Humacyte has announced that the US Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for a first-in-human clinical study of the coronary tissue engineered vessel (CTEV) in coronary artery bypass grafting (CABG). Humacyte plans to initiate a phase 2a study of the CTEV in CABG patients during the current quarter.
“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, founder and CEO 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.”
The FDA has approved Humacyte’s study design for a first-in-human clinical trial titled “A Phase 2a Study for the Evaluation of Safety and Efficacy of Humacyte’s Coronary Tissue Engineered Vessel (CTEV) as a Vascular Conduit for Coronary Artery Bypass Grafting in Patients with Coronary Artery Disease,” to be conducted in ten adult patients. An assessment of patency through the CTEV will be performed two months after implant, and patients will be followed for up to three years.
The current conduits used for CABG are autologous vessels, including the internal mammary artery, the radial artery and saphenous vein, which is used in the majority of CABG operations. However, saphenous vein graft (SVG) patency at one year is often as low as 75%, and SVG harvesting from the patient can result in variable vein quality as well as surgical wound complications, such as infection, that can prolong hospitalisation and require additional surgical interventions, Humacyte states in a press release. In addition, a number of patients do not have adequate saphenous vein available for use in surgical bypass.
Humacyte describes the CTEV as a “first-in-class, universally implantable bioengineered human blood vessel”, which is produced in the same manufacturing system as the company’s FDA-approved acellular tissue engineered vessel (ATEV).
CTEV is designed to be available off-the-shelf, and does not require further injuring the patient to obtain arterial replacement material. 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 and the CTEV was observed to sustain patency, recellularise 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 an investigational product and has not been approved for sale by the FDA or any other regulatory agency. For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
