Autologous stem cell therapies in Australia
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This project focuses on the therapeutic use of autologous stem cells (stem cells derived from the patient’s own body) in Australia. It 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, and an increasing number of private clinics offer ASCs to patients for indications 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.
Associate Professor Megan Munsie (Co-Investigator)
Professor Cameron Stewart (Lead Investigator), Pro Dean at Sydney Law School, a member of Sydney Health Law and an associate of the Centre for Values, Ethics and the Law in Medicine, Sydney Medical School.
Professor Ian Kerridge, Professor of Bioethics and Medicine at VELiM and Haematologist/Bone Marrow Transplant Physician at Royal North Shore Hospital, Sydney
Professor Catherine Waldby, Director, Research School of Social Sciences, Australian National University, College of Arts & Social Sciences; Visiting Professor at the Department of Social Science and Medicine at King’s College London
Dr Wendy Lipworth, Senior Research Fellow and NHMRC Career Development Fellow at the Centre for Values, Ethics and the Law in Medicine, The University of Sydney
Dr Tamra Lysaght Assistant Professor at the Centre for Biomedical, National University of Singapore
Dr Tereza Hendl, Postdoctoral fellow, Centre for Values, Ethics and Law in Medicine (VELiM) at the University of Sydney.
Australian Research Council Linkage Project
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