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A Multicentre, Intra-patient Randomised Controlled Phase III Study to Confirm the Efficacy and Safety of denovoSkin™, a Bilayer Engineered Collagen-based Skin Graft Composed of Autologous Fibroblasts and Keratinocytes, for the Treatment of Patients With Deep Partial and Full-thickness Burns

Trial Profile

A Multicentre, Intra-patient Randomised Controlled Phase III Study to Confirm the Efficacy and Safety of denovoSkin™, a Bilayer Engineered Collagen-based Skin Graft Composed of Autologous Fibroblasts and Keratinocytes, for the Treatment of Patients With Deep Partial and Full-thickness Burns

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 20 Aug 2026

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At a glance

  • Drugs EHSG-KF (Primary)
  • Indications Burns
  • Focus Registrational; Therapeutic Use
  • Sponsors CUTISS

Most Recent Events

  • 10 Aug 2026 Planned End Date changed from 30 Jun 2028 to 30 Jun 2029.
  • 10 Aug 2026 Planned primary completion date changed from 31 Dec 2026 to 30 Jun 2027.
  • 04 Jun 2026 This trial has been completed in Portugal and Belgium, according to Clinical Trials Information System.

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