Regulatory loophole enables unproven autologous cell therapies to thrive in Australia

As in many jurisdictions around the world, there are a growing number of doctors in Australia who are offering autologous cell therapies outside of a clinical trial setting and in the absence of sound and convincing evidence of safety or efficacy. Such interventions, often marketed as "stem cell" treatments, involve the administration of the patient's own cells-or products derived from them-for a wide range of conditions at considerable financial cost to patients. At present, Australian regulations treat autologous cell treatments as medical practice, exempt from the regulatory framework for cell and gene therapy and biologicals. As a consequence, Australia risks becoming the destination of choice for those practitioners seeking to capitalize on community demand for "stem cell" therapies.