The International Society for Stem Cell Research (ISSCR) has this week warned patients against unproven stem cell treatments being offered by rogue clinicians. The calls were made to governments to tighten their regulatory regimes to crack down on those exploiting the vulnerable with claims of revolutionary stem cell-based treatments that are not substantiated by peer reviewed publications and that carry significant potential for harm.
The ISSCR organised a task force of thirty academics and clinicians from thirteen countries to produce the guidelines, which they claim have been formulated with the participation of 'key international stakeholders' in stem cell research and development. Insoo Hyun, associate professor of bioethics at Case Western Reserve University School of Medicine in Cleveland, US, the lead author of a paper in the journal Cell: Stem Cell, introduced the guidelines. He told the Washington Post that: 'legitimate science is speeding ahead and getting to the point where there needed to be more of a road map to take the basic knowledge to clinical applications' - the problem in the short term being those attempting to profit from the hope generated by these rapid successes.
The proliferation of adverts online for dubious clinics offering ambiguous stem cell therapies at prices rising to the tens of thousands of pounds were taken as evidence that there is an urgent need for international standards to be drawn up. Specifically targeted are the minimally regulated regimes in Central and South America, the Far East and India where most of these adverts lead. George Daley, of the Boston Children's Hospital, and one of the contributors to the guidelines, told the Times: 'I think these websites are dangerous. They overpromise effectiveness and safety of the therapy and under inform about risks. Overhyped marketing direct to patients is putting patients at risk of financial exploitation at the very least, and physical danger at the worst.'
Alongside the guidelines, aimed at governmental regulators, a patient information booklet was also released containing questions that patients should pose to clinicians when being offered novel or experimental therapies and warning them against clinics claiming to treat multiple conditions with a single therapy. (The guide is available to download at http://tinyurl.com/ISSCR.) The guidelines note that though there is sometimes a place for unproven treatments to be used outside of a clinical trial, that these occasions are rare.
However one of the co-chairs of the task force, Olle Lindvall, Professor of Neurology at Lund University, Sweden, has already expressed concerns that the guidelines may have little effect on those clinics operating outside of the scientific mainstream. In an interview with Nature he noted that 'more of the clinics are interested in making money than in helping patients' and that it was simply hoped that the formation of international consensus might lead countries to crack down on rogue practitioners.