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Ex Vivo Gene Therapy Clinical Trial for RDEB Using Genetically Corrected Autologous Skin Equivalent Grafts

Study acronym: EBGraft
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor 2 versions Re-verified since Jan 27, 2025, no change to tracked fieldsv5-v6
  2. Notable Primary completion date: Jul 2021 to Jun 9, 2027
    • Trial status: Enrolling by Invitation to Active, Not Recruiting
    • Study completion date: Sep 2021 to Jun 9, 2027
    v4
  3. Minor Start date changed from estimate of Dec 2019 to Jan 10, 2020v3
  4. Minor Secondary endpoints: details revised at 1 of 13 entriesv2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This phase I/II clinical trial aims to treat 3 adult subjects with Recessive Dystrophic Epidermolysis Bullosa, expressing residual C7 levels, by genetically corrected autologous skin equivalent grafts on selected areas (up to 300 cm2).
Trial Details
NCT Number NCT04186650
Lead Sponsor Institut National de la Santé Et de la Recherche Médicale, France
Conditions
(from sponsor)
Epidermolysis Bullosa Dystrophica, Recessive
Related terms Epidermolysis Bullosa Dystrophica
Enrollment 3 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov