Humacyte has announced that it plans to file an investigational new drug (IND) application with the US Food and Drug Administration (FDA) to allow first-in-human clinical testing of the small-diameter (3.5mm) acellular tissue engineered vessel (sdATEV) in coronary artery bypass grafting (CABG).
The company’s current plans for filing an IND are based on the outcome of a recent meeting held with the FDA, including agreements reached with the agency. To date only the 6mm configuration of the ATEV has been studied in human trials, specifically in studies conducted in vascular trauma repair, arteriovenous (AV) access for haemodialysis, and peripheral artery disease (PAD).
To enable the IND filing, the sdATEV has been studied in multiple preclinical CABG models. The results of a six-month preclinical study in primates were presented in November 2024 at the American Heart Association’s scientific sessions 2024 meeting (16–18 November, Chicago, USA). In the preclinical CABG model, the sdATEV was observed to sustain patency (blood flow), recellularised with the animals’ host cells, and remodelled to effectively reduce the initial size mismatch between the sdATEV and the animals’ native artery.
“We are very pleased to be moving closer to human clinical studies of the sdATEV in CABG, and our planned IND filing and initiation of first-in-human study after the FDA clearance will be a major milestone for Humacyte,” said Laura Niklason, founder and chief executive officer of Humacyte. “Our preclinical results suggest that the sdATEV may be a promising off-the-shelf alternative to native vessel grafts in CABG, and we look forward to evaluating this possibility in human clinical studies.”
The current conduits used for CABG are autologous vessels including the left internal mammary artery and saphenous vein, which is used in 80–90% of CABG surgeries. However, saphenous vein graft (SVG) patency at one year is often as low as 75% and SVG harvest can result in surgical wound infection potentially leading to prolonged hospital stay, need for revascularisation, and limb-loss, Humacyte says in a press release. In addition, some patients do not have usable saphenous vein available for surgical bypass.
“Coronary artery bypass graft surgery can be lifesaving in appropriately selected patients with coronary artery disease,” said John H Alexander (Duke Clinical Research Institute at Duke University, Durham, USA). “A long-standing, major limitation of CABG surgery has been the availability of ideal conduits to use as bypass grafts. If clinical trials are successful, this tissue-engineered graft could have the potential to transform CABG surgery by providing an unlimited supply of an off-the-shelf conduit to use in patients undergoing CABG surgery. We look forward to helping to advance this technology into human studies.”
The ATEV is a first-in-class bioengineered human tissue that is designed to be a universally implantable vascular conduit for use in arterial replacement and repair. Harvesting vein from a CABG patient may lead to complications and may not be feasible due to missing or diseased veins, ATEV is designed to be available off-the-shelf, and does not require further injuring the patient to obtain arterial replacement material.
The FDA granted a full approval for the ATEV (Symvess) on 19 December 2024 for use in adults as a vascular conduit for extremity arterial injury when urgent revascularisation is needed to avoid imminent limb loss, and when autologous vein graft is not feasible. For uses other than the FDA approval, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
