Experts Call for Tighter Regulation of Stem Cell Therapies in Use at Clinics Worldwide
Advertising for stem cell therapies not supported by clinical research — often made directly to patients and sometimes promoted as a “cure” for diseases like multiple sclerosis or Parkinson’s — is a growing problem that needs to be addressed and regulated, a team of leading experts say, calling such “stem cell tourism” potentially unsafe.
Stem cell tourism is the unflattering name given to the practice of encouraging patients to travel outside their home country to undergo such treatment, typicaly at a private clinic.
The article, titled “Marketing of unproven stem cell–based interventions: A call to action“ and recently published in the journal Science Translational Medicine, was co-authored by scientists with universities and hospitals in the U.S., Canada, U.K., Belgium, Italy, Japan, and Australia. It focuses on the global problem of the commercial promotion of stem cell therapies and ongoing resistance to regulatory efforts.
Its authors suggest that a coordinated approach, at national and international levels, be focused on “engagement, harmonization, and enforcement in order to reduce risks associated with direct-to-consumer marketing of unproven stem cell treatments.”
Treatments involving stem cell transplants are now being offered by hundreds of medical institutions worldwide, claiming efficacy in repairing tissue damaged by degenerative disorders like MS, even though those claim often lack or are supported by little evidence .
They also noted that the continued availability of these treatments undermines the development of rigorously tested therapies, and potentially can endanger a patient’s life.
The researchers emphasize that tighter regulations on stem cell therapy advertising are needed, especially regarding potential clinical benefits. They support the establishment of international regulatory standards for the manufacture and testing of human cell and tissue-based therapies.
“Many patients feel that potential cures are being held back by red tape and lengthy approval processes. Although this can be frustrating, these procedures are there to protect patients from undergoing needless treatments that could put their lives at risk,” Sarah Chan, a University of Edinburgh Chancellor’s Fellow and report co-author, said in a news release.
Chan and her colleagues are also calling for the World Health Organization to offer guidance on responsible clinical use of cells and tissues, as it does for medicines and medical devices.
“Stem cell therapies hold a lot of promise,” Chan said, “but we need rigorous clinical trials and regulatory processes to determine whether a proposed treatment is safe, effective and better than existing treatments.”
According to the release, the report and its recommendations followed the death of two children at a German clinic in 2010. The clinic has since been shut down.
Certain stem cell therapies — mostly involving blood and skin stem cells – have undergone rigorous testing in clinical trials, the researchers noted. A number of these resulted in aproved treatments for certain blood cancers, and to grow skin grafts for patients with severe burns.
Information about the current status of stem cell research and potential uses of stem cell therapies is available on the website EuroStemCell.