Trial To Assess Efficacy Of A Chimeric Skin In Patients With Epidermolysys Bullosa
- Conditions
- EPIDERMOLYSIS BULLOSA
- Interventions
- Device: Occlusive non adherent dressing
- Registration Number
- NCT00987142
- Lead Sponsor
- Tigenix S.A.U.
- Brief Summary
A phase II, comparative, open label, prospective, multicentre clinical trial where each patient will undergo two procedures; implant of a patch of cultured chimeric skin (experimental therapy) in a half of the skin lesion and an occlusive non-adherent dressing (control) in the other half for 12 months of follow-up in two Spanish centres.
- Detailed Description
Reconstruction of interdigital commisures in patients with severe skin syndactyly using laminar grafts that will be uniformly and systematically taken with an electrical or compressed air dermatome on an aseptic area and with the same extent and depth in microns in all patients.
Immediately after the surgical procedure, a patch of cultured chimeric skin (experimental therapy) will be implanted in a half of the skin defect of the patient, and an occlusive non - adherent dressing (control) will be implanted in the other half.
Patients will initially be followed up every two days until epithelisation occurs (approximately 21 days after surgery) and at 3,8,and 12 months of follow-up.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CX501 CX501 Cultured chimeric skin Non adherent dressing Occlusive non adherent dressing Occlusive non adherent dressing
- Primary Outcome Measures
Name Time Method Time to epithelization 21 days
- Secondary Outcome Measures
Name Time Method Fibroblast persistence 3, 8 and 12 months Incidence of Adverse Events 12 months
Trial Locations
- Locations (2)
Fundación Mir-Mir
🇪🇸Barcelona, Spain
Hospital La Paz
🇪🇸Madrid, Spain