Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Next Previous
X
Search
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: 13 Aug 2024

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

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

    • Most Recent Events

    • 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.

You need to be a logged in or subscribed to view this content Request demo

If your organization or you do not have a subscription, try one of the following:
  • Contacting your organization’s admin about adding this content to your AdisInsight subscription
  • Buying a PDF version of any individual profile
  • Request a free trial
If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top