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A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa
Sponsor: Castle Creek Biosciences, LLC.
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
Official title: A Pivotal Phase 3 Study of FCX-007 (Genetically-Modified Autologous Human Dermal Fibroblasts) for Recessive Dystrophic Epidermolysis Bullosa
Key Details
Gender
All
Age Range
2 Years - Any
Study Type
INTERVENTIONAL
Enrollment
6
Start Date
2020-06-09
Completion Date
2037-07
Last Updated
2026-03-18
Healthy Volunteers
No
Interventions
FCX-007 (dabocemagene autoficel; see below for FCX-007 description)
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.
Locations (5)
Stanford University
Stanford, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
Solutions Through Advanced Research, Inc.
Jacksonville, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
Dell Children's Medical Group
Austin, Texas, United States