NCT00987142

Trial To Assess Efficacy Of A Chimeric Skin In Patients With Epidermolysys Bullosa

A Comparative Open-Label Multicentre Clinical Trial To Assess The Efficacy And Safety Of A New Therapy With Cultured Chimeric Skin For The Treatment Of Skin Lesions In Patients With Epidermolysis Bullosa

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Tigenix S.A.U. · Industry
• Sex: All
• Age: 28 Days
• Healthy volunteers: Not accepted

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.

Conditions

• EPIDERMOLYSIS BULLOSA

Interventions

Type	Name	Description
DRUG	CX501	Cultured chimeric skin
DEVICE	Occlusive non adherent dressing	Application of an occlusive non adherent dressing in the skin donor site

Timeline

• Start date: 2006-12-01
• Primary completion: 2010-05-01
• Completion: 2010-05-01
• First posted: 2009-09-30
• Last updated: 2019-08-01

Locations

2 sites across 1 country: Spain