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

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cellerix; Tigenix S.A.U.

Criteria

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.