PATIENTS have been warned of the dangers of seeking "unproven stem cell therapies" abroad as experts called for a tighter regulation of health tourism.
International experts in public health, ethics and biotechnology, said countries should unite to tackle "unscrupulous marketing" of potentially harmful experimental therapies, and warned that emerging biotechnologies such as mitochondrial replacement therapy and gene editing were also at risk of misuse.
Their editorial is published in the US-based journal, Science Translational Medicine.
Hundreds of clinics worldwide are selling stem cell transplants to treat everything from Parkinson's disease to spinal injuries, but it is generally banned in Europe outwith trials or in exceptional circumstances.
Dr Sarah Chan, an expert in ethics from Edinburgh University, said: “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. 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.”
It comes days after the Herald reported on the case of Lucy Clarke, from Inverness, who said she had experienced a major reduction in her MS symptoms after undergoing a stem cell transplant in Moscow. Mrs Clarke is now supporting the efforts of her friend and fellow MS sufferer Rona Tynan, also from Inverness, to fundraise £60,000 to undergo the same procedure in Mexico.
The treatment, known as AHSCT, uses intensive chemotherapy to strip away patients' faulty immune system before flooding their bodies with stem cells harvested from their own bone marrow. It is being tested in the UK in clinical trials in London and Sheffield, but a small number of MS patients have also undergone the treatment "off-trial" on the NHS.
The journal article follows controversy over the XCell clinic in Germany where a 10-year-old boy from Azerbaijan was seriously injured in 2010 after having stem cells injected into his brain, and an 18-month-old from Italy died three months later after the same procedure. The facility was shut down in 2011.
The editorial states: "The term 'stem cell' has been used broadly in promises of youth, rejuvenation, and good health, as well as in the branding of cosmetics, dietary supplements, and sports products.
"Such hyperbole carries with it not only an increased risk of exploitation of vulnerable patients and their families desperate for a cure but also of significant damage to the health of those subjected to these unproven interventions. In the longer term, unfulfilled promises may bring regenerative medicine research and development into disrepute."
The authors call for the World Health Organization to help guide responsible clinical use of stem cells, adding: "The success of this industry has adverse implications for patients’ health and the integrity of health care markets, as well as potential repercussions for legitimate biomedical endeavours. It also provides an unsettling glimpse of what may lie ahead for other emerging biomedical technologies, such as mitochondrial replacement therapy and gene editing."
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