Results from the CLN-PRO-V007 randomized controlled trial of Humacyte’s acellular tissue engineered vessel (ATEV) are set to be shared today during VAM 2025 Plenary 6 (10–11 a.m., First Floor, Great Hall A), showing several clinical benefits when compared to arteriovenous fistula (AVF) in hemodialysis (HD) patients with a high risk of fistula maturation failure.
“ATEV provides better functional patency, usability, and a comparable access-related complication profile to AVFs in high-risk subgroups of ESKD [end-stage kidney disease] patients,” submitting and presenting author Mohamad A. Hussain, MD, vascular and endovascular surgeon and assistant professor of surgery at Brigham and Women’s Hospital and Harvard Medical School in Boston, and colleagues write in their abstract.
The authors write that this key conclusion “makes ATEV a promising alternative to vulnerable populations requiring HD access and highlights its potential to address unmet needs in patients with complex clinical profiles.”
The objective of CLN-PRO-V007—a phase 3, prospective, multicenter, two-arm, randomized controlled trial—was to compare the efficacy and safety of ATEV with autologous AVFs in ESKD patients on HD. Patients were randomized 1:1.
At VAM 2025, Hussain is set to share that functional patency at six months and secondary patency at 12 months were significantly higher in ATEV recipients compared with AVF among 110 high-risk ESKD patients included in the trial out of 242 enrolled in total.
In addition, Hussain will report that duration of access usability over the first year trended higher in the ATEV group, further noting that these results were consistent across individual subgroups of female patients and male patient with a body mass index (BMI) ≥30kg/m2 and diabetes.
With regard to safety, the authors found similar rates of serious adverse events (SAEs) for ATEV patients and AVF patients and comparable infection rates between the two groups.
