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

Recruiting Phase 1 Phase 2 Interventional Study
RDEB Recessive Dystrophic Epidermolysis Bullosa Epidermolysis Bullosa Dystrophica, Recessive
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
7 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
9 (estimated)
Sponsor
CHU de Quebec-Universite Laval · Other
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About This Trial
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 pr…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Age Learning phase: * Subjects 1 to 3: Eighteen (18) years old or older. * Subjects 4 to 6: Twelve (12) years old or older. * Subjects 7 to 9: Seven (7) years old or older. Other Inclusion Criteria: * Clinical diagnosis of recessive dystrophic epidermolysis bullosa (RDEB) …
Contacts

Lucie Germain, PhD

418-525-4444

lucie.germain@fmed.ulaval.ca

CONTACT