Humacyte to begin testing bioengineered blood vessel in heart bypass surgery
Durham-based Humacyte, a regenerative medicine company, will soon begin a first-in-human clinical study of its bioengineered blood vessel in patients undergoing coronary artery bypass grafting (CABG).
The U.S. Food and Drug Administration accepted the company’s Investigational New Drug (IND) application for the Phase 2a study.
The study, to begin in the current quarter, will test Humacyte’s coronary tissue-engineered vessel (CTEV) for efficacy and safety in 10 adult patients. An assessment of patency (blood flow) through the CTEV will be performed two months after implant, and patients will be followed for up to three years. 
“No new off-the-shelf conduits have been introduced for CABG in the past 40 years, and our IND clearance and upcoming Phase 2a study are major milestones for the CTEV as a potential innovation in CABG,” said Laura Niklason, M.D., Ph.D., founder and chief executive officer of Humacyte. “Our preclinical results suggest that the CTEV may be a promising off-the-shelf alternative to saphenous vein grafts in CABG, and we look forward to evaluating this prospect in its first human clinical study.”
CABG (Coronary Artery Bypass Grafting)
More than 400,000 coronary arterial grafts are implanted each year in the United States, and the surgery has improved the survival and quality of life for many patients with coronary artery disease.
The current conduits used for CABG are autologous vessels, those harvested from the patient’s own body, most often the saphenous vein in the leg. However, saphenous vein graft patency after one year is often as low as 75%, and harvesting from the patient can result in poor vein quality, as well as surgical wound complications that can prolong hospitalization and require additional surgery. In addition, some patients don’t have adequate saphenous vein available for use in surgical bypass.
The CTEV is a first-in-class, universally implantable bioengineered human blood vessel designed to be available to surgeons off-the-shelf.
In preparation for the planned Phase 2a study, the CTEV has been studied in preclinical CABG models in pigs, sheep, and baboons. The results of a six-month preclinical study in baboons were recently published in JACC: Basic to Translational Science.
The CTEV was observed to sustain patency, recellularize with host vascular smooth muscle and endothelial cells, and remodel to effectively reduce the initial size mismatch between the CTEV and the animals’ right coronary arteries.
The CTEV is produced in the same biomanufacturing system as Humacyte’s acellular tissue-engineered vessel (ATEV). Both vessels are grown in the lab from banked human vascular cells that are seeded onto biodegradable tubular scaffolds. The vessels can be produced in varying diameters and lengths within a few weeks. They are then “de-cellularized” so they won’t trigger an immune response when surgically implanted into a patient.
The FDA approved ATEV in December 2024 for the treatment of extremity vascular trauma in adults when vein grafts from a patient’s own body are not feasible. The product is sold under the brand name Symvess.
ATEVs are also currently in late-stage clinical trials targeting other vascular applications, including arteriovenous access for hemodialysis and peripheral artery disease. Preclinical development is also underway in pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications.
Roots from Duke University
Humacyte was founded in 2004 by three Duke University scientists: Niklason, a leader in cellular therapies and regenerative medicine; biomedical engineer Shannon Dahl, Ph.D.; and molecular biologist Juliana Blum, Ph.D.
The North Carolina Biotechnology Center provided the company a $150,000 Small Business Research Loan in 2006 to support its early work.
Humacyte became a publicly traded company in 2021. Its shares are traded on the Nasdaq stock exchange under the symbol HUMA.
Read more about Humacyte:
Humacyte gets FDA approval for bioengineered blood vessel | North Carolina Biotechnology Center