Humacyte, a biotech company focused on bioengineered human tissues, presented positive Phase 3 clinical trial results for their acellular tissue engineered vessel (ATEV) at the Society for Vascular Surgery’s Vascular Annual Meeting. The trial, CLN-PRO-V007, demonstrated the ATEV’s efficacy in patients at high risk of arteriovenous fistula (AVF) failure, specifically women and individuals with obesity and diabetes undergoing hemodialysis. The ATEV showed improved functional patency and usability compared to standard AVF procedures in this high-risk group.
This news is particularly relevant because AVF failure is a significant issue for hemodialysis patients, often leading to catheter dependence and associated complications. Women and patients with obesity and diabetes constitute a substantial portion of the dialysis patient population and experience disproportionately high AVF failure rates. The ATEV offers a potential solution for these individuals, potentially improving their quality of life and reducing healthcare burdens associated with failed AVFs.
The CLN-PRO-V007 trial was a randomized controlled study involving 242 end-stage kidney disease patients, with 110 classified as high-risk for AVF failure. While the ATEV group experienced more thrombosis and stenosis events, the majority were successfully treated. Importantly, the ATEV demonstrated comparable safety to AVF, with similarly low infection rates and a reduced need for maturation and revision procedures.
These findings suggest a promising future for the ATEV in addressing the unmet need for reliable vascular access in high-risk hemodialysis patients. The positive results could lead to wider adoption of the ATEV, changing the standard of care and improving outcomes for a significant segment of the dialysis population. Further research and peer-reviewed publication of the full trial results are expected to solidify the ATEV’s position in this field.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
