72 Participants Needed

Human Acellular Vessel for Vascular Trauma

Recruiting at 31 trial locations
KN
KD
ET
LS
MT
Overseen ByMark Tulchinskiy, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2 & 3
Sponsor: Humacyte, Inc.
Must be taking: Antiplatelets
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

SP

Shamik Parikh, MD

Principal Investigator

Humacyte, Inc.

Are You a Good Fit for This Trial?

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.
See 3 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.
See 7 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Human Acellular Vessel (HAV)Experimental Treatment1 Intervention

Find a Clinic Near You

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+
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