TY - JOUR
T1 - The evolving regulatory landscape in regenerative medicine
AU - Beetler, Danielle J.
AU - Di Florio, Damian N.
AU - Law, Ethan W.
AU - Groen, Chris M.
AU - Windebank, Anthony J.
AU - Peterson, Quinn P.
AU - Fairweather, De Lisa
N1 - Publisher Copyright:
© 2022 The Authors
PY - 2023/6
Y1 - 2023/6
N2 - Regenerative medicine as a field has emerged as a new component of modern medicine and medical research that encompasses a wide range of products including cellular and acellular therapies. As this new field emerged, regulatory agencies like the Food and Drug Administration (FDA) rapidly adapted existing regulatory frameworks to address the transplantation, gene therapy, cell-based therapeutics, and acellular biologics that fall under the broader regenerative medicine umbrella. Where it has not been possible to modify existing regulation and processes, entirely new frameworks have been generated with the intention of providing flexible, forward-facing systems to regulate this rapidly growing field. This review discusses the current state of FDA regulatory affairs in the context of stem cells and extracellular vesicles by highlighting gaps in the current regulatory system and then discussing where regulatory science in regenerative medicine may be headed based on these gaps and the FDA's historical ability to deal with emerging fields. Lastly, we utilize case studies in stem cell and acellular based treatments to demonstrate how regulatory science has evolved in regenerative medicine and highlight the ongoing clinical efforts and challenges of these therapies.
AB - Regenerative medicine as a field has emerged as a new component of modern medicine and medical research that encompasses a wide range of products including cellular and acellular therapies. As this new field emerged, regulatory agencies like the Food and Drug Administration (FDA) rapidly adapted existing regulatory frameworks to address the transplantation, gene therapy, cell-based therapeutics, and acellular biologics that fall under the broader regenerative medicine umbrella. Where it has not been possible to modify existing regulation and processes, entirely new frameworks have been generated with the intention of providing flexible, forward-facing systems to regulate this rapidly growing field. This review discusses the current state of FDA regulatory affairs in the context of stem cells and extracellular vesicles by highlighting gaps in the current regulatory system and then discussing where regulatory science in regenerative medicine may be headed based on these gaps and the FDA's historical ability to deal with emerging fields. Lastly, we utilize case studies in stem cell and acellular based treatments to demonstrate how regulatory science has evolved in regenerative medicine and highlight the ongoing clinical efforts and challenges of these therapies.
KW - Extracellular vesicles
KW - Nanomedicine
KW - Regenerative medicine
KW - Stem cells
KW - Translational research
UR - http://www.scopus.com/inward/record.url?scp=85137288892&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85137288892&partnerID=8YFLogxK
U2 - 10.1016/j.mam.2022.101138
DO - 10.1016/j.mam.2022.101138
M3 - Review article
C2 - 36050142
AN - SCOPUS:85137288892
SN - 0098-2997
VL - 91
JO - Molecular Aspects of Medicine
JF - Molecular Aspects of Medicine
M1 - 101138
ER -