Status:
COMPLETED
Trial To Assess Efficacy Of A Chimeric Skin In Patients With Epidermolysys Bullosa
Lead Sponsor:
Tigenix S.A.U.
Conditions:
EPIDERMOLYSIS BULLOSA
Eligibility:
All Genders
28+ years
Phase:
PHASE2
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 ha...
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...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Patients of both sexes over 28 days of age.
- Patients with recessive dystrophic epidermolysis bullosa diagnosed by clinical and historical criteria with severe skin syndactyly in whom reconstructive surgery is indicated.
- Patients whose legal guardians have given written informed consent for participation in the study before any study procedure is performed.
- Patients aged ≥ 12 years who have given written informed consent for participation in the study before any study procedure is performed.
- Exclusion criteria:
- Women of childbearing age not using effective contraceptive methods (oral contraception)
- Pregnant or nursing women
- Documented or suspected hypersensitivity to any of the therapeutic agents included in the study, including anaesthetic drugs.
- Patients with a history of malignant tumor in the past 5 years
- Patients with a diagnosis of active tuberculosis at the time of recruitment
- Patients with prior positive markers for any of the following pathogens: hepatitis b and c, hiv-1 and hiv-2
- Patients with a history of clinically relevant hepatic, gastrointestinal, haematological, pulmonary, or neurological disease no directly related to epidermolysis bullosa.
- Any other medical condition which, in the investigator´s judgment, might interfere with optimal participation in the study or involve a significant risk for the patient.
- Alcoholism, drug addiction, psychiatric disorders, or other factors present in legal guardians which,in the investigator´s judgment may complicate patient participation in the study.
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00987142
Start Date
December 1 2006
End Date
May 1 2010
Last Update
August 1 2019
Active Locations (2)
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1
Fundación Mir-Mir
Barcelona, Spain
2
Hospital La Paz
Madrid, Spain