Regulating Cell-Based Regenerative Medicine: The Challenges Ahead

Abstract

Those working in the regenerative medicine field currently face numerous regulatory and related challenges. This Perspective captures some of the key ideas of a UK-based working group drawn from academic, clinical and industrial communities and also identifies some key steps that should be taken in the UK and elsewhere to address these challenges.

KEYWORDSs::

• evaluation
• harmonization
• regulation
• trial protocol

Disclaimer

The views expressed here are those of the authors alone and cannot be regarded as reflecting the position of the various bodies that participated in and supported the MHRA Working Group, which the authors are members of.

Financial & competing interests disclosure

AP Hollander is cofounder of Azellon Cell Therapeutics Ltd (Manchester, UK) and he is a paid Director and Chief Scientific Officer of the company. P Kemp is founder and Director of Intercytex Ltd (Manchester, UK) and serves as Chief Executive Officer and Chief Scientific Officer. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.