Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Lab-Grown blood vessels could save limbs after trauma

NCT ID NCT03005418

Disease control Sponsor: Humacyte, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This trial is testing whether a lab-grown blood vessel made from human collagen can safely replace damaged arteries in people with life- or limb-threatening vascular injuries below the neck. Participants receive the artificial vessel as a bypass or replacement during emergency surgery. The study aims to see if the vessel stays open and functioning without additional procedures.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Acellular Tissue Engineered Vessel (ATEV) — a lab-grown blood vessel made from human collagen
What this could lead to
If successful, this could provide a ready-made, off-the-shelf blood vessel for emergency trauma surgery, reducing the need to take a vein from another part of the body.
What could go wrong
This is an early-stage trial with no control group, so results may not prove the vessel is better than standard options. Risks include blood clots, infection, or vessel failure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

72 people

The number who actually took part.

Started

Sep 2018

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 * Preoperative imaging or clinical examination indicates the damaged vessel has a defect length of ≤ 38cm and is appropriately size matched to the 6 mm Acellular Tissue Engineered Vessel (ATEV) per the judgment of the treating surgeon taking into account vasoconstriction and situational inflow and outflow considerations. * Autologous vein graft is either not feasible in the judgment of the treating surgeon (e.g. because of lack of availability of suitable conduit, presence of severe venous insufficiency) or is not desirable because of the urgency of revascularization * 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 * Life expectancy of at least 1 year Exclusion Criteria: * Mangled Extremity Severity Score (MESS) of ≥ 7 * 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) * ATEV may not be used for coronary artery repair * Known pregnant women * Known medical condition which would preclude long term antiplatelet therapy after resolution of acute injuries * Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the ATEV * Previous exposure to ATEV * Known participation in any investigational study within the last 30 days * Employees of the sponsor or patients who are employees or relatives of the investigator

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Trauma are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

injury Vascular System Injuries

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Trauma Vascular system injury

Contacts and locations

Locations

  • Atrium Health Wake Forest Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

  • Cedars-Sinai Medical Cener

    Los Angeles, California, 90048, United States

  • Cooper University Hospital

    Camden, New Jersey, 08103, United States

  • Duke University Hospital

    Durham, North Carolina, 27705, United States

  • Ernest E Moore Shock Trauma Center at Denver Health

    Denver, Colorado, 80204, United States

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303, United States

  • Jackson South Medical Center

    Miami, Florida, 33136, United States

  • Jacob Medical Center at UC San Diego

    La Jolla, California, 92037, United States

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Keck Hospital of University of Southern California (USC)

    Los Angeles, California, 90033, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Penn Presbyterian Medical Center

    Philadelphia, Pennsylvania, 19104, United States

  • R Adams Cowley Baltimore Shock Trauma

    Baltimore, Maryland, 21201, United States

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103, United States

  • Ryder Trauma Center

    Miami, Florida, 33136, United States

  • Saint Louis University (SLU)

    St Louis, Missouri, 63110, United States

  • Shaare Zedek Medical Center

    Jerusalem, 9103102, Israel

  • Soroka Medical Center - Vascular Surgery Department

    Beersheba, 8410101, Israel

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140, United States

  • The University of Texas - Dell Medical School

    Austin, Texas, 78701, United States

  • UCI Medical Center

    Orange, California, 92868, United States

  • UF Health Jacksonville

    Jacksonville, Florida, 32209, United States

  • University California, Davis

    Sacramento, California, 95817, United States

  • University of California San Diego (UCSD) Medical Center

    San Diego, California, 92103, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Wake Forest School of Medicine

    Winston-Salem, North Carolina, 27157, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.