Genetically modified autologous human dermal fibroblasts - Fibrocell

Drug Profile

Genetically modified autologous human dermal fibroblasts - Fibrocell

Alternative Names: FCX-007; Fibroblast epidermolysis bullosa cell therapy -Fibrocell/Intrexon; Fibroblast epidermolysis bullosa gene therapy -Fibrocell/Intrexon; Fibroblast recessive dystrophic epidermolysis bullosa cell therapy - Fibrocell/Intrexon; Fibroblast recessive dystrophic epidermolysis bullosa gene thearpy - Fibrocell/Intrexon; Fibroblast-RDEB-cell-therapy-Fibrocell/Intrexon; Fibroblast-RDEB-gene-therapy-Fibrocell/Intrexon; Genetically modified human dermal fibroblast-collagen VII; Genetically-Modified Autologous Human Dermal Fibroblasts; GM-HDF-COL7

Latest Information Update: 25 May 2018

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At a glance

  • Originator Fibrocell Science
  • Developer Fibrocell Science; Intrexon Corporation
  • Class Cell therapies; Fibroblast cell therapies; Gene therapies; Skin disorder therapies
  • Mechanism of Action Cell replacements; Gene expression modulators; Tissue replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Epidermolysis bullosa
  • New Molecular Entity No

Highest Development Phases

  • Phase I/II Epidermolysis bullosa

Most Recent Events

  • 21 May 2018 Updated interim adverse events and efficacy data from a phase I/II trial in Epidermolysis bullosa released by Fibrocell Science
  • 30 Jan 2018 The US FDA approves inclusion of paediatric patients in the phase II portion of a phase I/II trial in Epidermolysis bullosa
  • 26 Sep 2017 Interim efficacy, pharmacodynamics and adverse events data from a phase I/II trial in Epidermolysis bullosa released by Fibrocell Science
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