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A Phase 2/3 Study for the Evaluation of Safety and Efficacy of Humacyte's Human Acellular Vessel for Vascular Replacement or Reconstruction in Patients With Life or Limb-threatening Vascular Trauma

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Trial Profile

A Phase 2/3 Study for the Evaluation of Safety and Efficacy of Humacyte's Human Acellular Vessel for Vascular Replacement or Reconstruction in Patients With Life or Limb-threatening Vascular Trauma

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

Latest Information Update: 14 Feb 2024

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At a glance

  • Drugs Human acellular vessel-Humacyte (Primary)
  • Indications Vascular injuries
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Humacyte

    • Most Recent Events

    • 09 Feb 2024 According to a Humacyte media release, the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to Humacyte's Biologics License Application (BLA) seeking approval of the Human Acellular Vessel (HAV) in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible.The Prescription Drug User Fee Act (PDUFA) date is August 10, 2024.
    • 17 Nov 2023 According to a Humacyte media release, Charles J. Fox is a clinical investigator of this study.
    • 17 Nov 2023 According to a Humacyte media release, clinical trial results from this study were presented at at the VEITHsymposium, a major vascular surgery conference in New York City.
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