Humacyte, Inc. (Nasdaq: HUMA) announced positive results from its V007 Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV) for arteriovenous (AV) access in patients with end-stage renal disease (ESRD). The study, presented at the American Society of Nephrology’s (ASN) Kidney Week 2024, demonstrated the ATEV's superiority over autogenous fistula, the current standard of care.
The multi-center, randomized trial (NCT03183245) enrolled 242 hemodialysis patients in the United States, who were randomized to receive either the ATEV or an AV fistula. The co-primary endpoints were functional patency (usability for hemodialysis access) at six months and secondary patency (blood flow through the conduit) at 12 months. At six months, 81.3% of ATEV patients had functional patency compared to 66.4% of AV fistula patients. At 12 months, 68.3% of ATEV patients had secondary patency, compared to 62.2% of AV fistula patients. The joint test for superiority was statistically significant (p=0.0071).
Improved Outcomes in High-Need Subgroups
Notably, the ATEV showed superior function and patency in subgroups that historically experience poor outcomes with AV fistulas, including female, obese (BMI ≥ 30), and diabetic patients.
In female patients (n=70), the ATEV group had significantly higher six-month and one-year patency rates (p<0.0001). They also achieved a significantly longer duration of hemodialysis over 12 months (8.3 months vs. 5.0 months, p=0.0011). Obese patients (n=93) with ATEV implants also demonstrated significantly higher patency rates at six months and one year (p=0.0001), with longer hemodialysis duration (7.7 months vs. 4.5 months, p=0.0020). Similarly, diabetic patients (n=165) showed significantly higher patency rates (p=0.0024) and longer hemodialysis duration (7.4 months vs. 5.5 months, p=0.0155) with the ATEV.
Safety Profile and Adverse Events
Infection rates were low in both groups, with 9.1% of ATEV patients experiencing access-related infections (12 events) compared to 9.9% of AV fistula patients (14 events). Treatment-Emergent Adverse Events (TAEEs) were reported in 98.3% of ATEV patients (1,211 events) and 96.7% of AV fistula patients (828 events). Thrombosis was more frequent in the ATEV group (52.1%, 126 events) compared to the AV fistula group (9.1%, 12 events), but 94% of ATEV patients with thrombosis were successfully treated.
Expert Commentary
“These results show that availability of the ATEV, a biologic conduit, could be game changing in improving arteriovenous access in many hemodialysis patients,” said Mohamad A. Hussain, MD, PhD, RPVI, FAHA, FRCSC, FACS, Vascular and Endovascular Surgeon-Scientist at Brigham and Women’s Hospital. He highlighted the positive results in female, obese, and diabetic patients, noting that the significantly higher duration of access could greatly reduce reliance on catheters.
Future Implications
The ATEV is currently an investigational product and has not been approved for sale by the FDA or any other regulatory agency. Humacyte is also pursuing other vascular applications for the ATEV, including vascular trauma repair and peripheral artery disease. A Biologics License Application for the ATEV in vascular trauma is under FDA Priority Review.
