Humacyte’s Human Acellular Vessel Evaluated at 6 Years in Patients With PAD

January 24, 2023—Humacyte, Inc. announced the publication of 6-year outcomes in a phase 2 study of the company’s bioengineered Human Acellular Vessel (HAV) as a conduit in patients with symptomatic peripheral artery disease. The study investigators reported an overall secondary patency rate of 60%, estimated by Kaplan Meier analysis, for the phase 2 study at 72 months, including all patients originally enrolled.

As noted in the company's press release, the investigators concluded, “The infection-resistant, off-the-shelf human acellular vessel could provide a durable alternative conduit in the arterial circuit setting, to restore lower-extremity blood supply in patients with peripheral artery disease.”

The findings were published by Piotr Gutowski, MD, et al online ahead of print in the Journal of Vascular Surgery (JVS)—Vascular Science.

According to Humacyte, the study showed no evidence of graft rejection or infection. Additionally, no patients underwent amputation of the affected limb out to 6 years. No patients reported pain at rest or ischemic ulcers on the affected legs.

As noted in the press release, the investigators reported in JVS—Vascular Science, “These data have demonstrated the durability of the HAV and suggest the occurrence of cellular remodeling by the host.”

Dr. Gutowski, who is Chief of Vascular Surgery, General Surgery and Angiology at Pomeranian Medical University in Szczecin, Poland, commented in the company’s press release, “Synthetic grafts can be limited due to poorly matched mechanical compliance, risk of infection, and variable patency rates. Furthermore, cryopreserved allogenic grafts are limited due to poor durability, thrombosis, and mechanical degradation. The HAV is designed to be consistent in size, durable in high-pressure circulation, show no clinical immunological response, and remodel with the patient’s own cells.”

Humacyte's HAV has been evaluated in eight clinical studies in the United States, Europe, and Israel, including an ongoing phase 2/3 clinical trial in vascular trauma and an ongoing phase 3 trial as a hemodialysis access in end-stage kidney disease.

The HAV is an investigational product and has not been approved for sale by the FDA or any international regulatory agency, advised the company.