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
Latest Information Update: 13 Aug 2024
At a glance
- Drugs Human acellular vessel-Humacyte (Primary)
- Indications Vascular injuries
- Focus Adverse reactions; Registrational; Therapeutic Use
- Sponsors Humacyte
- 09 Aug 2024 According to a Humacyte media release, the U.S. Food and Drug Administration (FDA) will require additional time to complete its review of its Biologic License Application (BLA) for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication.
- 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.