Humacyte’s HAV for Hemodialysis Evaluated in 5-Year Data from Phase 2 Trial

February 28, 2022—Humacyte, Inc. announced that 5-year data from a phase 2 clinical trial of patients receiving the company’s investigational human acellular vessel (HAV) for arteriovenous (AV) access in hemodialysis have been published by Professor Tomasz Jakimowicz, MD, et al in the European Journal of Vascular and Endovascular Surgery companion journal EJVES Vascular Forum (2022;54:58-63).

According to Humacyte, the investigators reported the durable long-term use and ongoing clinical function of the HAV in patients with end-stage renal disease who are undergoing hemodialysis. The HAV was observed to provide routine and functional hemodialysis access for patients with end-stage renal disease who require dialysis three times a week.

Prof. Jakimowicz, who is from the Medical University of Warsaw, Poland, and serves as Principal Investigator of the trial, commented in the company’s press release, “Patients with end-stage renal disease require chronic vascular access for hemodialysis, and those who are not candidates for fistulas must rely on synthetic AV grafts, which have a higher rate of complications including an increased risk of infection. I am encouraged by the results from this trial because in addition to retaining structural integrity needed for hemodialysis, the HAV was observed to have a low risk of infection with long-term use. These results indicate the potential of the HAV as a promising option for vascular access in hemodialysis.”

The prospective phase 2 trial evaluated the HAV in 40 adult patients with end-stage renal disease undergoing hemodialysis at three sites in Poland. Of the 40 patients, 29 completed the originally specified 24-month phase 2 trial with patent HAVs and provided consent to be followed for HAV conduit status every 3 months thereafter through at least 5 years.

At month 60, patency allowing for reliable dialysis access cannulation was estimated at 58.2% of evaluable patients (ie, those who completed the original 24-month study with patent HAVs and consented to participate in the long-term follow up) (95% CI, 39.2-73.1%), after censoring for deaths and withdrawals.

Long-term explant samples showed progressive host-cell remodeling of the HAV, including an adventitial layer with neovascularization and recellularized medial layer that were observed in histological imaging, further strengthening the hypothesis that the HAV may regenerate into a living vascular tissue.

Although there was no comparator in this phase 2 trial, historical reports of AV fistula indicate an approximately 30% functional patency of evaluable patients at 5 years. In addition, no infections of the HAV were reported during the 5-year follow-up period, with the HAV being well tolerated and nonimmunogenic.

Humacyte advised that as a follow-up to the phase 2 trial, the company is currently conducting a phase 3 trial in up to 240 dialysis patients. This is a prospective, multicenter, open-label, randomized, two-arm comparative trial designed to assess the usability of the HAV for dialysis at 6 and 12 months as a comparison to autogenous fistulas. As of December 31, 2021, 207 patients had been enrolled in the phase 3 trial.

The HAV is an investigational product candidate and is not currently approved for sale by the FDA or any international regulatory authority, stated the company.