The increasing problem of ‘stem-cell tourism’ – patients travelling to developing countries seeking costly and unproven stem cell treatments – have prompted leading experts to join in an international effort to establish standards for the development of stem cell treatments. The 30-member committee, comprised of scientists and ethicists from 13 nations, was to release a draft guide at the International Society for Stem Cell Research (ISSCR) annual meeting in Philadelphia last week but discussions have delayed it. They now hope to have a draft ready in one month, said George Daley, president of the ISSCR, which created the task-force committee. The committee will also collaborate with patient groups to publish a shorter document of frequently asked questions to help explain the guidelines and assist individuals to evaluate the merits of advertised therapies.
The therapeutic benefit of stem cells – cells which can regenerate damaged tissue and organs – are still many years away. Daley told a news conference that he is particularly concerned that stem cell science in its infancy is ‘fertile ground for exploitation’ because so little is yet understood but the therapeutic potential is so great and ‘patients who are desperate will misunderstand the amount of progress in the field’ and become vulnerable to ‘snake oil’ ‘medical fraud’. ‘We need to be strong in condemning this kind of medical tourism’, agreed Olle Lindvall, committee co-chair and neurologist at the University of Lund in Sweden.
The guidelines will provide criteria for the characterisation and production of stem cells eventually intended for human transplantation as well as the level of evidence that should be required through lab and animal studies before conducting human clinical trials. While the guidelines are not legally binding, the members hope they will serve as regulatory guideposts for countries to translate into laws that protect patients from being swindled or harmed.
The only proven stem cell therapies are for blood disorders, certain cancers and rare immune deficiencies. Yet, a proliferation of internet websites offer costly stem-cell nostrums as cure-alls for conditions ranging from Parkinson’s disease, stroke and paralysis to anti-ageing treatments available in countries including China, Thailand and Costa Rica which Daley dismisses as ‘snake oil’. None of these therapies are scientifically proven to be safe and effective, according to Lindvall.
The numbers of individuals travelling for stem cell treatment is unknown but a team led by Timothy Caulfield at the University of Alberta ‘s Health Law Institute in Canada, surveyed 32 websites offering treatments – identified from the media and Google searches – and found that only one site described the procedure as experimental and 26 sites advertised it as being routine. Only four websites referred to peer-reviewed studies. Additionally, the treatments are expensive – 13 sites detailed prices and the average cost for a course of treatment is over INR 360,000 but if combined with cosmetic and lifestyle procedures offered then the figure increases to roughly INR 10,80,000. Insoo Hyun, a bioethicist at Case Western Reserve University in Ohio and co-chair of the committee agrees that a ‘strong statement’ is required and the wording of the draft in progress reflects this: ‘The ISSCR condemns the administration of stem cells or their direct derivatives to… patients as unproven medical innovation outside of a clinical trial, particularly when patients in these circumstances are charged for advertised medical services’. It is questionable whether these guidelines will really deter desperate individuals. Many advocacy groups offer patient guidelines and most countries, developing or otherwise, already have regulations for allowing research to enter clinical trials (albeit with varied levels of enforcement). However, most of these rules are non-specific and were created before stem cell treatments entered the limelight.