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Clinical Trial
Engineered autologous cartilage tissue for nasal reconstruction after tumour resection: an observational first-in-human trial.
- Ilario Fulco, Sylvie Miot, Martin D Haug, Andrea Barbero, Anke Wixmerten, Sandra Feliciano, Francine Wolf, Gernot Jundt, Anna Marsano, Jian Farhadi, Michael Heberer, Marcel Jakob, Dirk J Schaefer, and Ivan Martin.
- Department of Surgery and Department of Biomedicine, University Hospital Basel, University of Basel, Basel, Switzerland.
- Lancet. 2014 Jul 26;384(9940):337-46.
BackgroundAutologous native cartilage from the nasal septum, ear, or rib is the standard material for surgical reconstruction of the nasal alar lobule after two-layer excision of non-melanoma skin cancer. We assessed whether engineered autologous cartilage grafts allow safe and functional alar lobule restoration.MethodsIn a first-in-human trial, we recruited five patients at the University Hospital Basel (Basel, Switzerland). To be eligible, patients had to be aged at least 18 years and have a two-layer defect (≥50% size of alar subunit) after excision of non-melanoma skin cancer on the alar lobule. Chondrocytes (isolated from a 6 mm cartilage biopsy sample from the nasal septum harvested under local anaesthesia during collection of tumour biopsy sample) were expanded, seeded, and cultured with autologous serum onto collagen type I and type III membranes in the course of 4 weeks. The resulting engineered cartilage grafts (25 mm × 25 mm × 2 mm) were shaped intra-operatively and implanted after tumour excision under paramedian forehead or nasolabial flaps, as in standard reconstruction with native cartilage. During flap refinement after 6 months, we took biopsy samples of repair tissues and histologically analysed them. The primary outcomes were safety and feasibility of the procedure, assessed 12 months after reconstruction. At least 1 year after implantation, when reconstruction is typically stabilised, we assessed patient satisfaction and functional outcomes (alar cutaneous sensibility, structural stability, and respiratory flow rate).FindingsBetween Dec 13, 2010, and Feb 6, 2012, we enrolled two women and three men aged 76-88 years. All engineered grafts contained a mixed hyaline and fibrous cartilage matrix. 6 months after implantation, reconstructed tissues displayed fibromuscular fatty structures typical of the alar lobule. After 1 year, all patients were satisfied with the aesthetic and functional outcomes and no adverse events had been recorded. Cutaneous sensibility and structural stability of the reconstructed area were clinically satisfactory, with adequate respiratory function.InterpretationAutologous nasal cartilage tissues can be engineered and clinically used for functional restoration of alar lobules. Engineered cartilage should now be assessed for other challenging facial reconstructions.FundingFoundation of the Department of Surgery, University Hospital Basel; and Krebsliga beider Basel.Copyright © 2014 Elsevier Ltd. All rights reserved.
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