Abstract: SA-OR026
Two-Year Outcomes from a Prospective Randomized Trial of Humacyte's Acellular Tissue Engineered Vessel vs. Autologous Arteriovenous Fistula for Hemodialysis Access
Session Information
- Dialysis Vascular Access: From Basic Discovery to Translational Science
November 08, 2025 | Location: Room 342D, Convention Center
Abstract Time: 05:40 PM - 05:50 PM
Category: Dialysis
- 803 Dialysis: Vascular Access
Authors
- Hussain, Mohamad Anas, Brigham and Women's Hospital, Boston, Massachusetts, United States
- Moore, Ernest E, Denver Health, Denver, Colorado, United States
- Khondker, Zakaria, Humacyte Global Inc, Durham, North Carolina, United States
- Parikh, Shamik J, Humacyte Global Inc, Durham, North Carolina, United States
- Niklason, Laura E., Humacyte Global Inc, Durham, North Carolina, United States
Background
Autologous arteriovenous fistulas (AVFs) are the standard for initial vascular access in patients requiring hemodialysis (HD), yet AVF maturation failure remains a significant clinical challenge. Humacyte’s Acellular Tissue Engineered Vessel (ATEV), a bioengineered human tissue conduit, may offer durable access with reduced complications. This analysis presents extended two-year longitudinal outcomes comparing ATEV and AVF in HD patients from the CLN-PRO-V007 trial.
Methods
In this phase 3, prospective, multicenter, randomized controlled trial (N=242), patients requiring surgical vascular access for HD were randomized to receive either ATEV or autologous AVF. The 24-month analysis evaluates Kaplan-Meier estimated time to secondary patency loss (access abandonment), duration of access use, rate of access-related infections, clinically significant aneurysms or pseudoaneurysms, and overall frequency and severity of adverse events.
Results
Mean participant age was 58.6 years; 29% were female. At 24 months, ATEV recipients demonstrated numerically longer duration of study access use than with AVF (13.6 vs 12.5 months). As of December 2024, 12-month secondary patency was maintained in 68.3% of ATEV recipients, and 62.2% of AVF recipients; for females and obese, diabetic males, a sub-group at high-risk of AVF maturation failure, this result was 76.8% (ATEV) and 46.3% (AVF). Clinically significant pseudoaneurysms were observed less frequently in the AVF group (3.3% vs 14.9% ATEV), though aneurysm rates were equivalent (1.7% in AVF and ATEV). Study access-related infections were low in both groups: 7.4% ATEV vs 5.8% AVF patients. Access rupture was reported in 0 patients in ATEV and 2 patients in AVF group. The overall frequency of serious adverse events was similar between groups when adjusted for duration of access use, with no unexpected safety signals.
Conclusion
ATEV demonstrated numerically longer duration of access use at 24 months, and a greater proportion maintained secondary patency at 12 months, with overall comparable safety relative to AVFs. These results support ATEV as a durable and clinically viable alternative for long-term HD access, particularly in patients at risk for AVF maturation failure. (CLN-PRO-V007; ClinicalTrials.gov, NCT03183245)
Funding
- Commercial Support – Humacyte Global, Inc