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.
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
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
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
Loading…
Loading trial locations…
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