Biotech firm Humacyte Inc. today highlighted results from its CLN‑PRO‑V007 pivotal Phase 3 trial, reporting that its acellular tissue engineered vessel (ATEV™) outperformed traditional arteriovenous fistulas (AVF) in high‑risk patients with end‑stage renal disease (ESRD).
The randomized, two‑arm, multicentre trial enrolled 242 ESRD patients on hemodialysis, including 110 deemed high‑risk—defined as women or individuals with BMI ≥ 30 kg/m² and diabetes. ATEV recipients demonstrated superior functional patency and usability compared to AVF controls, with comparable rates of access‑related complications and infections.
Although thrombosis and stenosis events were more frequent in the ATEV group, most were resolved successfully, and patients required fewer maturation and surgical revisions. Earlier summaries from Kidney Week 2024 reveal that at six months, the ATEV cohort achieved patency of 81.3 % versus 66.4 %, and 68.3 % versus 62.2 % at 12 months; the combined superiority test had a p‑value of .0071.
“We believe that the efficacy and safety results…in the subgroup, combined with the ~50 % failure rate of standard of care in this group, point to the potential of the ATEV in this patient population,” Humacyte President and CEO Dr Laura Niklason said. “We look forward to publication of the results…in the near‑term.” The serum‑science CEO added that the presentation was one of only three specially mentioned by the Society for Vascular Surgery.
The data was delivered during a plenary session at the Society for Vascular Surgery’s annual meeting (VAM25) on June 6, 2025, by Dr Mohamad A. Hussain of Brigham and Women’s Hospital and Harvard Medical School.
Humacyte clarifies that outside of the FDA‑approved extremity vascular trauma indication, the ATEV remains investigational and has not been approved for sale.
