgh, told Reuters.
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