Abstract

Regulating clinical uses of autologous adult stem cells: an international review

Tamra Lysaght, Assistant Professor , National University of Singapore

Autologous adult stem cells (ASCs) are increasingly being offered to patients for a range of chronic and debilitating diseases despite the fact that there is limited peer reviewed scientific evidence to support the majority of these clinical applications outside of bone marrow transplantation. For the most part, these interventions are offered as ‘innovative’ or ‘experimental’ therapies in private medical clinics, and have been observed in lower to middle income countries, such as China, India and Mexico, as well as higher income countries Japan, the United States, Germany and Australia. They raise serious concerns over the safety and welfare of vulnerable patient populations, the regulation of novel cell-based therapeutics, and the governance of medical professionals. In this paper, I review the regulatory mechanisms that oversee the clinical use of autologous ASCs in Australia, Japan, Singapore, South Korea, the United Kingdom and United States, to identify weaknesses that may be encouraging these practices. I discuss the challenges that regulators face in controlling these practices and make suggestions for new models of governance to oversee the clinical translation of ASCs.