Humacyte, Inc. presented Phase 3 clinical trial results of its acellular tissue engineered vessel (ATEV™) compared to autologous arteriovenous (AV) fistulas for hemodialysis access in patients with end-stage renal disease (ESRD) at the VEITH 51st Annual Symposium.
The study, led by Dr. Charles Keith Ozaki from Brigham and Women’s Hospital and Harvard Medical School, evaluated the efficacy and safety of Humacyte's ATEV in this patient population. The ATEV represents a novel approach to creating vascular access for hemodialysis, potentially offering an alternative to traditional autologous AV fistulas.
Study Design and Objectives
The Phase 3 trial compared the performance of the bioengineered vessel against the current gold standard, autologous AV fistulas. The primary endpoints included assessments of vessel patency, functionality, and safety. Secondary endpoints focused on factors such as the need for interventions to maintain patency and overall patient outcomes.
Potential Impact on Hemodialysis Access
Creating and maintaining reliable vascular access remains a significant challenge for patients with ESRD requiring hemodialysis. According to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), approximately 800,000 people in the United States are living with ESRD, most of whom require hemodialysis. Autologous AV fistulas are often preferred, but their creation can be challenging in some patients due to compromised native vessels. The ATEV offers a potential off-the-shelf solution that could expand access options for these individuals.
Regulatory Status and Future Directions
Humacyte's 6mm ATEV for AV access has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA. A Biologics License Application for ATEV in vascular trauma is under FDA review with Priority Review status. Further studies are underway to explore the ATEV's potential in coronary artery bypass grafts, pediatric heart surgery, and the treatment of type 1 diabetes.
