Journal
ADVANCED DRUG DELIVERY REVIEWS
Volume 82-83, Issue -, Pages 181-191Publisher
ELSEVIER
DOI: 10.1016/j.addr.2014.11.009
Keywords
Tissue-engineering; Urethral stricture; ATMP; Regulation; Oral mucosa graft
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Funding
- UroTiss GmbH
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Since the late eighties of last century the high potential of tissue engineered products (TEP)s has been shown for the treatment of various diseases and many scientific publications appeared in this field. However, only few products reached the market since. Development of TEPs is a promising but owing to its novelty a very challenging task that requires experts in this still developing field as well as ample financial resources. This paper summarises relevant regulatory challenges during quality, preclinical and clinical development of autologous TEPs in Europe. Selected strategies on how to manage major issues are presented, together with some examples from the development of an autologous TEP for urethroplasty. Considering these aspects may help other investigators with potential strategies during the development of novel TEPs. (C) 2014 Elsevier B.V. All rights reserved.
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