{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,5]],"date-time":"2026-10-05T17:02:57Z","timestamp":1791219777478,"version":"4.1.0"},"reference-count":41,"publisher":"Elsevier BV","license":[{"start":{"date-parts":[[2015,3,1]],"date-time":"2015-03-01T00:00:00Z","timestamp":1425168000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"}],"content-domain":{"domain":["elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Advanced Drug Delivery Reviews"],"published-print":{"date-parts":[[2015,3]]},"DOI":"10.1016\/j.addr.2014.11.009","type":"journal-article","created":{"date-parts":[[2014,11,17]],"date-time":"2014-11-17T03:35:43Z","timestamp":1416195343000},"page":"181-191","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":62,"special_numbering":"C","title":["Regulatory challenges for autologous tissue engineered products on their way from bench to bedside in Europe"],"prefix":"10.1016","volume":"82-83","author":[{"given":"Gouya","family":"Ram-Liebig","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juergen","family":"Bednarz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Burkard","family":"Stuerzebecher","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dirk","family":"Fahlenkamp","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guido","family":"Barbagli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giuseppe","family":"Romano","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ulf","family":"Balsmeyer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria-Elsa","family":"Spiegeler","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Soeren","family":"Liebig","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helmut","family":"Knispel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.addr.2014.11.009_bb0005","first-page":"121","article-title":"Regulation (EC) No 1394\/2007 of the European Parliament and of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001\/83\/EC and Regulation (EC) No 726\/2004","volume":"L 324","year":"10122007","journal-title":"Off. J. Eur. Union"},{"issue":"3","key":"10.1016\/j.addr.2014.11.009_bb0010","article-title":"Commission Directive 2009\/120\/EC of 14 September 2009 amending Directive 2001\/83\/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products","volume":"L 242","year":"2009","journal-title":"Off. J. Eur. Union"},{"key":"10.1016\/j.addr.2014.11.009_bb0015","doi-asserted-by":"crossref","first-page":"1580","DOI":"10.1016\/j.eururo.2007.08.051","article-title":"Tissue engineering for the lower urinary tract: a review of a state of the art approach","volume":"52","author":"Sievert","year":"2007","journal-title":"Eur. Urol."},{"issue":"27","key":"10.1016\/j.addr.2014.11.009_bb0020","doi-asserted-by":"crossref","first-page":"17","DOI":"10.22203\/eCM.v027sa04","article-title":"Barriers and strategies for the clinical translation of advanced orthopaedic tissue engineering protocols","volume":"6","author":"Madry","year":"2014","journal-title":"European Cell Mater."},{"key":"10.1016\/j.addr.2014.11.009_bb0025","unstructured":"Procedural advice on the provision of scientific recommendation on classification of advanced therapy medicinal products in accordance with article 17 of regulation (EC) No 1394\/2007 (online available at www.ema.europe.eu)"},{"key":"10.1016\/j.addr.2014.11.009_bb0030","unstructured":"Article 28(2) of the ATMP Regulation which, in turn, amended Article 3 of Directive 2001\/83."},{"key":"10.1016\/j.addr.2014.11.009_bb0035","unstructured":"Guideline on the risk-based approach according to Annex I, part IV of Directive 2001\/83\/EC applied to Advanced Therapy Medicinal Products. EMA\/CAT\/CPWP\/686637\/2011 (online available at www.ema.europa.eu)"},{"issue":"9520","key":"10.1016\/j.addr.2014.11.009_bb0040","doi-asserted-by":"crossref","first-page":"1379","DOI":"10.1016\/S0140-6736(06)68592-9","article-title":"Management of urethral strictures","volume":"367","author":"Waxman","year":"2006","journal-title":"Lancet"},{"issue":"13","key":"10.1016\/j.addr.2014.11.009_bb0045","first-page":"220","article-title":"Urethral stricture: etiology, investigation and treatments","volume":"110","author":"Tritschler","year":"2013","journal-title":"Dtsch. Arztl. Int."},{"issue":"3","key":"10.1016\/j.addr.2014.11.009_bb0050","doi-asserted-by":"crossref","first-page":"662","DOI":"10.1016\/S0022-5347(17)37340-8","article-title":"The buccal mucosal graft for urethral reconstruction: a preliminary report","volume":"147","author":"Burger","year":"1992","journal-title":"J. Urol."},{"issue":"3","key":"10.1016\/j.addr.2014.11.009_bb0055","doi-asserted-by":"crossref","first-page":"955","DOI":"10.1097\/01.ju.0000169422.46721.d7","article-title":"Bulbar urethroplasty using buccal mucosa grafts placed on the ventral, dorsal or lateral surface of the urethra: are results affected by the surgical technique?","volume":"174","author":"Barbagli","year":"2005","journal-title":"J. Urol."},{"issue":"2","key":"10.1016\/j.addr.2014.11.009_bb0060","doi-asserted-by":"crossref","first-page":"387","DOI":"10.1016\/j.juro.2007.03.094","article-title":"The oral mucosa graft: a systematic review","volume":"178","author":"Markiewicz","year":"2007","journal-title":"J. Urol."},{"issue":"6","key":"10.1016\/j.addr.2014.11.009_bb0065","doi-asserted-by":"crossref","first-page":"2466","DOI":"10.1016\/j.juro.2007.08.010","article-title":"Dorsal onlay buccal mucosa versus penile skin flap urethroplasty for anterior urethral strictures: results from a randomized prospective trial","volume":"178","author":"Dubey","year":"2007","journal-title":"J. Urol."},{"issue":"6","key":"10.1016\/j.addr.2014.11.009_bb0070","doi-asserted-by":"crossref","first-page":"867","DOI":"10.1111\/j.1464-410X.2004.05048.x","article-title":"Oral complications after buccal mucosal graft harvest for urethroplasty","volume":"94","author":"Dublin","year":"2004","journal-title":"BJU Int."},{"issue":"5","key":"10.1016\/j.addr.2014.11.009_bb0075","doi-asserted-by":"crossref","first-page":"1004","DOI":"10.1016\/S0090-4295(02)02523-2","article-title":"Ventral onlay urethroplasty using buccal mucosa for complex stricture repair","volume":"61","author":"Heinke","year":"2003","journal-title":"Urology"},{"issue":"1","key":"10.1016\/j.addr.2014.11.009_bb0080","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1016\/j.urology.2006.09.069","article-title":"Outcome of buccal mucosal graft urethroplasty for long and repeated stricture repair","volume":"69","author":"Mehrsai","year":"2007","journal-title":"Urology"},{"issue":"5","key":"10.1016\/j.addr.2014.11.009_bb0085","doi-asserted-by":"crossref","first-page":"1008","DOI":"10.1016\/S0090-4295(02)02585-2","article-title":"Buccal mucosa urethroplasty in the treatment of bulbar urethral strictures","volume":"61","author":"Pansadoro","year":"2003","journal-title":"Urology"},{"issue":"2","key":"10.1016\/j.addr.2014.11.009_bb0090","doi-asserted-by":"crossref","first-page":"580","DOI":"10.1097\/01.ju.0000132846.01144.9f","article-title":"The morbidity of buccal mucosal graft harvest for urethroplasty and the effect of nonclosure of the graft harvest site on postoperative pain","volume":"172","author":"Wood","year":"2004","journal-title":"J. Urol."},{"key":"10.1016\/j.addr.2014.11.009_bb0095","series-title":"Urethral Reconstructive Surgery","first-page":"213","article-title":"Complications of urethroplasty","author":"Al-Qudah","year":"2008"},{"key":"10.1016\/j.addr.2014.11.009_bb0100","unstructured":"Directive 2004\/23\/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells."},{"key":"10.1016\/j.addr.2014.11.009_bb0105","unstructured":"Commission Directive 2006\/17\/EC of 8 February 2006 implementing Directive 2004\/23\/EC of the European Parliament and of the Council as regards certain technical requirements for the donation, procurement and testing of human tissues and cells. Official J EU 2006\/L 38\/40"},{"key":"10.1016\/j.addr.2014.11.009_bb0110","series-title":"Guideline on Human Cell-based Medicinal Products","year":"2006"},{"issue":"Pt 1","key":"10.1016\/j.addr.2014.11.009_bb0115","doi-asserted-by":"crossref","first-page":"35","DOI":"10.1042\/BA20030163","article-title":"Regulatory and microbiological safety issues surrounding cell and tissue-engineering products","volume":"40","author":"Galbraith","year":"2004","journal-title":"Biotechnol. Appl. Biochem."},{"key":"10.1016\/j.addr.2014.11.009_bb0120","unstructured":"EMEA\/CHMP Points to consider on Xenogeneic Cell Therapy Medicinal Products (CPMP\/1199\/02)."},{"key":"10.1016\/j.addr.2014.11.009_bb0125","unstructured":"Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products. EMA\/410\/01 rev.3. Official J EU 2011\/C 73\/01."},{"key":"10.1016\/j.addr.2014.11.009_bb0130","author":"Guideline on the use of porcine trypsin used in the manufacture of human biological medicinal products","year":"2011"},{"key":"10.1016\/j.addr.2014.11.009_bb0135","unstructured":"EN\/ISO 10993-18:2005 Biological evaluation of medical devices- Part 18: Chemical characterization of materials."},{"key":"10.1016\/j.addr.2014.11.009_bb0140","unstructured":"EN\/ISO 10993-19:2006 Biological evaluation of medical devices- Part 19: Physico-chemical, morphological and topographical characterization of materials."},{"key":"10.1016\/j.addr.2014.11.009_bb0145","first-page":"1","article-title":"Council Directive 93\/42\/EEC of 14 June 1993 concerning medical devices","volume":"L 169","year":"1993","journal-title":"Off. J. Eur. Union"},{"key":"10.1016\/j.addr.2014.11.009_bb0150","first-page":"17","article-title":"Council Directive 90\/385\/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices","volume":"L 189","year":"1990","journal-title":"Off. J. Eur. Union"},{"key":"10.1016\/j.addr.2014.11.009_bb0155","first-page":"67","article-title":"Directive 2001\/83\/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use","volume":"L 311","year":"2001","journal-title":"Off. J. Eur. Union"},{"key":"10.1016\/j.addr.2014.11.009_bb0160","author":"Guideline on Potency Testing of Cell Based Immunotherapy Medicinal Products for the Treatment of Cancer","year":"2006"},{"key":"10.1016\/j.addr.2014.11.009_bb0165","series-title":"Guidance for Industry. Potency Tests for Cellular and Gene Therapy Products","year":"2011"},{"issue":"1","key":"10.1016\/j.addr.2014.11.009_bb0170","article-title":"Guidelines of 5 November 2013 on good distribution practice of medicinal products for human use","volume":"C 343","year":"2013","journal-title":"Off. J. Eur. Union"},{"issue":"2 Pt 1","key":"10.1016\/j.addr.2014.11.009_bb0175","doi-asserted-by":"crossref","first-page":"859","DOI":"10.1097\/01.ju.0000108383.18165.f5","article-title":"Comprehensive evaluation of ureteral healing after electrosurgical endopyelotomy in a porcine model: original report and review of the literature","volume":"171","author":"Andreoni","year":"2004","journal-title":"J. Urol."},{"issue":"5 Pt 1","key":"10.1016\/j.addr.2014.11.009_bb0180","doi-asserted-by":"crossref","first-page":"2077","DOI":"10.1097\/01.ju.0000138085.19352.b5","article-title":"Pig kidney: anatomical relationships between the intrarenal arteries and the kidney collecting system. Applied study for urological research and surgical training","volume":"172","author":"Pereira-Sampaio","year":"2004","journal-title":"J. Urol."},{"issue":"1","key":"10.1016\/j.addr.2014.11.009_bb0185","doi-asserted-by":"crossref","first-page":"145","DOI":"10.1089\/end.2007.9861","article-title":"Comparison of healing after cystotomy and repair with fibrin glue and sutured closure in the porcine model","volume":"22","author":"Borin","year":"2008","journal-title":"J. Endourol."},{"key":"10.1016\/j.addr.2014.11.009_bb0190","unstructured":"Guideline on risk management systems for medicinal products for human use (EMEA\/CHMP\/96268\/2005 of 14 November 2005"},{"issue":"5","key":"10.1016\/j.addr.2014.11.009_bb0195","doi-asserted-by":"crossref","first-page":"594","DOI":"10.1590\/S1677-55382008000500008","article-title":"Complications following urethral reconstructive surgery: a six year experience","volume":"34","author":"Navai","year":"2008","journal-title":"Int. Braz. J. Urol."},{"issue":"8","key":"10.1016\/j.addr.2014.11.009_bb0200","doi-asserted-by":"crossref","first-page":"999","DOI":"10.3727\/096368910X515854","article-title":"Evaluation of tumorigenic risk of tissue-engineered oral mucosal epithelial cells by using combinational examinations","volume":"19","author":"Thepot","year":"2010","journal-title":"Cell Transplant."},{"key":"10.1016\/j.addr.2014.11.009_bb0205","doi-asserted-by":"crossref","first-page":"936546","DOI":"10.1155\/2011\/936546","article-title":"Assessment of transformed properties in vitro and of tumorigenicity in vivo in primary keratinocytes cultured for epidermal sheet transplantation","volume":"2011","author":"Thepot","year":"2011","journal-title":"J. Skin Cancer"}],"container-title":["Advanced Drug Delivery Reviews"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0169409X14002725?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0169409X14002725?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2024,6,5]],"date-time":"2024-06-05T03:18:33Z","timestamp":1717557513000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0169409X14002725"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,3]]},"references-count":41,"alternative-id":["S0169409X14002725"],"URL":"https:\/\/doi.org\/10.1016\/j.addr.2014.11.009","relation":{},"ISSN":["0169-409X"],"issn-type":[{"value":"0169-409X","type":"print"}],"subject":[],"published":{"date-parts":[[2015,3]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Regulatory challenges for autologous tissue engineered products on their way from bench to bedside in Europe","name":"articletitle","label":"Article Title"},{"value":"Advanced Drug Delivery Reviews","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.addr.2014.11.009","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"Copyright \u00a9 2014 Elsevier B.V. All rights reserved.","name":"copyright","label":"Copyright"}]}}