Author Interviews, Kidney Disease / 16.05.2016
Trial Finds Human Acellular Blood Vessels Save and Effective for Dialysis Access
MedicalResearch.com Interview with:
Dr Laura E Niklason, MD PhD
Department of Anesthesia & Biomedical Engineering
Yale University, New Haven, CT
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Niklason: For end stage renal disease patients who are not candidates for fistula, dialysis access grafts are the best option for chronic hemodialysis. However, polytetrafluoroethylene arteriovenous grafts suffer from high rates of thrombosis, infection and intimal hyperplasia at the venous anastomosis.
We are conducting two, single arm Phase II trials where a novel bioengineered human acellular vessel (HAV) was implanted into the arms of patients for hemodialysis access. Primary endpoints were safety (freedom from immune response/infection, aneurysm, or mechanical failure, and incidence of adverse events), and efficacy as assessed by primary, primary assisted and secondary patencies at 6 months. Secondary endpoints included patency and intervention rates at 12, 18 and 24 months, and changes in panel reactive antibodies following implantation. All patients were followed for at least one year, or had a censoring event.
Human acellular vessels were implanted into 60 patients at 6 centers in the US and Poland. The average duration of follow-up was 16 months (range 12 to 30); all patients have completed at least 12 months of follow-up (or been censored).
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