Regulating the Stem Cell Industry: Needs and Responsibilities

Abstract

Emerging biotechnologies pose public health challenges1 because of both the known and unforeseen risks they carry, the uncertain medical benefits they offer, the speed at which they have disseminated and their unproven mode of application.2 The development of therapies from advances in stem cell science reveals the need to pay critical attention to stem cell treatments. Stem cells have attracted scientific, clinical and public interest because they are self-renewing and have the capacity to develop into specific cell types, depending on the source of stem cells and their biological plasticity. The hope is that stem cells could be used either to replace damaged cells or to create an environment for cellular regeneration to treat several conditions, including osteoarthritis, diabetes, macular degeneration and Parkinson disease. Although promising in theory, so far very few stem cell therapies have proven to be safe and effective in clinical trials. Yet, despite the absence of evidence to support their use, there has been a global proliferation of clinics and associated businesses offering stem cell-based interventions to patients having serious medical conditions.3 These clinics operate mostly in the private health-care sector and typically market their interventions directly to patients over the Internet. The emergence of these clinics has not only created domestic markets in many highincome countries,3 but has also fomented stem cell tourism – the movement of people across international boundaries to access putative stem cell treatments. The global reach of this expanding industry exploits weaknesses and differences in national regulatory infrastructures4 and has revealed the need for an international approach to report and monitor the harms and benefits of these putative treatments.