Bioengineered Vessel for Dialysis Access Integrates With Patient Cells

The acellular tissue engineered vessel (ATEV) is built in a bioreactor from human cells that are later removed, leaving a collagen conduit that can be implanted between an artery and a vein for hemodialysis access.

Prabir Roy-Chaudhury, MD, PhD, FASN, co-director of the University of North Carolina (UNC) Kidney Center at the UNC at Chapel Hill School of Medicine, shared interim phase 3 V012 results in women at the American Society of Nephrology (ASN) Kidney Week 2026 in Denver, Colorado, and discussed the vessel’s design and future research in an interview with HCPLive. In V012, women with end-stage kidney disease (ESKD) who received the ATEV had a mean of 91 more catheter-free days over 12 months than those who received an arteriovenous fistula (AVF).¹

How the Acellular Tissue Engineered Vessel Is Manufactured

Vascular access has seen little innovation since the first AVF was placed more than 60 years ago, Roy-Chaudhury noted, and he said the ATEV’s biology is what sets it apart.

Production begins with a scaffold shaped like a vascular graft, he explained. The scaffold is seeded with cells that proliferate and produce extracellular matrix components in a bioreactor.

Because those cells could trigger an alloimmune reaction in a recipient with a different human leukocyte antigen (HLA) phenotype, they are then removed. What remains is a collagen tube that he described as tough and flexible enough to be stretched, pulled, and punctured with needles.

ATEV Integrates With Recipient Cells After Implantation

“If you take one of these vessels out at, say, a year, it’s really like a living, breathing vessel,” Roy-Chaudhury said.

Once the ATEV is implanted, cells from the patient begin to grow into the vessel after about 4 to 8 weeks, he explained. At a year, the vessel contains smooth muscle cells and fibroblasts, with endothelial cells lining its interior.

The ATEV was approved by the US Food and Drug Administration (FDA) as Symvess for extremity vascular trauma in December 2024 and remains investigational for hemodialysis access. Humacyte has said the V012 results will support a planned supplemental biologics license application to expand the label.²

Earlier Cannulation and Cost Analysis Among Next Steps for ATEV Research

The ATEV has traditionally been cannulated after 4 weeks, Roy-Chaudhury noted, and he identified earlier cannulation as a key area for future research.

“If you could actually cannulate it at one week, and this is research that I think needs to be done, then I think that would be amazing, because now you’re into the territory of maybe avoiding a catheter completely,” he said.

He also called for a detailed health economic analysis comparing overall costs between the ATEV and AVF over a longer period, such as 2 years, including the cost of interventions in each group.

Moving Vascular Access Toward Precision Medicine

Beyond the ATEV itself, Roy-Chaudhury said the field needs more industry investment and new devices so that patients have choices. With multiple options available, he said, clinicians could match each patient to the device or drug most likely to work for them.

“I think we really need to get vascular access into a precision medicine mode, and I do think that this study is pushing us in that direction,” he said.

Editors’ Note: Disclosures for Roy-Chaudhury include Adgero, Alexion, AstraZeneca, Bayer, Becton Dickinson, BioMed Organ Bank, Boston Scientific, CorMedix, Cylerus, Eko, Humacyte, Inovasc, Merit Medical, Mozarc, Panoramic Health, Sojourn, and Vera Therapeutics. The V012 trial is funded by Humacyte.

References

1. Hussain MA, Roy-Chaudhury P, Bou-Ghannam S, et al. Randomized controlled trial of an acellular tissue engineered vessel vs. arteriovenous fistula for hemodialysis access in female patients with ESKD: a phase 3 CLN-PRO-V012 interim analysis. Abstract presented at: American Society of Nephrology Kidney Week 2026; October 21–25, 2026; Denver, CO. Abstract TH-OR113. doi:10.1681/ASN.2026q87550d8

2. Humacyte. Humacyte at ASN Kidney Week: phase 3 trial built for women shows ATEV advantage over fistula, getting patients off catheters months sooner. GlobeNewswire. Published October 23, 2026. Accessed October 27, 2026. https://capital.com/en-gb/news/humacyte-at-asn-kidney-week-phase-3-trial-built-for