Human Acellular Vessel for Vascular Trauma

Recruiting at 31 trial locations

Overseen By Mark Tulchinskiy, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Humacyte, Inc.

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 36 months

72 Participants Needed

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.

Research Team

Shamik Parikh, MD

Principal Investigator

Humacyte, Inc.

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are implanted with a Humacyte Human Acellular Vessel (HAV) as an interposition vessel or bypass using standard vascular surgical techniques

Up to 36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at standard of care visits, and physical exams and ultrasounds at month 24 and month 36

36 months

Treatment Details

Interventions

• Human Acellular Vessel (HAV)

Trial Overview 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.

Participant Groups

Group I: Human Acellular Vessel (HAV) Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Humacyte, Inc.

Lead Sponsor

Trials

11

Recruited

960+

Atlantic Research Group

Collaborator

Trials

9

Recruited

600+

U.S. Army Medical Research and Development Command

Collaborator

Trials

296

Recruited

249,000+