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A Phase I/II Study of FCX-007 (Genetically-Modified Autologous Human Dermal Fibroblasts) for Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Trial Profile

A Phase I/II Study of FCX-007 (Genetically-Modified Autologous Human Dermal Fibroblasts) for Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 24 May 2019

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At a glance

  • Drugs FCX 007 (Primary)
  • Indications Epidermolysis bullosa
  • Focus Adverse reactions
  • Sponsors Fibrocell Technologies
  • Most Recent Events

    • 21 May 2019 Planned primary completion date changed from 1 Apr 2020 to 1 Jun 2020.
    • 20 May 2019 Planned primary completion date changed from 1 Dec 2018 to 1 Apr 2020.
    • 27 Mar 2019 According to a Fibrocell Science media release, To date, FCX-007 has been evaluated in eight wounds across five adult RDEB patients and dosing of a sixth patient has been completed recently. Remaining Phase 2 patients who have not received dosing will be contacted to determine if they would agree to reconsent into the Phase 3 trial.
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