Rationale and Trial Design of MesEnchymal Stem Cell Trial in Preventing Venous Stenosis of Hemodialysis Vascular Access Arteriovenous Fistula (MEST AVF Trial)

Abstract

Background Hemodialysis arteriovenous fistulas (AVFs) are the preferred vascular access for patients on hemodialysis. In the Hemodialysis Fistula Maturation Study, 44% of the patients achieved unassisted maturation of their fistula without needing an intervention. Venous neointimal hyperplasia (VNH) and subsequent venous stenosis are responsible for lack of maturation. There are no therapies that can prevent VNH/VS formation. The goal of this paper is to present the background, rationale, and trial design of an innovative phase 1/2 clinical study that is investigating the safety of autologous adipose-derived mesenchymal stem cells delivered locally to the adventitia of newly created upper extremity radiocephalic (RCF) or brachiocephalic fistula (BCF). Methods The rationale and preclinical studies used to obtain a physician-sponsored investigational new drug trial are discussed. The trial design and end points are discussed. Results This is an ongoing trial that will complete this year. Conclusion This is a phase 1/2 single-center, randomized trial that will investigate the safety and efficacy of autologous AMSCs in promoting maturation in new upper-extremity AVFs. Clinical Trial registration number: NCT02808208