What is the mechanism of action of this treatment?

The most common treatments for vascular injury involve the use of vascular conduits, such as the Human Acellular Vessel (HAV), which serve to restore blood flow in damaged vessels. These conduits work by providing a scaffold that supports the growth of new vascular tissue, thereby re-establishing circulation and preventing tissue ischemia. This is particularly important for vascular injury patients as it helps to maintain limb viability, reduce the risk of complications like chronic venous hypertension, and improve overall recovery outcomes. The use of such conduits can be critical in both acute and long-term management of vascular injuries, ensuring that blood flow is promptly and effectively restored.

What side effects are associated with this type of intervention?

Common side effects of treatments for vascular injury, such as those involving vascular grafts like the Human Acellular Vessel (HAV), include infection at the surgical site, thrombosis, graft occlusion, and potential immune reactions. Surgical complications can also involve bleeding and damage to surrounding tissues. Long-term issues may include graft failure and the need for further interventions.

What prior FDA approvals exist?

The FDA has approved various treatments for vascular injury, particularly those involving vascular conduits to restore blood flow. Traditional treatments include synthetic grafts made from materials like Dacron and expanded polytetrafluoroethylene (ePTFE). These synthetic grafts are commonly used in vascular reconstructive surgeries to bypass or replace damaged vessels. Additionally, autologous vein grafts, where a patient's own vein is used, have been a standard approach. The Human Acellular Vessel (HAV) represents a novel approach, aiming to provide a bioengineered alternative that may offer improved biocompatibility and reduced risk of rejection compared to synthetic options.

What other types of research exist?

Promising novel alternatives to Human Acellular Vessel (HAV) for vascular injury patients include bioengineered blood vessels derived from stem cells, synthetic grafts made from advanced polymers, and tissue-engineered vascular grafts (TEVGs) that combine synthetic materials with biological components. These alternatives aim to improve biocompatibility, reduce the risk of infection, and enhance long-term patency rates.

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Acellular Tissue Matrix

Human Acellular Vessel for Vascular Trauma

Phase 2 & 3

Waitlist Available

Research Sponsored by Humacyte, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with life or limb threatening traumatic injury to an arterial vessel in the limb or torso, other than the heart, which requires replacement or reconstruction

Aged 18 to 85 years old, inclusive

Must not have

Limb at high risk of amputation despite vascular reconstruction (e.g., because of crush injury)

Catastrophic injuries that make survival unlikely (e.g. Abbreviated Injury Scale (AIS) > 5 or Injury Severity Score (ISS) >60)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

No Placebo-Only Group

Summary

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 the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects are not explicitly listed but may include typical risks associated with vascular surgery such as infection, inflammation at the implant site, clotting issues leading to reduced blood flow or blockage, immune reaction to HAV material and complications from long-term antiplatelet therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need surgery for a serious injury to an artery in my arm, leg, or torso.

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I am between 18 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I do not have severe injuries that make survival unlikely.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

HAV primary assisted patency

HAV primary patency

HAV secondary patency

Side effects data

From 2023 Phase 2 trial • 15 Patients • NCT02887859

67%

Arthralgia, Back pain, Muscle necrosis, Musculoskeletal pain, Pain in extremity, Tenosynovitis

60%

Anastomic stenosis, Arterial bypass stenosis, Arterial bypass thrombosis, continued in description

60%

Arterial stenosis, Haematoma, Intermittent claudication, Continued in description

27%

Cough, Pleural effusion, Pulmonary mass

27%

Bronchitis, Diverticulitis, Groin infection, Osteomyelitis, Rhinovirus infection

27%

Impaired healing, Oedema peripheral, Pain, Vascular stent restenosis

27%

Implant site extravasation, Peripheral swelling

20%

Gout, Hyperuricaemia, Vitamin B12 deficiency

20%

Dermatitis, Skin hyperpigmentation, Skin ulcer

20%

Dizziness, Headache, Neuralgia

13%

Pleural effusion, Respiratory failure

13%

Pulse absent, Scan myocardial perfusion abnormal

13%

Angina pectoris, Coronary artery disease

13%

Anxiety, Insomnia

13%

Post procedural swelling, Seroma, Vascular pseudoaneurysm thrombosis, Wound decomposition

Adenocarcinoma of colon

Arterial insufficiency

Anemia

Lymphadenopathy

Cardiac failure acute

Gastrointestinal hemorrhage

Corona virus infection

Cholecystitis

Renal cyst

Nausea

Hyperglycaemic hyperosmolar nonketotic syndrome

Acute kidney injury

100%

80%

60%

40%

20%

Study treatment Arm

HAV Treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Human Acellular Vessel (HAV)

2016

Completed Phase 3

~370

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for vascular injury involve the use of vascular conduits, such as the Human Acellular Vessel (HAV), which serve to restore blood flow in damaged vessels. These conduits work by providing a scaffold that supports the growth of new vascular tissue, thereby re-establishing circulation and preventing tissue ischemia. This is particularly important for vascular injury patients as it helps to maintain limb viability, reduce the risk of complications like chronic venous hypertension, and improve overall recovery outcomes. The use of such conduits can be critical in both acute and long-term management of vascular injuries, ensuring that blood flow is promptly and effectively restored.

Management of venous trauma.Post-traumatic arteriovenous fistulae of the extremities: A case series.Management and outcome of pediatric vascular injuries.