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A Phase 1/2 Study of a Combination of FCX-013 (Genetically-Modified Autologous Human Dermal Fibroblasts) Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea)

Trial Profile

A Phase 1/2 Study of a Combination of FCX-013 (Genetically-Modified Autologous Human Dermal Fibroblasts) Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 15 May 2019

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At a glance

  • Drugs FCX-013 (Primary) ; Veledimex (Primary)
  • Indications Circumscribed scleroderma
  • Focus Adverse reactions
  • Sponsors Fibrocell Technologies
  • Most Recent Events

    • 15 May 2019 According to Fibrocell media release, the company projects that safety and efficacy data for the adult patients will be available in mid-2020.
    • 27 Mar 2019 According to Fibrocell media release, company is currently enrolling patients in phase 1 portion and expects to complete enrollment in this portion in the third quarter of 2019.
    • 05 Sep 2018 According to Fibrocell media release, U.S. Food and Drug Administration (FDA) The Phase 1 portion will enroll adult patients, and dosing for the first three adult patients will be staggered prior to dosing the rest of the trials population. Fibrocell intends to include pediatric patients in the Phase 2 portion of the trial after submission and approval of safety and activity data from the adult Phase 1 patients from the FDA and the Data Safety Monitoring Board for the trial.
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