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Article History

Received: 14 November 2025

Accepted: 17 July 2026

First Online: 27 July 2026

Declarations

Ethics approval and consent to participate: Human cell and human embryonic stem cell ethics: All experiments involving human cells and tissues were approved by the Institutional Review Board of the National Center for Child Health and Development (Approval No. 2021–178). In accordance with the Declaration of Helsinki, written informed consent was obtained from all tissue and cell donors. For donors under 18 years of age, written informed consent was obtained from their parents or legal guardians. Human cells used in this study were handled in accordance with the Ethical Guidelines for Medical and Health Research Involving Human Subjects issued by the Ministry of Health, Labour and Welfare (MHLW) and the Ministry of Education, Culture, Sports, Science and Technology (MEXT), Japan, as well as the Ethical Guidelines for Clinical Studies of the MHLW. The human embryonic stem cell (hESC) line used in this study was banked following approval by the Institutional Review Board of the National Institute of Biomedical Innovation (approved on May 9, 2006). The derivation and culture of hESCs were performed in accordance with the Guidelines for Derivation and Distribution of Human Embryonic Stem Cells (MEXT Notification No. 156, August 21, 2009; MEXT Notification No. 86, May 20, 2010) and the Guidelines for Utilization of Human Embryonic Stem Cells (MEXT Notification No. 157, August 21, 2009; MEXT Notification No. 87, May 20, 2010). The present study did not involve the recruitment of human participants or the collection of new human biological samples. Therefore, no additional informed consent was required. Animal ethics: All animal experiments were approved by the Institutional Animal Care and Use Committee (IACUC) of the National Center for Child Health and Development and were conducted in accordance with the Basic Guidelines for the Conduct of Animal Experiments in Implementing Agencies under the Jurisdiction of the Ministry of Health, Labour and Welfare (MHLW Notification No. 0220–1, February 20, 2015). The animal experimental protocols were approved by the Institutional Animal Care and Use Committee of the National Center for Child Health and Development (Approval No. A2000-001-C25; Project Title: “Regenerative Therapy Research and Drug Discovery Platform Development”) and by the University of Tokyo (Approval No. A2024M024; Project Title: “Tracheal Reconstruction Experiments in a Porcine Model”). All animal procedures were performed in accordance with the approved protocols and in compliance with the ARRIVE 2.0 guidelines.

Competing interests: AU and CJ are co-researchers with Dai Nippon Printing Ltd. AU is a stockholder of iHaes. AU is the associate editor of the journal and was not involved in the peer review process of the article. The other authors declare that there is no conflict of interest regarding the work described herein.