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

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.

NCT Number	NCT07193134
Lead Sponsor	CHU de Quebec-Universite Laval
Conditions	RDEB, Recessive Dystrophic Epidermolysis Bullosa, Epidermolysis Bullosa Dystrophica, Recessive
Enrollment	9 participants
Start Date	2026-01-07
Primary Completion	2030-12 (estimated)
Study Completion	2035-12 (estimated)
Updated on ClinicalTrials.gov	2026-03-18