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Engineered blood vessel could simplify dialysis for kidney patients

NCT ID NCT03183245

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tested a lab-grown blood vessel (Human Acellular Vessel, or HAV) against the standard surgically created fistula in 242 people with end-stage kidney disease on hemodialysis. The goal was to see which option works better for providing reliable access to filter blood. The study measured how well each access type functioned at 6 months and how long it lasted without being abandoned.

What this could mean

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

Active substance
Human Acellular Vessel (HAV)
What this could lead to
If it works, this could provide a reliable, ready-to-use option for dialysis access, reducing the need for multiple surgeries.
What could go wrong
This is a completed phase 3 trial, but the HAV may not work as well as a natural fistula for everyone, and there are risks of infection or blockage.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

242 people

The number who actually took part.

Started

Sep 2017

Finished

Jun 2025

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 years and older

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: 1. Subjects with end-stage renal disease (ESRD), receiving HD via DC and are suitable for the creation of an AVF or implantation of AVG for HD access. 2. Subjects who plan to undergo HD at a dialysis unit of a participating dialysis provider for at least the first 6 months after SA creation. 3. Subjects aged at least 18 years at Screening. 4. Suitable anatomy for creation of a forearm or upper arm AVF and for implantation of straight or looped HAV in either the forearm or upper arm. 5. Hemoglobin ≥8 g/dL and platelet count ≥100,000 /mm3. 6. International Normalized Ratio (INR) ≤ 1.5. 7. Female subjects must be either: 1. Of non-childbearing potential, which is defined as post-menopausal (at least 1 year without menses prior to Screening) or documented surgically sterile or post hysterectomy (at least 1 month prior to Screening). 2. Or, of childbearing potential, in which case: i. Must have a negative urine or serum pregnancy test at Screening, and ii. Must agree to use at least one form of the following birth control methods for the duration of the study: * Established use of oral, injectable or implanted hormonal methods of contraception. * Placement of an intrauterine device or intrauterine system. * Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/ gel/ film/ cream/ suppository. 8. Subject, or legal representative, able to communicate effectively with investigative staff, competent and willing to give written informed consent, and able to comply with entire study procedures including all scheduled follow-up visits. 9. Life expectancy of at least 2 years. Exclusion Criteria: 1. Subjects who are optimal candidates for radiocephalic AVF as indicated by meeting ALL of the following criteria: 1. No previous failed AVF. 2. Cephalic vein diameter on ultrasound of more than 3.5mm. 3. Radial artery diameter on ultrasound of more than 3mm. 4. Vein depth of less than 0.5cm from the skin. 5. Normal Allen's test indicating that ulnar artery flow to the hand is sufficient. 6. No calcification in the wall of the distal radial artery. 7. Sufficient length of the proposed fistula outflow vein to provide an adequate (at least 6 cm) cannulation segment. 8. No evidence of iatrogenic injury to target artery or vein. 2. Uncontrolled diabetes; a. HbA1c \>10% (at Screening). 3. History or evidence of severe peripheral arterial disease in the extremity selected for implant. 4. Known or suspected central vein stenosis or obstruction on the side of planned SA creation, unless corrected prior to randomization. 5. Planned AVF creation that requires more than one stage to complete. (e.g. basilic vein transposition AVF performed in 2 stages). 6. Planned AVF creation by means other than suture or vascular anastomotic clips (e.g. endovascular surgery or other anastomotic creation devices). 7. Treatment with any investigational drug or device within 60 days prior to study entry (Day 0) or ongoing participation in a clinical trial of an investigational product. 8. Cancer that is actively being treated with a cytotoxic agent. 9. Documented hyper-coagulable state. 10. Bleeding diathesis. 11. Active clinically significant immune-mediated disease, not controlled by maintenance immunosuppression. 1. Low dose glucocorticoid therapy (e.g. 5-10mg prednisone \[Deltason\]) is acceptable. 2. High dose glucocorticoid therapy for treatment of autoimmune flare, or other inflammatory diseases is excluded. 3. Patients using glucocorticoids for immunosuppression post-transplant to prevent against transplanted allograft rejection in the period post allograft failure are excluded. 4. The following examples of immunosuppressive agents (or the like) are exclusionary for enrollment in this clinical trial: * tacrolimus or FK506 \[Prograf\] * mycophenolate mofetil \[Cellcept\], * cyclosporine \[Sandimmune or Gengraf\] * sirolimus \[Rapamune\] (this only includes systemically administered, drug eluting stents are acceptable) 12. Anticipated renal transplant within 6 months. 13. History of heparin-induced thrombocytopenia. 14. Venous outflow from SA cannot be located more centrally than the venous outflow of any previous failed access in that extremity. 15. Active local or systemic infection (white blood cells \[WBC\] \> 15,000 cells/mm3 at Screening). If the infection resolves, the subject must be at least one week post resolution of that infection before SA creation. 16. Known serious allergy or intolerance to aspirin and alternative antiplatelet therapy. 17. Pregnant women, or women intending to become pregnant during the course of the trial. 18. Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the SA. 19. Previous enrollment in this study or any other study with HAV. 20. Employees of Humacyte and employees or relatives of an investigator.

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Conditions

The condition(s) this trial relates to.

chronic kidney disease end stage renal failure kidney failure

As listed by the trial registrant

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

End-stage renal disease Hemodialysis Renal failure Vascular access

Contacts and locations

Locations

  • Alliance Research

    Laguna Hills, California, 92653, United States

  • Arizona Kidney Disease and Hypertension Center (AKDHC)

    Phoenix, Arizona, 85012, United States

  • Balboa Nephrology

    San Diego, California, 92123, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Coastal Vascular & Interventional, PLLC

    Pensacola, Florida, 32503, United States

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526, United States

  • Denver Health Medical Center

    Denver, Colorado, 80204, United States

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303, United States

  • Huntington Hospital

    Pasadena, California, 91105, United States

  • Kaiser Permanente Sunnsyide

    Portland, Oregon, 97015, United States

  • Kidney Care & Transplant Services of New England

    West Springfield, Massachusetts, 01089, United States

  • Memorial Healthcare System

    Pembroke Pines, Florida, 33021, United States

  • Mills Peninsula Hospital

    San Mateo, California, 94401, United States

  • Olive View- UCLA Medical Center

    Sylmar, California, 91342, United States

  • Overlook Medical Center

    Summit, New Jersey, 07901, United States

  • Rutgers University

    Newark, New Jersey, 07103, United States

  • South Plains Surgery Center

    Lubbock, Texas, 79416, United States

  • Surgical Specialists of Charlotte

    Charlotte, North Carolina, 28207, United States

  • Tampa General Hospital

    Tampa, Florida, 33606, United States

  • The Regional Medical Center

    Orangeburg, South Carolina, 29118, United States

  • The Vascular Experts

    Darien, Connecticut, 06820, United States

  • UC Davis

    Sacramento, California, 95817, United States

  • United Surgical Associates

    Lexington, Kentucky, 40504, United States

  • University of Arizona

    Tucson, Arizona, 85724, United States

  • University of CA, San Diego - LaJolla VA Hospital

    La Jolla, California, 92161, United States

  • University of California San Diego, Jacobs Medical Center

    La Jolla, California, 92103, United States

  • University of California, Irvine

    Irvine, California, 92868, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • University of Tennessee Knoxville

    Knoxville, Tennessee, 37920, United States

  • VA Long Beach Healthcare System

    Long Beach, California, 90822, United States

  • VA Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

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