Humacyte’s V007 Trial of HAV for Hemodialysis Access Completes Enrollment

April 11, 2023—Humacyte, Inc. announced it has completed enrollment of the phase 3 V007 trial. The trial is designed to assess the efficacy and safety of the company’s Human Acellular Vessel (HAV) in establishing vascular access for hemodialysis patients with end-stage renal disease (ESRD) as compared to autogenous arteriovenous (AV) fistulas.

According to the company, V007 is a prospective, multicenter, randomized, comparative study in 240 hemodialysis patients with ESRD in the United States. Patients enrolled in the study were randomly assigned to either the HAV or an AV fistula for hemodialysis.

Efficacy assessments include useability of the conduit for dialysis at 6 and 12 months and a comparison of secondary patency evaluated at 12 months. The rate of dialysis-related infections in both HAV and fistula patients will also be tracked as a secondary endpoint.

As noted in the press release, Humacyte’s HAV is a universally implantable, durable tissue-engineered vascular conduit that is designed to be highly resistant to infection and, over time, has been observed to combine with a patient’s own cells to create a living blood vessel. Utilized for AV access, the HAV has the potential to be usable for dialysis more rapidly after implantation, and result in reduced time on catheters which pose an infection risk for patients versus an AV fistula procedure, stated the company.

V007 trial investigator John Lane, MD, a vascular surgeon at Veteren Affairs (VA) San Diego in San Diego, California, commented in the company press release, “My experience with the use of the HAV in our VA population has been very positive thus far. Being involved with the clinical trial has allowed us to provide patients with the latest and greatest in technology, and hopefully gives a window into what will be in the future for hemodialysis access.”

The company advised that the phase 3 V007 trial builds on Humacyte’s series of clinical trials designed to support the use of the HAV technology to expand hemodialysis treatment options. The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

“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.”