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

Abstract:

: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.

journal_name

Cytotherapy

journal_title

Cytotherapy

authors

Lysaght T,Munsie M,Castricum A,Hui JHP,Okada K,Sato Y,Sawa Y,Stewart C,Tan LK,Tan LHY,Sugii S

doi

10.1016/j.jcyt.2018.06.004

subject

Has Abstract

pub_date

2018-09-01 00:00:00

pages

1103-1109

issue

9

eissn

1465-3249

issn

1477-2566

pii

S1465-3249(18)30546-2

journal_volume

20

pub_type

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