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Status: Bibliographieeintrag

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Verfasst von:Schiestl, Clemens [VerfasserIn]   i
 Neuhaus, Kathrin [VerfasserIn]   i
 Meuli, Martin [VerfasserIn]   i
 Farkas, Melinda [VerfasserIn]   i
 Hartmann-Fritsch, Fabienne [VerfasserIn]   i
 Elrod, Julia [VerfasserIn]   i
 Bressan, Jenny [VerfasserIn]   i
 Reichmann, Ernst [VerfasserIn]   i
 Böttcher-Haberzeth, Sophie [VerfasserIn]   i
Titel:Long-term outcomes of a cultured autologous dermo-epidermal skin substitute in children
Titelzusatz:5-year results of a phase I clinical trial
Verf.angabe:Clemens Schiestl, MD, Kathrin Neuhaus, MD, Martin Meuli, MD, Melinda Farkas, PhD, Fabienne Hartmann-Fritsch, PhD, Julia Elrod, MD, Jenny Bressan, Ernst Reichmann, PhD, Sophie Böttcher-Haberzeth, MD
E-Jahr:2024
Jahr:08 August 2024
Umfang:9 S.
Illustrationen:Illustrationen
Fussnoten:Gesehen am 08.10.2024
Titel Quelle:Enthalten in: Journal of burn care & research
Ort Quelle:Philadelphia, Pa. : Lippincott Williams & Wilkins, 1980
Jahr Quelle:2024
Band/Heft Quelle:(2024), Artikel-ID irae150, Seite 1-9
ISSN Quelle:1559-0488
Abstract: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 10 pediatric patients in a Phase I clinical trial after transplantation. The goal of this article was to report on 48-month long-term results. The pediatric participants of the phase I clinical trial were followed up at yearly visits up to 5 years after transplantation. Safety parameters, including the 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. Of the 10 patients treated with denovoSkin in this phase I clinical trial, 7 completed the 5-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 using 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 is currently ongoing to further evaluate the safety and efficacy of this novel skin substitute. Clinicaltrials.gov identifier NCT02145130.
DOI:doi:10.1093/jbcr/irae150
URL:Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.

kostenfrei: Volltext: https://doi.org/10.1093/jbcr/irae150
 DOI: https://doi.org/10.1093/jbcr/irae150
Datenträger:Online-Ressource
Sprache:eng
K10plus-PPN:1905080158
Verknüpfungen:→ Zeitschrift

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