drugset / Trial / NCT01908088

Autologous Transplantation of Cultured Fibroblast on Amniotic Membrane in Patients With Epidermolysis Bullosa

NCT01908088 ↗

Phase 1 Completed 6 enrolled Royan Institute Hazrat Fatemeh Hospital · collab
NaSingle-groupOpen-labelTreatment

Summary

Epidermolysis Bullosa (EB) is a blistering disease that is caused by defective anchoring fibrils and hemidesmosome in basement membrane of the skin layer. EB is inherited either autosomal or recessive and has 3 types. Recessive Dystrophic Epidermolysis Bullosa (RDEB) is severe with some morbidity such as mitten hand deformity. The management of these patients is very difficult because no effective treatment has been known yet. The EB patients with mitten hand deformity need surgery to have a biologic dressing for areas of hand which is without the skin. In this study the investigators assess the safety of autologous transplantation of cultured fibroblast on amniotic membrane (AM,as coverage) for them.

Timeline

Start
2010-07
Primary completion
2012-09
Completion
2013-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Cell transplantation Unknown — —