Lab-Made blood vessel could free dialysis patients from catheters

NCT ID NCT05908084

Ongoing 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.

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

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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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