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

Prabir Roy-Chaudhury, MD, PhD.

, who face lower fistula maturation rates than men, an acellular tissue engineered vessel (ATEV) significantly increased catheter-free days over 12 months compared with an arteriovenous fistula (AVF) in the randomized phase 3 V012 trial.¹

American Society of Nephrology (ASN) Kidney Week 2026

 in Denver, Colorado, by 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, the interim data show women who received the ATEV reached functional access months sooner and had fewer dialysis access-related infections. Investigators concluded the findings support the ATEV as a potential first-line option for women at increased risk of AVF maturation failure.

Bioengineered Vessel Adds 91 Catheter-Free Days for Women on Dialysis

“Vascular access really is currently both the lifeline for patients on hemodialysis, but it’s also the Achilles heel,” Roy-Chaudhury said in an interview with 

. “If you place 100 arteriovenous fistulae, you’re only going to get about 40 or 45 of them that will work well to support dialysis without intervention.”

AVFs are the preferred access for hemodialysis, but delayed or failed maturation often prolongs central venous catheter use.¹ Catheters carry well-documented risks, including bloodstream infection, thrombosis, and central venous stenosis.² Women experience lower AVF maturation and greater catheter dependence than men, which contributes to morbidity in this population.¹

Catheter Dependence in Women Drove the V012 Trial

Roy-Chaudhury put infection at the top of that list, summarizing the complications of prolonged tunneled catheter use as “number one infection, number two infection, number three infection.”

He noted that vascular access research has not previously studied women as a high-risk group. Investigators described V012 as the first randomized evaluation of a vascular access conduit in this population.¹

V012 Randomized Women With ESKD to ATEV or AVF

V012 is a prospective, multicenter, randomized phase 3 trial enrolling women with ESKD who were receiving hemodialysis via catheter and were eligible for AVF creation. Patients were randomized in a 1:1 ratio to receive an ATEV or an AVF.¹

The primary endpoint was catheter-free days through 12 months. Investigators performed a prespecified interim superiority analysis after 80 patients, 40 in each group, completed 12 months of follow-up.¹

ATEV Increased Catheter-Free Days and Shortened Time to Maturation

The ATEV met the primary endpoint, with a mean of 220 catheter-free days over 12 months vs 129 days with AVF (difference, 91 days; 95% CI, 40–142; 

 < .001). At 6 months, the ATEV group had 52 additional catheter-free days (

Functional patency over 12 months was greater with the ATEV (250 vs 152 days; 

 < .001), and mean time to maturation was 1.7 months vs 5.3 months with AVF. Secondary patency was greater with the ATEV at 6 months (88% vs 65%; P = .02). At 12 months, it was 78% vs 63%, a difference that was not statistically significant (P = .16).¹

Thrombosis, Stenosis, and Infection Outcomes With ATEV

Dialysis access-related infections, including catheter infections, occurred in 15% of patients in the AVF group vs 5.1% in the ATEV group. No study access-related infections occurred in either group. True or pseudoaneurysm and steal syndrome were infrequent, and no study access ruptures were observed.¹

Thrombosis and stenosis events were more frequent with the ATEV (20 and 43 events vs 8 and 36 with AVF, respectively). However, the usage-adjusted stenosis rate was lower with the ATEV, at 162 vs 229 per 100 patient-years.¹

Roy-Chaudhury explained that because ATEVs matured faster, they were in use for about 3 months longer during the first year, and event rates were more comparable after accounting for that additional time. “But again, I think this is something that needs to be looked at in more detail,” 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. 

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

Lok CE, Huber TS, Lee T, et al. KDOQI clinical practice guideline for vascular access: 2019 update. 

. 2020;75(4 Suppl 2):S1-S164. doi:10.1053/j.ajkd.2019.12.001

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In interim V012 data, women on hemodialysis reached usable access months sooner with ATEV, said Prabir Roy-Chaudhury, MD, PhD.

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 

 in Denver, Colorado, and discussed the vessel’s design and future research in an interview with 

 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

Bioengineered Vessel for Dialysis Access Integrates With Patient Cells

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.

 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.

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

Prabir Roy-Chaudhury, MD, PhD, explains how the ATEV is made and the research questions he wants answered next.

Prabir Roy-Chaudhury, MD, PhD.

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