Trial To Assess Efficacy Of A Chimeric Skin In Patients With Epidermolysys Bullosa (TCEB)
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|ClinicalTrials.gov Identifier: NCT00987142|
Recruitment Status : Completed
First Posted : September 30, 2009
Last Update Posted : June 14, 2011
|Condition or disease||Intervention/treatment||Phase|
|EPIDERMOLYSIS BULLOSA||Drug: CX501 Device: Occlusive non adherent dressing||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||December 2006|
|Actual Primary Completion Date :||May 2010|
|Actual Study Completion Date :||May 2010|
Cultured chimeric skin
Cultured chimeric skin
Active Comparator: Non adherent dressing
Occlusive non adherent dressing
Device: Occlusive non adherent dressing
Application of an occlusive non adherent dressing in the skin donor site
- Time to epithelization [ Time Frame: 21 days ]
- Fibroblast persistence [ Time Frame: 3, 8 and 12 months ]
- Incidence of Adverse Events [ Time Frame: 12 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00987142
|Hospital La Paz|
|Principal Investigator:||Juan Carlos López, MD||Hospital La Paz|