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Phase 2 trial of human acellular vessel for treatment of PAD launches
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Humacyte announced it will begin a phase 2 trial of an investigational human acellular vessel for lower extremity arterial bypass in patients with peripheral artery disease.
The goal of the study is to assess the safety and efficacy of the vessel (Humacyl) in the arterial bypass position, according to a company press release.
The study will be a nonrandomized trial with a target enrollment of 20 patients over 12 months across 4 sites. The vessel will be surgically implanted in the above-the-knee, femoral-to-popliteal arterial position in the legs of patients with PAD.
“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,” Michael Belkin, MD, chief of the division of vascular and endovascular surgery at Brigham and Women’s Hospital, where the first U.S. patient was treated with the therapy, said in the release.
Humacyte’s vessel is also undergoing a phase 3 clinical trial for vascular access in patients with end-stage renal disease, according to the release.
Disclosure: Belkin reports no relevant financial disclosures.