← Back to Search

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

Able to communicate meaningfully with investigative staff, and able to comply with entire study procedures. If the patient is unconscious, then information from a reliable witness indicates that the patient would normally be able to comply with study procedures

Patient or relative is able, willing and competent to give informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 36 months

Awards & highlights

Study Summary

This trial will test whether the Human Acellular Vessel (HAV) is safe and effective for use in adults with vascular trauma below the neck who are undergoing vascular reconstructive surgery.

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.Check my eligibility

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.See study design

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

Select...

I can understand and follow the study's requirements.

Select...

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

Select...

Using my own veins for the graft is not possible or preferred due to urgent need for surgery or other issues.

Select...

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Frequency and Severity of Adverse Events

Secondary outcome measures

Frequency of HAV aneursym formation

Frequency of HAV infection

Frequency of HAV of hemodynamically significant stenosis (>70% by duplex ultrasound criteria)

+11 more

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%

Bronchitis, Diverticulitis, Groin infection, Osteomyelitis, Rhinovirus infection

27%

Cough, Pleural effusion, Pulmonary mass

27%

Implant site extravasation, Peripheral swelling

27%

Impaired healing, Oedema peripheral, Pain, Vascular stent restenosis

20%

Dizziness, Headache, Neuralgia

20%

Gout, Hyperuricaemia, Vitamin B12 deficiency

20%

Dermatitis, Skin hyperpigmentation, Skin ulcer

13%

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

13%

Pleural effusion, Respiratory failure

13%

Angina pectoris, Coronary artery disease

13%

Anxiety, Insomnia

13%

Pulse absent, Scan myocardial perfusion abnormal

Corona virus infection

Hyperglycaemic hyperosmolar nonketotic syndrome

Lymphadenopathy

Anemia

Gastrointestinal hemorrhage

Acute kidney injury

Arterial insufficiency

Nausea

Cholecystitis

Renal cyst

Cardiac failure acute

Adenocarcinoma of colon

100%

80%

60%

40%

20%

Study treatment Arm

HAV 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 / 5Eligibility criteria met

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

285 Previous Clinical Trials

245,087 Total Patients Enrolled

Media Library

Human Acellular Vessel (HAV) (Acellular Tissue Matrix) Clinical Trial Eligibility Overview. Trial Name: NCT03005418 — Phase 2 & 3

Vascular Injury Research Study Groups: Human Acellular Vessel (HAV)

Vascular Injury Clinical Trial 2023: Human Acellular Vessel (HAV) Highlights & Side Effects. Trial Name: NCT03005418 — Phase 2 & 3

Human Acellular Vessel (HAV) (Acellular Tissue Matrix) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03005418 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this trial a pioneering endeavor?

"Since 2016, the research community has been intrigued by Human Acellular Vessel (HAV). After a Phase 1 trial of 355 patients sponsored by Humacyte Inc., HAV was granted its official drug approval. Nowadays there are 8 countries and 69 cities running 6 active trials dedicated to this treatment."

Answered by AI

Are there any Canadian medical institutions conducting this research?

"This trial is present at 19 locations, such as Ernest E Moore Shock Trauma Center at Denver Health in Denver, Grady Memorial Hospital in Atlanta, and Duke University Hospital in Durham."

Answered by AI

How numerous is the cohort of participants in this clinical experiment?

"The study sponsor, Humacyte Inc., must recruit 100 participants with the correct inclusion criteria to execute this trial. These individuals will be sourced from Ernest E Moore Shock Trauma Center at Denver Health in Colorado and Grady Memorial Hospital in Georgia."

Answered by AI

Are there records of prior investigations concerning Human Acellular Vessel (HAV)?

"The initial research on Human Acellular Vessel (HAV) was conducted in 2016 at St. George's Hospital and, to date, there are 7 completed studies. Currently 6 further trials can be found recruiting patients across Denver Colorado and other medical centres."

Answered by AI

Does my profile meet the criteria for involvement in this experiment?

"To be selected for the study, individuals must possess damage to their vascular system and fall between 18-85 years old. Approximately 100 participants are being welcomed into this research project."

Answered by AI

Is there regulatory approval for Human Acellular Vessel (HAV) usage?

"The safety of Human Acellular Vessel (HAV) was rated a 2 on our scale, as the Phase 2 trial has provided some evidence of its security but no indications of effectiveness."

Answered by AI

Does the eligibility for this trial extend to individuals under 80 years old?

"To be eligible for this clinical trial, participants must have an age between 18 and 85 years old. Additionally, other trials exist with a younger patient population (18 or under) comprising of 130 studies and 618 trials targeting seniors 65+."

Answered by AI

Is this experiment actively seeking participants?

"Per clinicaltrials.gov, this medical trial is actively searching for participants since its inception on September 1st 2018 and up to the most recent update of August 18th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Humacyte Human Acellular Vessel (HAV) in Patients With Vascular Trauma

2018. "Humacyte Human Acellular Vessel (HAV) in Patients With Vascular Trauma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03005418.

All > Trauma