title: Regulatory challenges for autologous tissue engineered products on their way from bench to bedside in Europe.
abstract: 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.
authors.affiliation: UroTiss GmbH, Dresden, Germany. Electronic address: g.ram-liebig@urotiss.com.
authors.forename: Gouya
authors.initials: G
authors.lastname: Ram-Liebig
authors.affiliation: UroTiss GmbH, Dresden, Germany.
authors.forename: Juergen
authors.initials: J
authors.lastname: Bednarz
authors.affiliation: St. Hedwig Hospital, Department of Urology, Berlin, Germany.
authors.forename: Burkard
authors.initials: B
authors.lastname: Stuerzebecher
authors.affiliation: Zeisigwald Clinics Bethanien, Department of Urology, Chemnitz, Germany.
authors.forename: Dirk
authors.initials: D
authors.lastname: Fahlenkamp
authors.affiliation: Centro Chirurgico Toscana, Arezzo, Italy.
authors.forename: Guido
authors.initials: G
authors.lastname: Barbagli
authors.affiliation: Urology Unit, Ospedale del Valdarno, Santa Maria alla Gruccia, Montevarchi-Arezzo, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Romano
authors.affiliation: Zeisigwald Clinics Bethanien, Department of Urology, Chemnitz, Germany.
authors.forename: Ulf
authors.initials: U
authors.lastname: Balsmeyer
authors.affiliation: St. Hedwig Hospital, Department of Urology, Berlin, Germany.
authors.forename: Maria-Elsa
authors.initials: ME
authors.lastname: Spiegeler
authors.affiliation: UroTiss GmbH, Dresden, Germany.
authors.forename: Soeren
authors.initials: S
authors.lastname: Liebig
authors.affiliation: St. Hedwig Hospital, Department of Urology, Berlin, Germany.
authors.forename: Helmut
authors.initials: H
authors.lastname: Knispel
mesh_terms: D000818:Animals; D005060:Europe; D006801:Humans; D023822:Tissue Engineering / Q000331:legislation & jurisprudence*; D057170:Translational Research, Biomedical / Q000331:legislation & jurisprudence*; D014182:Transplantation, Autologous / Q000331:legislation & jurisprudence*
keywords: ATMP; Oral mucosa graft; Regulation; Tissue-engineering; Urethral stricture