drugset / Trial / NCT03227146
Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents
Phase 2
Active not recruiting
14 enrolled
CUTISS AG
Julius Clinical · collabSintesi Research Srl · collabUniversity Hospital, Zürich · collabUniversity of Zurich · collabWyss 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 adults and adolescents with partial deep dermal and full thickness burns.
Timeline
- Start
- 2017-10-25
- Primary completion
- 2022-11-30
- Completion
- 2025-12-31
Outcome
Met primary endpoint
paper The expansion ratio for denovoSkin™ versus STSG was 7·0 times larger for denovoSkin™ (p < 0·001). PMID 41399471 ↗
release “Phase 2 clinical trial reaches efficacy endpoint with high statistical significance for lead product denovoSkin™ in adult and adolescent burn patients.” cutiss.swiss ↗
Publications
- Meuli M, Schiestl C, Hartmann-Fritsch F, Middelkoop E, Kim BS, Neuhaus K, Plock JA, Rittirsch D, van der Vlies CH, Azzena B, Marino D, Mujynya K, Farkas M, Bressan J, Reichmann E, Bottcher-Haberzeth S. Safety and efficacy of bio-engineered, autologous dermo-epidermal skin grafts in adolescent and adult burn patients: 1-year results of a prospective, randomized, controlled, multicenter phase IIB clinical trial. EClinicalMedicine. 2025 Nov 28;90:103665. doi: 10.1016/j.eclinm.2025.103665. eCollection 2025 Dec.
- 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.