Humacyte completes enrollment in Phase 3 trial of HAV for hemodialysis

Humacyte announced it has completed enrollment of a Phase 3 trial in hemodialysis access. The "V007 Trial" is designed to assess the efficacy and safety of the Human Acellular Vessel in establishing vascular access for hemodialysis patients with end-stage renal disease as compared to autogenous arteriovenous fistulas. The Phase 3 trial, labeled V007, is a prospective, multi-center, randomized, comparative study in 240 hemodialysis patients suffering from ESRD in the United States. "Completing enrollment in this Phase 3 trial brings us one step closer to our goal of providing vascular access for dialysis patients that is usable more quickly after implant and reduces reliance on catheters, compared to AV fistula procedures," said Shamik Parikh MD, Chief Medical Officer at Humacyte. "We believe our regenerative medicine technology has the potential to transform the quality of care nephrologists are able to provide to their patients, and address the substantial failure rate and risk of infection associated with the current AV access options for hemodialysis."