16 May 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).
MedicalResearch.com: What should readers take away from your report?
Dr. Niklason: The rates of primary, primary assisted, and secondary patency were 63%, 73%, and 97%, respectively at 6 months and 28%, 38%, and 89%, at 12 months, with most loss of primary patency due to thrombosis. Pooled (US and Poland) interventions to maintain or restore HAV patency were 1.89 per patient per-year, and there was one HAV infection during 82 patient-years. Human acellular vessels did not show dilatation, had adequate blood flow rates for hemodialysis, and rarely showed post-cannulation bleeding. HAVs repopulated with host cells following implantation and no consistent increase in PRA levels were observed in patients following HAV implantation.
Our interpretation of these findings is that bioengineered human acellular vessels appear to provide safe and functional hemodialysis access, and warrant further study in randomized controlled trials. (ClinicalTrials.gov numbers NCT01744418 and NCT01840956).
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. Niklason: We will be embarking on a pivotal Phase III trial shortly. Depending upon the speed of enrollment and other factors, this trial may be complete in three or four years.
MedicalResearch.com: Is there anything else you would like to add?
Dr. Niklason: I would hope that physicians and non-physicians alike would understand that this is a very exciting development. Being able to engineer human tissues that are available “off-the-shelf” for implantation into patients could be a really significant advance.
If we are able to extend this tissue engineering paradigm to other types of tissues in the future, then this could very much change the way that surgery is practiced.
MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.
Bioengineered human acellular vessels for dialysis access in patients with end-stage renal disease: two phase 2 single-arm trials
Lawson, Jeffrey H et al.
The Lancet , Volume 387 , Issue 10032 , 2026 – 2034
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