Humacyte said yesterday that it started a phase II trial of its human acellular vessel, Humacyl, as an artificial bypass graft in patients with peripheral arterial disease.
The non-randomized trial is slated to enroll 20 patients over the next year. Humacyl will be surgically implanted above the knee in the legs of PAD patients in the hopes of improving blood circulation. The goal of the study is to evaluate the vessel’s performance in the arterial bypass position and its efficacy at repairing human arterial blood vessels.
The Research Triangle Park, N.C.-based company’s phase II trial follows previous arterial trial surgeries at sites in Poland in 2013 that finished last year.
“The continuation of Humacyl’s Phase II clinical studies as a conduit for blood flow in a patient with Peripheral Arterial Disease marks a major milestone in the field of regenerative medicine,” Humacyte’s chief medical officer Dr. Jeffrey Lawson said in prepared remarks. “We are heartened by the fact that Humacyte is expanding its footprint by leveraging our 1st in class, bioengineered vessel for multiple vascular surgery applications – including patients that undergo hemodialysis and patients with peripheral vascular disease.”
Humacyte’s artificial blood vessel is also being evaluated in a Phase III clinical trial for use in patients with end stage renal disease. The trial enrolled 350 patients who are on hemodialysis and don’t qualify for a standard surgical treatment. In October last year, the company raised $150 million in a Series B financing round to fund the phase III trial.
“Over 8.5 million people in the United States suffer from peripheral arterial disease,” Dr. Michael Belkin, of Brigham and Women’s Hospital, added. “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. We are pleased to be the first medical facility in the United States that is taking part in a key study that may lead to a meaningful impact on patients’ cardiovascular health.”