At a glance
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A Pivotal Phase 3 Study of FCX-007 (Genetically-Modified Autologous Human Dermal Fibroblasts) for Recessive Dystrophic Epidermolysis Bullosa
In Brief
A Phase 3 clinical trial evaluating FCX-007 (dabocemagene autoficel; see below for FCX-007 description) for Recessive Dystrophic Epidermolysis Bullosa. Active but no longer recruiting, targeting 6 participants across 5 sites.
Detailed Summary
The purpose of this study is to determine whether administration of FCX-007 in addition to standard of care improves wound healing as compared to standard of care alone (control) in children, adolescents, and adults with Recessive Dystrophic Epidermolysis Bullosa. Funding Source - FDA OOPD
Study Details
Timeline
Interventions
FCX-007 is comprised of fibroblasts isolated from the subject's skin biopsies which are genetically corrected with the full length COL7A1 gene encoding for type VII collagen.