This project focuses on the therapeutic use of autologous stem cells (stem cells derived from the patient’s own body) in Australia.
This project is situated within broader international interest in the regulation and ethics of innovative stem cell therapies and answers the critical policy question: How should Australia regulate the increasing use of autologous adult stem cell therapies in the absence of clear evidence of their safety and effectiveness?
Despite limited evidence of their efficacy and safety, autologous adult stem cells (ASCs) are increasingly being recommended for the treatment of chronic diseases in Australia. An increasing number of private clinics offer ASCs to patients for conditions that range from osteoarthritis to multiple sclerosis, motor neurone disease, autism and asthma. These ASCs are ‘innovative’ therapies - that is, they are therapies that are offered outside the context of formal clinical trials without clear clinical trial evidence of safety and efficacy.
This project aims to develop an ethical and regulatory framework that can provide adequate protections for vulnerable patients without impinging excessively on the clinical freedom of practitioners who wish to innovate ‘responsibly’ with stem cell products and patients who want to be part of such innovation.