Developing Ethico-Regulatory Guidance for Autologous Stem Cell Therapies in Australia.

Professor Cameron Stewart

University of Sydney

| A cure via repair and regeneration | Better treatments | Neurobiology | Other | 2015 | Investigator Led Research |
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Summary

This project focuses on the ethical and legal framework for the therapeutic use of autologous stem cells in Australia. It is not concentrating on AHSCT or autologous hematopoietic stem cell therapy, but rather on other types of proposed cell and tissue therapies in which the cells or tissues are taken from the patient (autologous) and returned to them for a therapeutic purpose.

A number of private medical clinics are offering stem cell therapies (commonly adipose derived autologous stem cells- or stem cells derived from the fat tissue in one’s own body) for a range of chronic diseases including MS. This is despite the lack of scientific evidence to support the safety or the efficacy of this treatment for these diseases.

Innovation is important in medicine and should be encouraged. However patient safety is also of paramount importance. In many cases experimental autologous stem cell therapies are offered as treatments to potentially vulnerable patients outside of the framework of ethically approved clinical trials.

Dr Cameron and his team have been awarded an Australian Research Council (ARC) Linkage Grant. Linkage grants enable industry and not-for-profit partners to co-fund with the ARC to support major academic groups to pursue projects that are of common interest and importance to all parties. This project aims to develop an ethical and regulatory framework that can provide adequate protections for patients without impinging excessively on the clinical freedom of practitioners who wish to develop innovative treatments with stem cell products and enable patients to safely be part of such innovation.

MS Research Australia is a 'not-for-profit' partner contributing funds to this ARC Linkage Grant and collaborating with the researchers to provide in-put, insight and expertise during the project.

Progress to Date

The team has been very active in gathering data on international and national examples of stem cell regulation and positions. They have also completed qualitative focus groups and interviews with health professionals, patients, carers and family members. Recruitment for further interviews of patients and families is ongoing. A major roundtable event was held in Singapore in November 2017. This event brought together scientists, clinicians, regulators, legal scholars and bioethicists from Australia, Japan and Singapore. The event resulted in a
policy brief discussing responsible innovation with autologous stem cells in Australia, Japan and Singapore. The findings of this project to date have already resulted in a significant number of publications and conference presentations that are contributing to this important field of policy development in regulation of innovations in medical interventions and technologies. During the course of the project the Australian Therapeutic Goods Administration (TGA) has been concurrently reviewing the regulations surrounding the use of autologous tissues and cells. Both this research team and MS Research Australia have contributed to the public consultation processes that have occurred during this review. Members of this research team are also now involved in consulting to the TGA as they implement and communicate the changes to the regulation.

During 2018 the team will complete the collection of data conduct analysis of this information in preparation for further publications and policy documents on the ethical and regulatory issues associated with emerging autologous cell therapies.

Updated: 10 July, 2017

Co-investigator

Grant Awarded

  • Project Grant

Total Funding

  • $60,000

  • Contribution to $450,000 ARC Linkage Grant

Duration

  • 3 years over 2015 - 2018

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