Humacyte Completes Enrollment in Phase 3 Trial of Human Acellular Vessel™ (HAV™) for Hemodialysis Access in End-Stage Renal Disease Patients

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[{"type":"text","content":"DURHAM, N.C., April 11, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today 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 (HAV) in establishing vascular access for hemodialysis patients with end-stage renal disease (ESRD) as compared to autogenous arteriovenous (AV) 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. Enrolled individuals were randomly assigned to either the ​​HAV, or an AV fistula for hemodialysis. Efficacy assessments include useability of the conduit for dialysis at six and 12 months and a comparison of secondary patency, evaluated at 12 months. The rate of dialysis-related infections in both HAV and fistula subjects will also be tracked as a secondary endpoint. “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.” Nearly 786,000 Americans are currently living with ESRD, a disease that develops when chronic kidney disease progresses to a point where either dialysis or a kidney transplant is required for survival. Dialysis treatments require establishing a durable point of access to a patient’s circulatory system, in order to transfer the large volume of blood that must be transported to the dialysis machine and then back into the patient. However, the current standard of care for establishing vascular access has significant risks and shortcomings. Catheters, which are tunneled underneath the skin, have high rates of bloodstream infection, while autogenous AV fistulas exhibit a high rate of early maturat...

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