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SEC Filings


8-K
FIBROCELL SCIENCE, INC. filed this Form 8-K on 05/10/2018
Entire Document
 
 
FCX-013 Phase 1/2 Clinical Trial Design A Phase 1/2 Study of a Combination of FCX-013 (Genetically-Modified Human Title Dermal Fibroblasts) plus Veledimex for the Treatment of Moderate to Severe Scleroderma (Morphea) Primary Objective To evaluate the safety of a single intradermal injection session of FCX-013 To evaluate fibrosis resolution through the following measurements: Secondary Objectives • Histology • MRI, ultrasound and durometry • Various scale assessments • 10 (approximately 5 per Phase) Number of Patients • Staggered enrollment for first 3 adults • Starting with adult patients; addition of pediatric patients after submission and approval of safety and activity data from adult patients to FDA and the DSMB Status Initiate enrollment of Phase 1 adult patients in 3Q2018 16