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Lab-Grown vessels could revolutionize dialysis access

NCT ID NCT02644941

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This trial is testing whether a lab-grown human blood vessel (called a Human Acellular Vessel) can serve as a better connection point for hemodialysis than the standard synthetic grafts. People with end-stage kidney disease who need dialysis often require a reliable access point in their arm. The study compares how long the lab-grown vessel stays usable without needing repairs or replacement, compared to the synthetic ePTFE graft. If the lab-grown vessel proves more durable, it could mean fewer complications and surgeries for people on dialysis.

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), a lab-grown biological tube made from human cells, compared to standard synthetic ePTFE grafts.
What this could lead to
If successful, this could provide a more durable and infection-resistant option for dialysis access, reducing the need for repeat surgeries.
What could go wrong
The trial is still in phase 3, and results may not show a clear benefit. There are risks of clotting, infection, or the vessel failing over time.

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

355 people

The number who actually took part.

Started

May 2016

Finished

Sep 2023

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: * Subjects with ESRD who need placement of an AV graft in the arm. * Either on hemodialysis or expected to start hemodialysis within 12 weeks of study conduit implantation. * Suitable anatomy for implantation of straight or looped conduits in either the forearm or upper arm (not crossing the elbow). * Hemoglobin ≥8 g/dL and platelet count ≥100,000 cells/mm3 prior to Day 0 (within 35 days). * Other hematological and biochemical parameters within a range consistent with ESRD prior to Day 0 (within 35 days). * Adequate liver function prior to Day 0 (within 35 days). * Female subjects must be either: * Of non-childbearing potential Or * Must agree to use at least one form of birth control methods for the duration of the study. * 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. * Life expectancy of at least 1 year. Exclusion Criteria: * History or evidence of severe peripheral vascular disease in the intended arm for implantation. * Known or suspected central vein stenosis or conduit occlusion on the ipsilateral side of planned implantation, unless the stenosis is corrected prior to study conduit implantation. * Treatment with any investigational drug or device within 60 days prior to study entry (Day 0). * Cancer that is actively being treated with a cytotoxic agent. * Documented hyper-coagulable state. * Bleeding diathesis. * Active clinically significant immune-mediated disease, not controlled by maintenance immunosuppression. * High dose glucocorticoid therapy for treatment of autoimmune flare, or other inflammatory diseases is excluded. * Patients using glucocorticoids for immunosuppression post-transplant to prevent against transplanted allograft rejection in the period post allograft failure are excluded. * 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 \[Sandimmune or Gengraf\] i-Sirolimus administered systemically (Sirolimus in drug eluting stents is NOT an exclusion) * Anticipated renal transplant within 6 months. * Venous outflow from study conduit cannot be placed more centrally than the venous outflow of any previous failed access in that extremity. * 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 implantation. * Known serious allergy to planned antiplatelet agent. * Pregnant women, or women intending to become pregnant during the course of the trial. * Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the study conduit. * Previous enrollment in this study or any other study with the HAV. * Employees of Humacyte and employees or relatives of the 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

  • Arizona Kidney Disease and Hypertension Center (AKDHC)

    Phoenix, Arizona, 85012, United States

  • Balboa Nephrology

    San Diego, California, 92123, United States

  • Baylor Scott and White Research Institute

    Dallas, Texas, 75226, United States

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

  • Carondelet St. Mary's Hospital

    Tucson, Arizona, 85745, United States

  • Duke University Hospital

    Durham, North Carolina, 27705, United States

  • General Surgery and Vascular Access

    Fresno, California, 93720, United States

  • Greenwood Leflore Hospital

    Greenwood, Mississippi, 38930, United States

  • Grupo de Estudos Vasculares

    Porto, 4050-190, Portugal

  • Guy´s Hospital, Kings´College London

    London, Greater London, SE1 9RT, United Kingdom

  • Hillel Jaffe Medical Center

    Hadera, 38100, Israel

  • Kaiser Permanente

    Portland, Oregon, 97201, United States

  • Ladenheim Dialysis Access Center

    Fresno, California, 93710, United States

  • Leeds General Infirmary

    Leeds, LS1 3EX, United Kingdom

  • Leicester General Hospital

    Leicester, East Midlands/ Leicestershire, LE5 4PW, United Kingdom

  • Medical University of South Carolina (MUSC)

    Orangeburg, South Carolina, 29118, United States

  • Michigan Cardiovascular Institute

    Flint, Michigan, 48507, United States

  • Queen Elizabeth Hospital Birmingham

    Birmingham, West Midlands, B15 2TH, United Kingdom

  • Queen Elizabeth University Hospital Glasgow

    Glasgow, G51 4TF, United Kingdom

  • Rambam Health Care Campus

    Haifa, Haifa District, 3109601, Israel

  • Rutgers-New Jersey Medical School

    Newark, New Jersey, 07103, United States

  • Samodzielny Publiczyn Centralny Szpital Klinziczny w Warszawie - Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego

    Warsaw, 02-097, Poland

  • Sharee Zedek Medical Center

    Jerusalem, 9103102, Israel

  • Southwest Vascular Access Center

    Alsip, Illinois, 60803, United States

  • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego

    Poznan, 61-848, Poland

  • The Cardiovascular Care Group

    Westfield, New Jersey, 07090, United States

  • The Chaim Sheba Medical Center

    Ramat Gan, Tel Aviv, 52621, Israel

  • University of California Irvine (UCI) Medical Center

    Irvine, California, 92868, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • University of South Florida

    Tampa, Florida, 33606, United States

  • University of Wisconsin

    Madison, Wisconsin, 53706, United States

  • Universitätsklinikmn Erlangen, Gefäßchirurgie - Chirurgisches Zentrum

    Erlangen, Bavaria, 91054, Germany

  • Universitätsklinikum Frankfurt Klinik für Gefäß- und Endovascular-Chirurgie

    Frankfurt am Main, Hesse, 60590, Germany

  • VA Long Beach Healthcare System

    Long Beach, California, 90822, United States

  • VA Sacramento Medical Center

    Mather, California, 95655, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Wojewódzki Szpital Specjalistyczny we Wrocławiu

    Wroclaw, 51-124, Poland

  • Yitzhak Shamir Medical Center - Assaf Harofeh

    Tzrifin, 70300, Israel

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