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Prospective, Open-label, Uncontrolled Clinical Trial to Assess the Safety and Efficacy of Autologous Cultured Epidermal Grafts Containing Epidermal Stem Cells Genetically Modified With a Gamma-retroviral (rv) Vector Carrying COL7A1 cDNA for Restoration of Epidermis in Patients With Recessive Dystrophic Epidermolysis Bullosa.

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Prospective, Open-label, Uncontrolled Clinical Trial to Assess the Safety and Efficacy of Autologous Cultured Epidermal Grafts Containing Epidermal Stem Cells Genetically Modified With a Gamma-retroviral (rv) Vector Carrying COL7A1 cDNA for Restoration of Epidermis in Patients With Recessive Dystrophic Epidermolysis Bullosa.

Status: Discontinued
Phase of Trial: Phase I/II

Latest Information Update: 12 Sep 2022

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At a glance

  • Drugs COL7A1 encoding stem cell therapy (Primary)
  • Indications Epidermolysis bullosa dystrophica
  • Focus Adverse reactions; First in man
  • Acronyms HOLOGENE7
  • Sponsors Holostem Terapie Avanzate

    • Most Recent Events

    • 15 Feb 2022 Status changed from active, no longer recruiting to discontinued.
    • 10 Aug 2021 Planned End Date changed from 1 Dec 2021 to 1 Sep 2021.
    • 10 Aug 2021 Planned primary completion date changed from 1 Dec 2021 to 1 Sep 2021.

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