In 2016, the Office of the State Coroner of New South Wales released its report into the death of an Australian woman, Sheila Drysdale, who had died from complications of an autologous stem cell procedure at a Sydney clinic. In this report, we argue that Mrs Drysdale's death was avoidable, and it was the result of a pernicious global problem of an industry exploiting regulatory systems to sell unproven and unjustified interventions with stem cells.

Regulators around the world are coming under pressure from patients, clinicians, and industry groups to streamline the market approval process for highly novel biomedical technologies, including stem cells and regenerative medicine products. The rationale for streamlining this process centers on the perceived failures of regulatory systems to encourage biomedical innovation and provide patients with timely access to potentially beneficial yet experimental therapies. Critics claim that the process of generating scientific evidence in phased clinical trials is too costly, time-consuming, and poorly (...) suited for stem cell–based products that, unlike bio-pharmaceuticals, are intended to engraft into the body for long... (shrink)