FDA accepts Humacyte application for first trial of CTEV, an acellular vessel for coronary artery bypass grafting

FDA accepts Humacyte application for first trial of CTEV, an acellular vessel for coronary artery bypass grafting

On July 27, Humacyte reported that the FDA had accepted its IND application for the first study of CTEV in humans undergoing coronary artery bypass grafting. The company plans to enroll ten adult patients in the phase 2a study during the next quarter. Two months after surgery, physicians will assess whether blood is flowing through the graft, and follow-up will continue for up to three years.

In coronary artery bypass grafting, a surgeon creates a route for blood around a narrowed section of an artery that supplies the heart muscle. The graft usually comes from the patient’s own body, typically a leg vein, radial artery, or internal thoracic artery. CTEV is intended to provide a prefabricated graft when the patient has limited suitable vessels of their own.

Humacyte cultures human vascular cells until they form a protein-based extracellular matrix, then removes the cells. The operating room receives an acellular tube. In a preclinical model, cells from the recipient animal populated the vessel wall after implantation.

In a preclinical study, surgeons connected a 3.5-millimeter CTEV from the aorta to the right coronary artery in five adult baboons. After six months, blood continued to flow through all five grafts. Their lumens had narrowed to match the diameter of the coronary artery, and endothelial and smooth muscle cells from the animals were found in the graft walls.

The first human study will test the same immediate sequence: surgeons will implant a ready-made tube into the circulation, then assess after two months whether it remains patent. The FDA decision therefore moves coronary CTEV from a baboon model into the operating room.