A Study of FCX-013 Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea)
Status:
Recruiting
Trial end date:
2036-01-01
Target enrollment:
Participant gender:
Summary
A two-component therapeutic consisting of FCX-013 and veledimex for the treatment of
localized scleroderma (or morphea). The first component, FCX-013, is autologous human
fibroblasts genetically-modified using lentivirus and encoded for matrix metalloproteinase 1
(MMP-1), a protein responsible for breaking down collagen. FCX-013 is designed to be injected
under the skin at the location of the fibrotic lesions where the genetically-modified
fibroblast cells will produce MMP-1 to break down excess collagen accumulation. With the
FCX-013 therapy, the patient will take an oral compound (Veledimex) to induce MMP-1 protein
expression from the injected cells. Once the fibrosis is resolved, the patient will stop
taking the oral compound which will stop further MMP-1 production from the injected cells.
FCX-013 plus veledimex is being developed in anticipation of improving skin function in
patients by resolving fibrotic lesions and normalizing dermal collagen production
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Castle Creek Biosciences, LLC. Fibrocell Technologies, Inc.