Global bionetworks and challenges in regulating autologous adult stem cells

Abstract

Autologous adult stem cells (ASCs) are increasingly being administered to patients with limited evidence from clinical trials that they are safe and effective. The marketing of autologous ASCs predominantly over the Internet by companies based in low-to-middle income countries, such as the Bahamas, Mexico, India and China, is well documented.(1, 2) However, even in countries such as the United States, Japan, and Australia, physicians are prescribing autologous ASCs to patients outside the context of clinical trials. These doctors often form part of loose collaborative networks of clinicians, businesses, patients and researchers operating both domestically and across national boundaries. The emergence of these networks not only puts patients who seek out these interventions at risk: it threatens to undermine the very basis of ‘good medical practice’.