Regulating unproven stem cell interventions : how effective are the ISSCR guidelines?

There are for-profit private stem cell clinics that promote using stem cells to treat a variety of diseases and conditions. This is very enticing for some patients who pursue such treatments, including putative untested stem cell-based therapies. Some patients are even willing to travel overseas to get these so-called treatments, known as transnational stem cell tourism. While there is promising research carried out on stem cells in the laboratories, an ever-growing industry targets vulnerable patients all over the world. Alarmingly, there have been accounts of claims of miracle cures and adverse medical events, including fatalities. Accordingly, it is imperative such untested stem cell therapies are stringently regulated. Currently, there are Guidelines for Stem Cell Research and Clinical Translation issued by the International Society for Stem Cell Research (ISSCR Guidelines). This article provides a critical analysis of the guidelines. I argue that while the ISSCR Guidelines are comprehensive and exemplary, they are not entirely effective and much more efforts are required to address this serious problem.