Regulating Clinical Uses of Autologous Adult Stem Cells: An International Review

Guest Speaker:
Dr Tamra Lysaght (Centre for Biomedical Ethics, Yong Loo Lin School of Medicine, National University of Singapore)
Dr Wee Kiat Ong (School of Pharmacy, University of Reading Malaysia)
Subject Area:
Date & Time:
Wed, 2. November 2016, 14:00 h - 15:00 h
N3.23, University of Reading Malaysia - EduCity@Iskandar​

Autologous adult stem cells (ASCs) are increasingly being offered to patients for a range of chronic and debilitating diseases despite the fact that there is limited peer reviewed scientific evidence to support the majority of these clinical applications outside of bone marrow transplantation. For the most part, these interventions are offered as 'innovative' or 'experimental' therapies in private medical clinics, and have been observed in lower to middle income countries, such as China, India and Mexico, as well as higher income countries Japan, the United States, Germany and Australia. They raise serious concerns over the safety and welfare of vulnerable patient populations, the regulation of novel cell-based therapeutics, and the governance of medical professionals. In this paper, I review the regulatory mechanisms that oversee the clinical use of autologous ASCs in Australia, Japan, Singapore, South Korea, the United Kingdom and United States, to identify weaknesses that may be encouraging these practices. I discuss the challenges that regulators face in controlling these practices and make suggestions for new models of governance to oversee the clinical translation of ASCs.

Dr Lysaght is an Assistant Professor at the Centre for Biomedical Ethics at the National University of Singapore. Her research interests lie broadly in the ethical, sociopolitical and regulatory issues surrounding stem cell science and the clinical translation of regenerative medicines and genomics. She has expertise is in empirical ethics and experience in using both qualitative and quantitative research methods, and has worked on policy issues with the Ethics Committee of the Human Genome Organisation, the Technical Working Group on Ethics at the World Health Organization and the Translational Clinical Research Programme of the Institute of Mental Health in Singapore, and the Human Health Division of the International Atomic Energy Agency. She is currently working on the ethics and regulation of cell therapies and translational medicine in Asia and Australasia.

  • Admission is free.​
  • Tea break will be served at 3:00 pm.
  • UoRM staff RSVP by responding to the internal event invitation.
  • All are welcome, RSVP by 28 October 2016.

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