Mid-term results from a phase II study of surgical bypass using the Human Acellular Vessel (HAV) demonstrated an overall secondary patency rate at 72 months of 60% measured by Kaplan Meier. There was no evidence of graft rejection or infection, the authors reported.
Humacyte, the biotechnology platform company behind the product, said the publication describes the long-term analysis of the clinical trial as it evaluates the bioengineered HAV as a conduit in patients with symptomatic peripheral artery disease (PAD). The research team, led by first-named author Piotr Gutowski, MD, from the Department of Vascular Surgery at Pomeranian Medical University of Szczecin in Szczecin, Poland, concluded that “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 results were recently published in the Journal of Vascular Surgery-Vascular Science (JVS-VS).
No patients underwent amputation of the affected limb out to six years, they found, and none reported pain at rest or ischemic ulcers on the affected legs. Gutowski et al reported that “these data have demonstrated the durability of the HAV and suggest the occurrence of cellular remodeling by the host.”
Gutowski commented: “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.”
The HAV has been evaluated in eight clinical studies in the U.S., Europe and Israel, including an ongoing phase II/III clinical trial in vascular trauma and an ongoing phase III 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 Food and Drug Administration or any international regulatory agency.