A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa
Trial ID or NCT#
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
A Pivotal Phase 3 Study of FCX-007 (Genetically-Modified Autologous Human Dermal Fibroblasts) for Recessive Dystrophic Epidermolysis Bullosa
- - Male or female ≥2 years of age at the Screening visit. - Clinical diagnosis of RDEB with confirmation of COL7A1 genetic mutation. Key
- - Medical instability limiting ability to travel to the investigative site. - Active infection with human immunodeficiency virus, hepatitis B or hepatitis C. - The presence of COL7 antibodies. - Evidence of systemic infection. - Evidence or history of squamous cell carcinoma at the site to be injected. - Evidence of or history of metastatic squamous cell carcinoma. - Known allergy to any of the constituents of the product. - Female who is pregnant or breastfeeding. - Receipt of a chemical or biological intervention for the specific treatment of RDEB in the past three (3) months prior to screening or anticipated/planned during the screening and treatment period for this study.
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Kunju J Sridhar, PhD