NEW ORLEANS, LA, JUNE 6, 2025 – Findings from a phase three, randomized controlled clinical trial demonstrate the superiority of Humacyte’s Acellular Tissue Engineered Vessel (ATEV) over autologous arteriovenous fistula (AVF) in high-risk patients with end-stage kidney disease (ESKD). These data highlight the potential of ATEV to address unmet needs in patients with complex clinical profiles. Findings were presented today as an oral abstract during the Society for Vascular Surgery’s Vascular Annual Meeting, VAM25.
ESKD is the final stage of chronic kidney disease (CKD), with only 15% or less of the kidney functioning in filtration.[1] A decrease in filtration can lead to a wide range of complications, such as hypertension, anemia, malnutrition, bone disease, neuropathy, and decreased quality of life.[2] ESKD impacts more than 800,000 people in the United States, with 68% on dialysis and 32% with a kidney transplant.[3] Hemodialysis (HD), or the use of a machine to filter the blood, is one option for dialysis. AVF, a surgical procedure that connects an artery to a vein, is the preferred method for vascular access in hemodialysis patients because, when successful, it reduces long-term catheter use and associated complications. However, women and patients with obesity and diabetes are at higher risk of AVF maturation failure, meaning the fistula doesn’t develop adequately for use in dialysis, often resulting in prolonged catheter dependence and increased morbidity.
CLN-PRO-V007 is a prospective, multicenter, two-arm, randomized controlled trial comparing the efficacy and safety of ATEV and AVF in ESKD patients on HD undergoing single-stage surgical vascular access creation. ATEVs are bioengineered blood vessels grown from human vascular cells, designed to restore, replace, or enhance the function of damaged or diseased vascular tissue.
The V007 clinical trial enrolled a total of 242 ESKD patients, of which 110 were specified as high-risk of fistula non-maturation. High-risk ESKD patients were defined as females and males with a body mass index (BMI) ≥ 30kg/m2 and having diabetes. Among this cohort, functional patency at six months and secondary patency at 12 months were significantly higher in ATEV recipients (85.7% and 76.8%, respectively), compared with AVF (51.9% and 46.3%, respectively) (global p-value, p<0.0001). Duration of access usability over the first year was higher in the ATEV group (8.0 months vs. 4.5 months; p<0.0002). These results were consistent across individual subgroups of female patients and male patients with BMI ≥ 30 kg/m2 and diabetes. ATEV provides better functional patency, usability, and a comparable access-related complication profile to AVFs in high-risk subgroups of ESKD patients, providing patients with a safe, durable option, with low infection rates.
“Often, we see patients who are considered high-risk and in end-stage kidney failure needing multiple interventions and autologous arteriovenous fistulas often failing,” said Mohamad A. Hussain, MD, PhD, Vascular and Endovascular Surgeon and Assistant Professor of Surgery from Brigham and Women’s Hospital, Harvard Medical School and lead author of the study. “Acellular Tissue Engineered Vessels are a new and exciting technology in regenerative medicine that has the potential to make a great impact in how we treat a vulnerable population.”
Authors note, a currently enrolling randomized control study is looking specifically at high-risk ESKD female patients across multiple centers in the U.S. who receive ATEV or AVFs to further analyze the effectiveness specifically in the female population. For uses other than FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
Session Details:
“Plenary Session 6: Acellular Tissue Engineered Vessel Outperforms Arteriovenous Fistula in High-Risk Patients on Hemodialysis: Results from the CLN-PRO-V007 Randomized Controlled Trial” [Friday, June 6, 2025 at 10:00 am CT]
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About the Society for Vascular Surgery
The Society for Vascular Surgery® (SVS) seeks to advance excellence and innovation in vascular health through education, advocacy, research, and public awareness. The organization was founded in 1946 and currently has a membership of approximately 6,500. SVS membership is recognized in the vascular community as a mark of professional achievement.
About VAM25
The Society for Vascular Surgery’s annual VAM meeting will be held in New Orleans, LA, on June 4-7. Leading physicians, researchers, and health care professionals in vascular surgery gather for three full days of groundbreaking educational content showcasing the latest data, research, and innovations in vascular surgery and vascular health. For more information, visit Vascular.org.
Press Contact:
Bethany Grassley
bgrassley@brgcommunications.com
703-739-834
[1] Imamah NF, Lin HR. Palliative Care in Patients with End-Stage Renal Disease: A Meta Synthesis. Int J Environ Res Public Health. 2021 Oct 11;18(20):10651. doi: 10.3390/ijerph182010651. PMID: 34682395; PMCID: PMC8535479.
[2] Levey A.S., Coresh J., Balk E., Kausz A.T., Levin A., Steffes M.W., Hogg R.J., Perrone R.D., Lau J., Eknoyan G. National Kidney Foundation practice guidelines for chronic kidney disease: Evaluation, classification, and stratification. Ann. Intern. Med. 2003;139:137–147. doi: 10.7326/0003-4819-139-2-200307150-00013. [DOI] [PubMed] [Google Scholar]
[3] United States Renal Data System. 2023 USRDS Annual Data Report: Epidemiology of kidney disease in the United States. National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2023.