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Authors
Kompa, Andrew R.
Greening, David W.
Lees, Jarmon G.
Kong, Anne M.
Cross, Jonathon
Nowland, Ashley
Phang, Ren J.
Naghipour, Saba
Deng, Yali
Darby, Jack R. T.
Mariana, Lina
Kos, Cameron
Hall, Tanya
Newcomb, Andrew
Chong, James J. H.
Ritchie, Rebecca H.
Morrison, Janna L.
Papas, Klearchos K.
Kelly, Kilian
Hausenloy, Derek J.
Loudovaris, Thomas
Lim, Shiang Y.
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Funding
Funding for this research was provided by:
Singapore Translational Research Investigator Award (MOH-STaR21jun-0003)
Centre Grant scheme (NMRC CG21APR1006)
Collaborative Centre Grant scheme (NMRC/CG21APRC006)
CArdiovascular DiseasE National Collaborative Enterprise (CADENCE) National Clinical Translational Program (MOH-001277-01)
Stafford Fox Medical Research Foundation
Medical Research Future Fund Cardiovascular Health Mission (2015523)
St Vincent’s Hospital (Melbourne) Research Endowment Fund
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Article History
Received: 22 June 2025
Accepted: 27 November 2025
First Online: 5 December 2025
Declarations
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: Cymerus™ MSCs were manufactured on behalf of the sponsor, Cynata Therapeutics Limited (https://cynata.com/), by Waisman Biomanufacturing (Madison, WI, USA). The iPSCs used to generate Cymerus™ MSCs were derived by Cellular Dynamics International (Madison, WI, USA) from peripheral blood mononuclear cells obtained from a healthy, fully consented adult donor, using a non-integrating, episomal-based reprogramming method, as previously described [ ]. Donor material was collected by the BloodCenter of Wisconsin, Inc. under informed consent and in compliance with U.S. FDA donor eligibility regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products (21 CFR 1271). Cynata Therapeutics Limited has confirmed that appropriate ethical approvals and informed donor consent were obtained for the collection and use of the human cells in accordance with applicable regulatory requirements [ ]. The human iPS-Foreskin-2 cell line used in this study was originally derived and characterized by Yu et al. [ ]. As described in the original publication, the line was generated from human neonatal foreskin fibroblasts obtained from a fully consented donor under protocols approved by the Institutional Review Board of the University of Wisconsin-Madison. The cells were provided to the authors as a gift from the originating laboratory, which confirmed that all necessary ethical approvals and informed donor consent were obtained for the collection and use of the human cells in research. All experimental procedures involving animal were approved by the Animal Ethics Committee of St Vincent’s Hospital (AEC No. 011/22: Repairing the heart with clinical-grade human stem cells. Approval date 27 July 2022).
: KK is an employee and shareholder of Cynata Therapeutics Limited. KKP is the co-founder and a stakeholder in Procyon Technologies LLC. TL holds a small ownership stake in Procyon Technologies LLC and is a member of its Scientific Advisory Board.
