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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)

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 12 Dec 2018

At a glance

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

    • 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.
    • 09 Aug 2018 Status changed from planning to recruiting, according to a Fibrocell media release.
    • 18 Apr 2018 According to Fibrocell media release, company expects to begin enrolment in this trial in the third quarter of 2018.
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