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GMEB-SASS: A Gene-Modified Skin Substitute for RDEB Treatment

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date changed from estimate of Jan 2026 to Jan 7, 2026v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Oct 2025 to Jan 2026
    • Site details revised
    v2
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study is being done to find out if a new type of skin graft, called GMEB-SASS, is safe and effective for helping wounds heal in people with RDEB (Recessive Dystrophic Epidermolysis Bullosa). The GMEB-SASS graft contains two types of living skin cells: keratinocytes and fibroblasts. It is made in a laboratory using a small sample of the patient's own skin. To help the patient's skin cells produce a missing protein called type VII collagen, scientists grow the patient's cells in the lab and use a virus-like tool (called a retroviral vector) to give the cells the correct instructions. This allows the cells to make the normal protein that is missing in people with RDEB. The graft is designed to be permanent, and the goal is to improve wound healing by replacing damaged skin cells with healthy ones.
Trial Details
NCT Number NCT07193134
Lead Sponsor CHU de Quebec-Universite Laval
Conditions
(from sponsor)		 RDEB, Recessive Dystrophic Epidermolysis Bullosa, Epidermolysis Bullosa Dystrophica, Recessive
Related terms Collagen Diseases, Congenital Abnormalities, Connective Tissue Diseases, Epidermolysis Bullosa, Epidermolysis Bullosa Dystrophica, Genetic Diseases, Inborn, Skin Abnormalities, Skin and Connective Tissue Diseases, Skin Diseases, Skin Diseases, Genetic, Skin Diseases, Vesiculobullous
Enrollment 9 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov