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
Cytotherapyjournal_title
Cytotherapyauthors
Lysaght T,Munsie M,Castricum A,Hui JHP,Okada K,Sato Y,Sawa Y,Stewart C,Tan LK,Tan LHY,Sugii Sdoi
10.1016/j.jcyt.2018.06.004subject
Has Abstractpub_date
2018-09-01 00:00:00pages
1103-1109issue
9eissn
1465-3249issn
1477-2566pii
S1465-3249(18)30546-2journal_volume
20pub_type
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