Document Detail


Autologous cell therapies: challenges in US FDA regulation.
MedLine Citation:
PMID:  23210819     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
Cell-based therapies (CBTs) have been hailed for the last two decades as the next pillar of healthcare, yet the clinical and commercial potential of regenerative medicine has yet to live up to the hype. While recent analysis has suggested that regenerative medicine is maturing into a multibillion dollar industry, examples of clinical and commercial success are still relatively rare [1-3] . With 30 years of laboratory and clinical efforts fueled by countless billions in public and private funding, one must contemplate why CBTs have not made a greater impact. The current regulatory environment, with its zero-risk stance, stymies clinical innovation while fueling a potentially risky medical tourism industry. Here, we highlight the challenges the US FDA faces and present talking points for an improved regulatory framework for autologous CBTs.
Authors:
Todd N McAllister; David Audley; Nicolas L'heureux
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Regenerative medicine     Volume:  7     ISSN:  1746-076X     ISO Abbreviation:  Regen Med     Publication Date:  2012 Nov 
Date Detail:
Created Date:  2012-12-05     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101278116     Medline TA:  Regen Med     Country:  England    
Other Details:
Languages:  eng     Pagination:  94-7     Citation Subset:  IM    
Affiliation:
Cytograft Tissue Engineering, Inc., 3 Hamilton Landing, Suite 220, Novato, CA 94949, USA.
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