Human Acellular Vessel for Vascular Trauma

Recruiting in Palo Alto (17 mi)

+31 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: Humacyte, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial tests a special type of blood vessel called a Human Acellular Vessel (HAV) in adults with serious blood vessel injuries below the neck. The HAV is used to replace or bypass damaged vessels, helping restore blood flow. The study will follow patients for several years after the procedure. The Human Acellular Vessel (HAV) is a bioengineered conduit developed by Humacyte, Inc., known for its off-the-shelf availability and resistance to infection, making it ideal for complex revascularization scenarios.

Eligibility Criteria

This trial is for adults aged 18-85 with severe vascular injuries below the neck needing reconstructive surgery. Participants must be able to understand and follow study procedures, or have a witness who can attest to their ability if unconscious. They should not be at high risk of limb amputation, pregnant, recently in another study, employees of the sponsor or related to the investigator, nor have conditions preventing long-term antiplatelet therapy.

Inclusion Criteria

I can understand and follow the study's requirements.

The damaged blood vessel is no longer than 38cm and matches the size of the 6mm Human Acellular Vessel, as determined by the treating surgeon.

I or my relative can and agree to give informed consent.

+4 more

Exclusion Criteria

Employees of the sponsor or patients who are employees or relatives of the investigator

My limb might be amputated despite attempts to save it due to severe injury.

Your injury severity score is very high.

+7 more

Participant Groups

The trial studies how well a Human Acellular Vessel (HAV) works as a replacement or bypass for damaged blood vessels in two groups: one with torso injuries and one with limb injuries. All participants will receive HAV implants using standard surgical techniques without comparison to other treatments.

1Treatment groups

Experimental Treatment

Group I: Human Acellular Vessel (HAV)Experimental Treatment1 Intervention

Patients with life or limb threatening traumatic injury to an arterial vessel in the limb or torso, other than the heart, will be implanted with the Humacyte Human Acellular Vessel (HAV) as an interposition vessel or bypass using standard vascular surgical techniques.