Lab-Made blood vessel could free dialysis patients from catheters

NCT ID NCT05908084

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

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tests a lab-grown blood vessel (ATEV) against the standard surgically created fistula in 121 women with end-stage kidney disease who need dialysis. The goal is to see if the ATEV allows more days without a catheter and reduces infections over 12 months. If successful, it could offer a safer, more convenient option for dialysis access.

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 cells that are removed, leaving a collagen tube
What this could lead to: If it works, this could give women on dialysis a better option for blood access, reducing time with catheters and lowering infection risk.
What could go wrong: This is a relatively small Phase 3 trial (121 women). The ATEV may not perform better than the standard fistula, and there are risks of clotting, infection, or vessel failure.

Why investors are watching

Humacyte is testing its lab-grown blood vessel, called ATEV, against the standard surgically built fistula in 121 women with kidney failure who need dialysis. This is a late-stage trial for a very small company, so the outcome could shape whether its product reaches the market and whether the company can grow.

If it works: If the ATEV keeps patients free of catheters longer and causes fewer infections than the standard fistula, Humacyte could have a strong case to seek approval for this use. That would give the company a commercial product in a large patient group.

If it fails: The trial could fail to show that ATEV works as well as or better than the standard fistula, or the company could face delays in completing the study. Trials often fail, and for a micro-cap company, a negative result would leave it without a clear path forward.

AI-written from the trial record. Speculative, and not investment advice.

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

121 people

The number who actually took part.

Started

Sep 2023

Expected to finish

Jun 2028

An estimate. End dates often move.

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

Female participants only

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. Female patients with ESRD, currently receiving hemodialysis via dialysis catheter and who are candidates for the creation of an AVF (see Inclusion Criterion #4 below) or implantation of an ATEV for HD access. 2. Patients who plan to undergo HD at a dialysis unit of a participating dialysis provider for at least 12 months after SA creation. 3. Patients aged ≥ 18 years at Screening. 4. Suitable anatomy for creation of a forearm or upper arm AVF and for implantation of straight, curved, or looped ATEV in either the forearm or upper arm. NOTE: Suitable anatomy will be determined by both physical examination and ultrasound imaging or vessel imaging modality in addition to consideration of all vascular sites available, prior access failure, future access sites and possibilities to preserve patients' future alternate accesses. Vessel mapping is the preferred method to assess the vascular anatomy, and will evaluate the following attributes during Screening: * Vein diameter * Arterial diameter * Presence of arterial calcification * Depth of the intended fistula conduit from the surface of the skin * Central vein patency * Previous vascular access location The ultimate decision of anatomic suitability belongs to the surgeon and/or the investigator. 5. Hemoglobin ≥ 7 g/dL and platelet count ≥ 100,000 /mm3 6. Patients must either: 1. Be of non-childbearing potential, which is defined as post-menopausal (at least 1 year without menses prior to Screening) or documented surgically sterile (i.e., total hysterectomy or tubal ligation, or complete bilateral oophorectomy) at least 1 month prior to Screening. 2. Or, if of childbearing potential: Must have a negative serum pregnancy test at Screening, and Must agree to use at least one form of the following birth control methods for the duration of the study: i. Established use of oral, injectable or implanted hormonal methods of contraception. ii. Placement of an intrauterine device or intrauterine system at least 5 days prior to Screening. iii. Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/ gel/ film/ cream/ suppository. 7. Patient or their legal representative can communicate effectively with investigative staff, is competent and willing to give written informed consent, and able to comply with entire study procedures including all scheduled follow-up visits. 8. Life expectancy of at least 1 year confirmed by Charlson Comorbidity Index ≤ 9. Exclusion Criteria: 1. Male sex at birth. 2. Planned AVF creation by means other than suture or vascular anastomotic clips (e.g., endovascular surgery or other anastomotic creation devices). Venous outflow from study access cannot be located more distally than the venous outflow of any previous failed access in that extremity. 3. Known serious allergy or intolerance to aspirin and alternative antiplatelet therapy. 4. Pregnancy, or women intending to become pregnant during the course of the trial. 5. Treatment with any investigational drug or device within 60 days or 5 half-lives after taking the last dose (whichever is longer) prior to study entry (Day 1) or ongoing participation in a clinical trial of an investigational product. 6. Documented hyper-coagulable state, as defined as either: 1. Documented hyper-coagulable state, as defined as either: A biochemical diagnosis (e.g., Factor V Leiden, Protein C deficiency, etc.) - OR - 2. A clinical history of thrombophilia as diagnosed by 2 or more spontaneous intravascular thrombotic events (e.g., deep vein thrombosis (DVT), pulmonary embolism (PE), etc.) within the previous 5 years. 7. Spontaneous or unexplained bleeding diathesis clinically documented within the last 5 years or a biochemical diagnosis (e.g., von Willebrand's disease, etc.). 8. Cancer actively being treated with a cytotoxic agent. 9. Planned or anticipated renal transplant within 6 months after randomization. 10. Any other condition that in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of the SA. 11. Previous exposure to ATEV. 12. Any of the following within 8 weeks prior to screening: acute coronary syndrome, stroke or congestive heart failure NYHA Stage IV 13. 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

As listed by the trial registrant

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

End-stage renal disease (ESRD)

Contacts and locations

Locations

Access Research Institute

Brooksville, Florida, 34613, United States
Ambulatory Care Pavilion Westchester Medical Center

Valhalla, New York, 10595, United States
American Access Care of Miami, LLC

Miami, Florida, 33156, United States
Boston Medical Center

Boston, Massachusetts, 02118, United States
Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States
Capital Health Medical Center- Hopewell

Pennington, New Jersey, 08534, United States
Cataract & Surgery Center Lubbock

Lubbock, Texas, 79410, United States
Dell Seton Medical Center at The University of Texas at Austin

Austin, Texas, 78701, United States
Denver Health and Hospital Authority

Denver, Colorado, 80204, United States
Dr. Ruben Villa__Nephrology

Lubbock, Texas, 79407, United States
Duke Regional Hospital

Durham, North Carolina, 27704, United States
El Centro Regional Medical Center

El Centro, California, 92243, United States
Georgia Nephrology

Atlanta, Georgia, 30046, United States
Grady Memorial Hospital

Atlanta, Georgia, 30303, United States
Honor Health Scottsdale Shea Medical Center

Scottsdale, Arizona, 85260, United States
IU Health Bloomington Hospital

Bloomington, Indiana, 47408, United States
Jacob's Medical Center at UC San Diego Health

La Jolla, California, 92037, United States
John Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States
Mayo Clinic Florida

Jacksonville, Florida, 32224, United States
New York-Presbyterian Queens_The Lang Center for Research & Education

Flushing, New York, 11355, United States
Rutgers University_Medical

Newark, New Jersey, 07103, United States
San Antonio Vascular and Endovascular Clinic PLLC

San Antonio, Texas, 78221, United States
St.Joseph's University Medical Center

Paterson, New Jersey, 07503, United States
Surgical Specialists of Charlotte

Charlotte, North Carolina, 28207, United States
Temple University

Philadelphia, Pennsylvania, 19140, United States
The San Antonio Vascular and Endovascular Clinic

San Antonio, Texas, 78221, United States
USF Health South Tampa

Tampa, Florida, 33606, United States
University of FL Health Heart and Vascular Hospital

Gainesville, Florida, 32608, United States
University of Michigan

Ann Arbor, Michigan, 48109, United States
University of Tennessee Medical Center

Knoxville, Tennessee, 37920, United States
Wake Forest University School of Medicine_Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States
Yale New Haven Hospital

New Haven, Connecticut, 06519, United States

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