Humacyte's acellular tissue engineered vessel (ATEV) has demonstrated superior performance over the current gold standard autogenous fistula in high-risk hemodialysis patients, according to two-year results from the company's Phase 3 V007 trial presented at the American Society of Nephrology's Kidney Week 2025.
The bioengineered vessel showed significantly longer duration of use in female, obese, and diabetic patients—subgroups that historically experience poor outcomes with arteriovenous (AV) fistula procedures. These findings could transform dialysis access strategies for more than half of the hemodialysis population who fall into these high-risk categories.
Superior Outcomes in High-Risk Populations
In the V007 Phase 3 trial involving 242 hemodialysis patients, the ATEV demonstrated clinically meaningful advantages in duration of access use over 24 months. Female patients implanted with the ATEV averaged 15.8 months of usage compared to 10.0 months for those receiving an AV fistula (p<0.0137).
The results were equally compelling in the combined target population of females and males with obesity and diabetes (n=110), where ATEV patients achieved 14.8 months of average duration of access use compared to 9.1 months for AV fistula patients (p=0.0114).
"In the V007 study the ATEV provided a clinically meaningful advantage in early usability and functional patency, enabling faster, more reliable dialysis initiation, especially in female, obese, and diabetic patients," said Dr. Mohamad A. Hussain, Vascular and Endovascular Surgeon-Scientist at Brigham and Women's Hospital and Assistant Professor of Surgery at Harvard Medical School, who presented the findings.
Clinical Impact on Catheter Dependence
The significantly longer duration of ATEV use in high-risk patients could substantially reduce reliance on catheters for dialysis access, addressing a major source of complications, morbidity, and cost in dialysis care. Dr. Hussain emphasized that these positive results in underserved patient groups "could greatly reduce reliance on catheters for arteriovenous access, a major cause of complications and treatment costs in patient care."
For the overall study population (n=242), patients receiving an ATEV had 13.3 months of average duration of access use compared to 12.3 months for AV fistula (p=0.7446), indicating the technology's particular benefit for high-risk subgroups rather than the general population.
Safety Profile and Adverse Events
The two-year follow-up revealed no unexpected side effects in patients implanted with the ATEV. The bioengineered vessel maintained a comparable safety profile to AV fistula, with low infection rates (7.4% in the ATEV group versus 5.8% in the AVF group) and reduced need for maturation or surgical revision procedures.
However, patients with ATEV experienced more thrombosis and stenosis events requiring interventions compared to AV fistula patients. The majority of these cases were successfully treated. Clinically significant pseudoaneurysms occurred more frequently in the ATEV group (14.9%) compared to the AVF group (3.3%), though aneurysm rates were equivalent between groups (1.7% each).
Secondary Patency Outcomes
Extended analysis showed that 68.3% of ATEV patients maintained 12-month secondary patency compared to 62.2% in the AVF group. The difference was more pronounced in high-risk patients, with 76.8% of the ATEV group maintaining 12-month secondary patency versus 46.3% in the AVF group.
Clinical Perspective and Future Implications
Dr. Roy Fujitani, Professor of Vascular and Endovascular Surgery at UC Irvine, described the results as "truly groundbreaking," noting that "seeing the ATEV outperform AV fistulae in high-risk patients—particularly women, diabetics, and those with obesity—is incredibly encouraging."
The V007 Phase 3 trial (NCT03183245) was a prospective, multi-center, randomized clinical study that followed patients for up to 24 months. The primary efficacy assessment compared functional patency at six months and secondary patency at 12 months as co-primary endpoints, both of which the ATEV achieved superiority over autogenous fistula.
Dr. Jason Burgess of Surgical Specialists of Charlotte, who participated in the study, expressed enthusiasm about the clinical potential: "As a clinician who participated in this study, I'm excited by the potential of a bioengineered vessel that not only improves usability but also reduces catheter dependence."
The ATEV has received FDA approval for extremity vascular trauma and holds Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for hemodialysis access applications. For uses other than the FDA-approved vascular trauma indication, the ATEV remains investigational and has not been approved for sale by regulatory agencies.
