Humacyte, a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues and advanced tissue constructs and organ systems at commercial scale, today announced the publication of “Six-year outcomes of a phase two study of human-tissue engineered blood vessels for peripheral arterial bypass,” in the Journal of Vascular Surgery-Vascular Science.
The publication describes the long-term analysis of the company’s phase two clinical trial evaluating the bioengineered human acellular vessel (HAV) as a conduit in patients with symptomatic peripheral artery disease (PAD). The researchers 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”.
This paper reports a 60% overall secondary patency rate for the phase two study at 72 months, including all patients originally enrolled, and was estimated by Kaplan Meier analysis. There was no evidence of graft rejection or infection. Additionally, no patients underwent amputation of the affected limb out to six years—a meaningful clinical and quality-of-life result, as amputation is a common outcome in many severe PAD patients. Furthermore, no patients reported pain at rest or ischemic ulcers on the affected legs. Researchers reported that “these data have demonstrated the durability of the HAV and suggest the occurrence of cellular remodelling by the host.”
Piotr Gutowski (Pomeranian Medical University, Szczecin, Poland), lead manuscript author, 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.”
“With an increasing global prevalence of PAD and more than 200 million people living with the disease, there still remains a major unmet need for long-term solutions,” said Laura Niklason, chief executive officer of Humacyte. “Key findings of this publication show that the HAV was durable and performed well in a medically complex patient cohort for long-term treatment of PAD. The HAV is designed to be available off-the-shelf, has the potential for a regenerative capacity and low infection risk, all of which are particularly important in this patient group.”
The HAV has been evaluated in eight clinical studies in the USA, Europe, and Israel, including an ongoing phase two/three clinical trial in vascular trauma and an ongoing phase three trial as a haemodialysis access in end-stage kidney disease. The HAV is an investigational product and has not been approved for sale by the US Food and Drug Administration (FDA) or any international regulatory agency.