Humacyte, which focuses on regenerative medicine, has started a Phase II trial of its artificial blood vessel.

The U.S. Phase II arterial bypass clinical trial of HUMACYL, its investigational human acellular vessel (HAV), will test the safety and efficacy as a lower extremity arterial bypass vessel in patients with peripheral arterial disease (PAD).

In this non-randomized trial with a target to enroll 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. This 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 United States is a continuation of previous arterial trial surgeries that were begun across multiple sites in Poland in 2013, and completed in 2015.

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,” said Jeffrey H. Lawson, M.D., Ph.D., 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 hemodialysis and patients with peripheral vascular disease.”

In addition to the arterial bypass study, Humacyte’s HAV is also currently undergoing a Phase III clinical trial for vascular access in patients with End Stage Renal Disease (kidney 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.

Over 8.5 million people in the United States suffer from Peripheral Arterial Disease.