Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Children

Phase 2 Active not recruiting 12 enrolled CUTISS AG Julius Clinical · collab Sintesi Research Srl · collab University Hospital, Zürich · collab University of Zurich · collab Wyss Zurich · collab

RandomizedSingle-groupOpen-labelTreatment

Summary

This phase IIb trial aims to evaluate the efficacy and safety of EHSG-KF (synonym denovoSkin) in comparison to meshed STSG in children with partial deep dermal and full thickness burns.

Timeline

Start: 2017-10-25
Primary completion: 2026-06
Completion: 2028-06

Publications

Schiestl C, Neuhaus K, Meuli M, Farkas M, Hartmann-Fritsch F, Elrod J, Bressan J, Reichmann E, Bottcher-Haberzeth S. Long-Term Outcomes of a Cultured Autologous Dermo-Epidermal Skin Substitute in Children: 5-Year Results of a Phase I Clinical Trial. J Burn Care Res. 2025 Mar 4;46(2):326-334. doi: 10.1093/jbcr/irae150.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	EHSG-KF	Other / unclassified	—	—

Indications

No indication recorded.