Long-term outcomes of a cultured autologous dermo-epidermal skin substitute in children: 5 year results of a phase I clinical trial.

Autor:	Schiestl C; Pediatric Burn Center, Children's Skin Center, Department of Surgery, University Children's Hospital Zurich, University of Zurich, Steinwiesstrasse 75, 8032 Zurich, Switzerland.; Department of Surgery, University Children's Hospital Zurich, University of Zurich, Steinwiesstrasse 75, 8032 Zurich, Switzerland.; Children's Research Center (CRC), University Children's Hospital Zurich, University of Zurich, Steinwiesstrasse 75, 8032 Zurich, Switzerland.; University of Zurich (UZH), Rämistrasse 71, 8006 Zurich, Switzerland., Neuhaus K; Pediatric Burn Center, Children's Skin Center, Department of Surgery, University Children's Hospital Zurich, University of Zurich, Steinwiesstrasse 75, 8032 Zurich, Switzerland.; Department of Surgery, University Children's Hospital Zurich, University of Zurich, Steinwiesstrasse 75, 8032 Zurich, Switzerland.; Children's Research Center (CRC), University Children's Hospital Zurich, University of Zurich, Steinwiesstrasse 75, 8032 Zurich, Switzerland.; University of Zurich (UZH), Rämistrasse 71, 8006 Zurich, Switzerland., Meuli M; University of Zurich (UZH), Rämistrasse 71, 8006 Zurich, Switzerland.; CUTISS Ltd, Grabenstrasse 11, 8952 Schlieren, Switzerland., Farkas M; Pediatric Burn Center, Children's Skin Center, Department of Surgery, University Children's Hospital Zurich, University of Zurich, Steinwiesstrasse 75, 8032 Zurich, Switzerland.; Department of Surgery, University Children's Hospital Zurich, University of Zurich, Steinwiesstrasse 75, 8032 Zurich, Switzerland.; Children's Research Center (CRC), University Children's Hospital Zurich, University of Zurich, Steinwiesstrasse 75, 8032 Zurich, Switzerland.; University of Zurich (UZH), Rämistrasse 71, 8006 Zurich, Switzerland., Hartmann-Fritsch F; University of Zurich (UZH), Rämistrasse 71, 8006 Zurich, Switzerland.; CUTISS Ltd, Grabenstrasse 11, 8952 Schlieren, Switzerland., Elrod J; Department of Pediatric Surgery, University Medical Center Mannheim, Heidelberg University, Theodor-Kutzer-Ufer 1-3, 68167 Mannheim, Germany., Bressan J; Pediatric Burn Center, Children's Skin Center, Department of Surgery, University Children's Hospital Zurich, University of Zurich, Steinwiesstrasse 75, 8032 Zurich, Switzerland.; Department of Surgery, University Children's Hospital Zurich, University of Zurich, Steinwiesstrasse 75, 8032 Zurich, Switzerland.; Children's Research Center (CRC), University Children's Hospital Zurich, University of Zurich, Steinwiesstrasse 75, 8032 Zurich, Switzerland.; University of Zurich (UZH), Rämistrasse 71, 8006 Zurich, Switzerland., Reichmann E; Children's Research Center (CRC), University Children's Hospital Zurich, University of Zurich, Steinwiesstrasse 75, 8032 Zurich, Switzerland.; University of Zurich (UZH), Rämistrasse 71, 8006 Zurich, Switzerland.; Tissue Biology Research Unit, Department of Surgery, University Children's Hospital Zurich, University of Zurich, Wagistrasse 12, 8952 Schlieren, Switzerland., Böttcher-Haberzeth S; Pediatric Burn Center, Children's Skin Center, Department of Surgery, University Children's Hospital Zurich, University of Zurich, Steinwiesstrasse 75, 8032 Zurich, Switzerland.; Department of Surgery, University Children's Hospital Zurich, University of Zurich, Steinwiesstrasse 75, 8032 Zurich, Switzerland.; Children's Research Center (CRC), University Children's Hospital Zurich, University of Zurich, Steinwiesstrasse 75, 8032 Zurich, Switzerland.; University of Zurich (UZH), Rämistrasse 71, 8006 Zurich, Switzerland.
Jazyk:	angličtina
Zdroj:	Journal of burn care & research : official publication of the American Burn Association [J Burn Care Res] 2024 Aug 08. Date of Electronic Publication: 2024 Aug 08.
DOI:	10.1093/jbcr/irae150
Abstrakt:	Limited donor sites and poor long-term outcomes with standard treatment for large skin defects remain a huge problem. An autologous, bilayered, laboratory-grown skin substitute (denovoSkin™) was developed to overcome this problem and has shown to be safe in ten pediatric patients in a phase I clinical trial after transplantation. The goal of this article is to report on 48 months long-term results. The pediatric participants of the phase I clinical trial were followed at yearly visits up to five years after transplantation. Safety parameters including occurrence of adverse events, possible deviations of vital signs and changes in concomitant therapy as well as additional parameters regarding skin stability, scar quality and tumor formation were assessed. Furthermore, scar maturation was photographically documented. From the ten patients treated with denovoSkinTM in this phase I clinical trial, seven completed the five-year follow-up period. Skin substitutes continued to be deemed safe, remained stable and practically unchanged, with no sign of fragility, and no tumor formation at clinical examination. Scar quality, captured by applying the Patient and Observer Scar Assessment Scale, was evaluated as close to normal skin. Transplantation of this laboratory-grown skin substitute in children is to date considered safe and shows encouraging functional and aesthetical long-term results close to normal skin. These results are promising and highlight the potential of a life-saving therapy for large skin defects. A multicentre, prospective, randomized phase II clinical trial to further evaluate the safety and efficacy of this novel skin substitute is currently ongoing. (© The Author(s) 2024. Published by Oxford University Press on behalf of the American Burn Association.)
Databáze:	MEDLINE
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