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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 belowSelect...
I need surgery for a serious injury to an artery in my arm, leg, or torso.
Select...
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
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 • NCT0288785967%
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%
Bronchitis, Diverticulitis, Groin infection, Osteomyelitis, Rhinovirus infection
27%
Cough, Pleural effusion, Pulmonary mass
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
7%
Arterial insufficiency
7%
Anemia
7%
Adenocarcinoma of colon
7%
Lymphadenopathy
7%
Cardiac failure acute
7%
Gastrointestinal hemorrhage
7%
Corona virus infection
7%
Cholecystitis
7%
Renal cyst
7%
Nausea
7%
Hyperglycaemic hyperosmolar nonketotic syndrome
7%
Acute kidney injury
100%
80%
60%
40%
20%
0%
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
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.
Management of venous trauma.Post-traumatic arteriovenous fistulae of the extremities: A case series.Management and outcome of pediatric vascular injuries.
Find a Location
Who is running the clinical trial?
Humacyte, Inc.Lead Sponsor
10 Previous Clinical Trials
887 Total Patients Enrolled
Atlantic Research GroupOTHER
8 Previous Clinical Trials
523 Total Patients Enrolled
U.S. Army Medical Research and Development CommandFED
289 Previous Clinical Trials
245,999 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can understand and follow the study's requirements.My limb might be amputated despite attempts to save it due to severe injury.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.Your injury severity score is very high.You have been exposed to hepatitis A virus before.I cannot take long-term antiplatelet medication due to a health condition.I or my relative can and agree to give informed consent.I do not have severe injuries that make survival unlikely.Using my own veins for the graft is not possible or preferred due to urgent need for surgery or other issues.I need surgery for a serious injury to an artery in my arm, leg, or torso.I am not using HAV for coronary artery repair.You are expected to live for at least 1 year.I am between 18 and 85 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Human Acellular Vessel (HAV)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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