Humacyte has announced the initiation of a US phase II arterial bypass clinical trial of Humacyl, an investigational human acellular vessel, to test its safety and efficacy as a lower extremity arterial bypass vessel in patients with peripheral artery disease.
In this non-randomised trial with a target to enrol 20 patients over the next 12 months, Humacyl will be surgically implanted in the above-the-knee, femoral-to-popliteal arterial position in the legs of patients who suffer from PAD to improve blood circulation. The study goal is to assess whether the vessel performs in the arterial bypass position, and is usable and suitable for repairing human arterial blood vessels.
The initiation of the phase II trial in the USA is a continuation of previous arterial trial surgeries that were begun across multiple sites in Poland in 2013, and completed in 2015. Humacyte enrolled its first US patient in the trial for arterial bypass at Brigham and Women’s Hospital in Boston under a Food and Drug Administration (FDA)-approved protocol. Patients will be enrolled in at least three other US sites, including the UCSF Medical Center in San Francisco, Michigan Vascular Center in Flint, and Duke University Hospital in Durham.
“The continuation of Humacyl’s phase II clinical studies as a conduit for blood flow in a patient with peripheral artery disease marks a major milestone in the field of regenerative medicine,” said Jeffrey H Lawson, chief medical officer of Humacyte. “We are heartened by the fact that Humacyte is expanding its footprint by leveraging our first in class, bioengineered vessel for multiple vascular surgery applications, including patients that undergo haemodialysis and patients with peripheral vascular disease.”
In addition to the arterial bypass study, Humacyte’s human acellular vessel is also currently undergoing a phase III clinical trial for vascular access in patients with end-stage renal disease requiring renal replacement therapy and who are not candidates for fistula. The company is also planning the development of future pipeline products that may improve treatment outcomes for patients suffering from both vascular and non-vascular diseases.
“If the results of this clinical trial are positive, then this solution has the potential to serve as a new clinical option for the many patients that face the need for artery bypass surgery each year,” says Michael Belkin, chief of the Division of Vascular and Endovascular Surgery at Brigham and Women’s Hospital.