The need for responsible innovation: Autologous stem cell “therapies” in Australia

Tereza Hendl1, Cameron Stewart 2, Megan Munsie3, Ian Kerridge4

1 Centre for Values, Ethics and the Law in Medicine, Medical Foundation Building, University of Sydney, NSW, 2006, Australia, Tereza.hendl@sydney.edu.au
2 Sydney Law School, New Law Building, University of Sydney, NSW, 2006, Australia, cameron.stewart@sydney.edu.au
3 Stem Cells Australia, Level 2 Kenneth Myer Building, The University of Melbourne, 30 Royal Parade, Parkville VIC 3010, megan.munsie@unimelb.edu.au
4 Centre for Values, Ethics and the Law in Medicine, Medical Foundation Building, University of Sydney, NSW, 2006, Australia, ian.kerridge@sydney.edu.au

Autologous stem cells (ASCs, stem cells derived from the patient’s own body) have an established role in blood and marrow transplantation (BMT) for a range of conditions affecting adults and children. Increasingly, however, ASC therapies are being promoted for the treatment of chronic diseases, with a growing number of private clinics offering ASCs to patients of all ages for a range of conditions including osteoarthritis, motor neurone disease, autism and asthma.

According to the information package from a Sydney-based clinic offering ASC therapy, “Stem cells are extremely versatile which makes this treatment an extremely valuable scientific medical procedure. Scientists and Doctors are discovering new ways to use Stem Cell Therapy every day”. The reality, however, is quite different. Research has been slow and incremental with few ASC therapies tested in Phase 3 trials. Given uncertainty regarding their efficacy and safety, the bold and confident claims of those selling ASCs are questionable at best. But because ASCs are being offered as “innovative” therapies outside “standard practice” and formal clinical trials, patients may not be aware of the lack of evidence supporting their use. Patient advocacy organisations, likewise, have found themselves in a difficult position with regards to ASC therapies as they are aware of the needs, rights and hopes of their members and their carers and supportive of research into the development of safe and effective therapies but are also conscious that they should protect vulnerable patients from harm. In this paper, we present an overview of the clinical practice involving ASCs in Australia and the ethical implications of existing conceptual and regulatory “loopholes” that have enabled the emergence of a flourishing ASC therapeutic “industry”. We argue that there is a pressing need to develop an ethical and socially sustainable regulatory environment for innovation of ASCs treatments in Australia.

 


Biography

Tereza Hendl is a Postdoctoral Research Fellow at the Centre for Values, Ethics and the Law in Medicine (VELiM) at the University of Sydney. She completed a PhD in Philosophy at Macquarie University with a dissertation exploring ethical aspects of sex selection for social reasons. Her paper “A Feminist Critique of Justifications for Sex Selection” was awarded the 2015 Max Charlesworth Prize in Bioethics. Dr Hendl’s research interests include global aspects of biomedical practice and issues related to gender, sexuality and disability. At VELiM she works on a project focusing on the regulation of autologous stem cell therapies in Australia.

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The Australasian Association of Bioethics and Health Law (AABHL) was formed in 2009.

It encourages open discussion and debate on a range of bioethical issues, providing a place where people can ask difficult questions about ideas and practices associated with health and illness, biomedical research and human values.

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