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)

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 02 Oct 2017

At a glance

  • Drugs GM-HDF-COL7 (Primary)
  • Indications Epidermolysis bullosa
  • Focus Adverse reactions
  • Sponsors Fibrocell Technologies
  • Most Recent Events

    • 02 Oct 2017 According to a Fibrocell Science media release, interim results from this trial will presented at the annual Partnering Forum, part of the Cell & Gene Meeting 2017.
    • 26 Sep 2017 According to an Fibrocell Science media release, The Data Safety Monitoring Board reviewed the interim data and allowed continuation of enrollment and dosing. With data from the first three patients meeting the primary trial objective of safety, the Company plans to increase expression and dosing FCX-007.
    • 26 Sep 2017 Interim results (n=3) presented in a Fibrocell Science Media Release.
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