Human cell- and tissue- based products: Progress, promise and regulatory issues

Phil Brown
Greg Dombal
Daniel Dornbusch
Behruz Eslami
Alison Lawton
Susan Stewart
Michael Vasconcelles
Erik Tambuyzer

DOI:https://doi.org/10.5912/jcb395

Abstract:

The field of cell- and tissue-based products is radically changing through the use of biotechnology. The authors outline developments that are currently taking place, leading to the need for adapted regulations, for which worldwide harmonisation is important since potential safety issues have no borders and companies operate globally. Potential ethical issues need to be discussed and resolved within society in an open and transparent way.

Keywords:cell therapy ,ethics ,harmonisation ,safety ,worldwide regulatory framework ,en ,