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: 13 Nov 2017

At a glance

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

    • 13 Nov 2017 According to a company media release, Fibrocell expects to perform additional dosing of adult patients in the Phase 1 portion of the clinical trial in the fourth quarter of 2017. An RDEB adult has been enrolled as the first patient in the Phase 2 portion of this trial. Furthermore, upon obtaining allowance from the US FDA, the Company expects to initiate enrollment of pediatric patients in the Phase 2 portion of the trial in the first quarter of 2018.
    • 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.
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