Trial Profile

First-in-human clinical trial of the small-diameter (3.5mm) acellular tissue engineered vessel (sdATEV) in coronary artery bypass grafting (CABG)

Status: Planning

Phase of Trial: Phase I

Latest Information Update: 29 May 2026

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At a glance

13 May 2026 According to Humacyte media release, the company announced submission of an Investigational New Drug (IND) application to the FDA. Plans to commence the study in the 2nd half of 2026 upon clearance by the FDA.
28 Jan 2025 New trial record
21 Jan 2025 According to Humacyte media release, the company plans to file an Investigational New Drug (IND) application with the USFDA to allow first-in-human clinical testing of the small-diameter (3.5mm) acellular tissue engineered vessel (sdATEV) in coronary artery bypass grafting (CABG), based on the outcome of a recent meeting held with the FDA, including agreements reached with the agency.

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