Advertising forstem cell therapies not supported by clinical researchoftenmadedirectly to patients and sometimes promoted as a cure for diseases like multiple sclerosis or Parkinsons is a growing problem that needs to be addressed and regulated, a team of leading experts say, calling suchstem cell tourism potentially unsafe.
Stem cell tourism is the unflattering name given to the practice of encouragingpatients totravel outside their home country to undergo suchtreatment, typicaly at a private clinic.
The article, titledMarketing of unproven stem cellbased interventions: A call to actionandrecently published inthe journal Science Translational Medicine, was co-authored by scientistswith universities and hospitals in the U.S., Canada, U.K., Belgium, Italy, Japan, and Australia. It focuses on the global problem of thecommercial 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 thoughthose claim often lack or are supported bylittle evidence .
They alsonoted that the continued availability of these treatments undermines the development of rigorously tested therapies, and potentially canendanger a patients life.
The researchers emphasizethat tighter regulations on stem cell therapy advertising are needed, especiallyregarding potential clinical benefits. They support the establishment ofinternational 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 Chancellors Fellow and report co-author, saidin anews 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 recommendationsfollowed the death of two children at a German clinic in 2010. The clinichas since been shut down.
Certainstem cell therapies mostly involving blood and skin stem cells have undergone rigorous testing in clinical trials, the researchers noted. A number of theseresulted in aprovedtreatments for certain blood cancers, and to grow skin grafts for patients with severe burns.
Information about the current status of stem cell research andpotential uses of stem cell therapiesis availableon the websiteEuroStemCell.
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