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

NCT07193134 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2026-03-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Genetically 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.

Sponsors & Collaborators

  • CHU de Quebec-Universite Laval

    lead OTHER

Principal Investigators

  • Lucie Germain, PhD · CHU de Québec-Université Laval

  • Elena Pope, MD, FRCPC · The Hospital for Sick Children (SickKids)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-07
Primary Completion
2030-12-31
Completion
2035-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07193134 on ClinicalTrials.gov