Regulatory challenges for autologous tissue engineered products on their way from bench to bedside in Europe

Autor:	Soeren Liebig, Juergen Bednarz, Guido Barbagli, Helmut H. Knispel, Dirk Fahlenkamp, Burkard Stuerzebecher, Giuseppe Romano, Maria-Elsa Spiegeler, Gouya Ram-Liebig, Ulf Balsmeyer
Rok vydání:	2015
Předmět:	Tissue engineered Tissue Engineering business.industry Novelty Pharmaceutical Science Nanotechnology Autologous tissue Transplantation Autologous Bench to bedside Europe Translational Research Biomedical Risk analysis (engineering) Animals Humans Medicine business High potential
Zdroj:	Advanced Drug Delivery Reviews. :181-191
ISSN:	0169-409X
DOI:	10.1016/j.addr.2014.11.009
Popis:	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.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::71b5be55128f737e498a4f0057bbaca3 https://doi.org/10.1016/j.addr.2014.11.009 Zobrazit plný text záznamu Full Text from ScienceDirect