A roundtable on responsible innovation with autologous stem cells in Australia, Japan and Singapore.

Autor: Lysaght T; Centre for Biomedical Ethics, National University of Singapore, Singapore. Electronic address: tlysaght@nus.edu.sg., Munsie M; Centre for Stem Cell Systems, University of Melbourne, Melbourne, Australia., Castricum A; Australasian College of Sports and Exercise Physicians, Melbourne., Hui JHP; National University Health System, Singapore., Okada K; Osaka University Graduate School of Medicine, Osaka., Sato Y; National Institute of Health Sciences, Japan, Osaka., Sawa Y; Osaka University Graduate School of Medicine, Osaka., Stewart C; Sydney Law School, University of Sydney, Sydney, Australia., Tan LK; National University Health System, Singapore., Tan LHY; Centre for Biomedical Ethics, National University of Singapore, Singapore., Sugii S; Singapore Bioimaging Consortium, A*STAR, and Duke-NUS Medical School, Singapore.
Jazyk: angličtina
Zdroj: Cytotherapy [Cytotherapy] 2018 Sep; Vol. 20 (9), pp. 1103-1109. Date of Electronic Publication: 2018 Aug 19.
DOI: 10.1016/j.jcyt.2018.06.004
Abstrakt: We report on a roundtable event hosted in Singapore that sought to identify some of the ethical and regulatory challenges in translating autologous cell-based interventions, particularly those claiming to involve stem cells, into safe and effective therapies and to propose some solutions to encourage responsible innovation with these products. Challenges are identified in the three areas of cell manufacturing and processing, innovative uses of autologous cells in clinical practice and standards of evidence. Proposed solutions are discussed within a co-operative model of statutory laws and regulations that can enable product development with autologous cells and professional codes and standards that can encourage ethical conduct in clinical practice. Future research should be directed toward establishing regional networks for the development of internationally consistent standards in manufacturing and ethical codes of conduct for innovating with stem cells, and other autologous cells, and fostering ongoing exchange between jurisdictions.
(Copyright © 2018 Elsevier Ltd. All rights reserved.)
Databáze: MEDLINE
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