RecruitingPhase 1Phase 2NCT07193134

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

Genetically Modified Epidermolysis Bullosa Self-Assembled Skin Substitute (GMEB-SASS) to Treat Patients Suffering From Recessive Dystrophic Epidermolysis Bullosa (RDEB)


Sponsor

CHU de Quebec-Universite Laval

Enrollment

9 participants

Start Date

Jan 7, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 7 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Genetically Modified Epidermolysis Bullosa Self-Assembled Skin Substitute (GMEB-SASS) for people with epidermolysis bullosa dystrophica, recessive, rdeb, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGGenetically Modified Epidermolysis Bullosa Self-Assembled Skin Substitute (GMEB-SASS)

Wound debridement will be performed, followed by the application of temporary allogeneic skin grafts for 3-5 days. The allografts will then be removed, and the GMEB-SASS grafts will be applied.


Locations(1)

The Hospital for Sick Children (SickKids)

Toronto, Ontario, Canada

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NCT07193134


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