Humacyte, Inc. received FDA clearance for its Investigational New Drug (IND) application to study the coronary tissue engineered vessel (CTEV).
The company will launch a Phase 2a first-in-human clinical trial this quarter for use in coronary artery bypass grafting (CABG).
The study will enroll 10 adult patients to evaluate the safety and efficacy of the CTEV.
Researchers will measure the primary endpoint of vessel patency, or blood flow, two months after implantation.
The trial includes a long-term monitoring period of up to three years for all participants.
The CTEV serves as a potential off-the-shelf alternative to traditional saphenous vein grafts.
Surgeons perform more than 400,000 coronary bypass procedures annually in the U.S.
Current grafting methods often lead to harvesting site complications and inconsistent vessel quality.