{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Miyagawa S"],"funding":["Japan Agency of Medical Research and Development","Japan Agency for Medical Research and Development"],"pagination":["73"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC10935836"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["15(1)"],"pubmed_abstract":["<h4>Background</h4>Cell- or tissue-based regenerative therapy is an attractive approach to treat heart failure. A tissue patch that can safely and effectively repair damaged heart muscle would greatly improve outcomes for patients with heart failure. In this study, we conducted a preclinical proof-of-concept analysis of the efficacy and safety of clinical-grade human induced pluripotent stem cell-derived cardiomyocyte (hiPSC-CM) patches.<h4>Methods</h4>A clinical-grade hiPSC line was established using peripheral blood mononuclear cells from a healthy volunteer that was homozygous for human leukocyte antigens. The hiPSCs were differentiated into cardiomyocytes. The obtained hiPSC-CMs were cultured on temperature-responsive culture dishes for patch fabrication. The cellular characteristics, safety, and efficacy of hiPSCs, hiPSC-CMs, and hiPSC-CM patches were analyzed.<h4>Results</h4>The hiPSC-CMs expressed cardiomyocyte-specific genes and proteins, and electrophysiological analyses revealed that hiPSC-CMs exhibit similar properties to human primary myocardial cells. In vitro and in vivo safety studies indicated that tumorigenic cells were absent. Moreover, whole-genome and exome sequencing revealed no genomic mutations. General toxicity tests also showed no adverse events posttransplantation. A porcine model of myocardial infarction demonstrated significantly improved cardiac function and angiogenesis in response to cytokine secretion from hiPSC-CM patches. No lethal arrhythmias were observed.<h4>Conclusions</h4>hiPSC-CM patches are promising for future translational research and may have clinical application potential for the treatment of heart failure."],"journal":["Stem cell research & therapy"],"pubmed_title":["Pre-clinical evaluation of the efficacy and safety of human induced pluripotent stem cell-derived cardiomyocyte patch."],"pmcid":["PMC10935836"],"funding_grant_id":["JP17bk0104044","JP20bm0204003"],"pubmed_authors":["Sawa Y","Takeda M","Dohi H","Li J","Imanishi-Ochi Y","Yokoyama J","Kawamura T","Kitaoka F","Nomura M","Ito E","Takahashi T","Morii E","Sasai M","Iseoka H","Harada A","Mochizuki-Oda N","Amano N","Miyagawa S"],"additional_accession":[]},"is_claimable":false,"name":"Pre-clinical evaluation of the efficacy and safety of human induced pluripotent stem cell-derived cardiomyocyte patch.","description":"<h4>Background</h4>Cell- or tissue-based regenerative therapy is an attractive approach to treat heart failure. A tissue patch that can safely and effectively repair damaged heart muscle would greatly improve outcomes for patients with heart failure. In this study, we conducted a preclinical proof-of-concept analysis of the efficacy and safety of clinical-grade human induced pluripotent stem cell-derived cardiomyocyte (hiPSC-CM) patches.<h4>Methods</h4>A clinical-grade hiPSC line was established using peripheral blood mononuclear cells from a healthy volunteer that was homozygous for human leukocyte antigens. The hiPSCs were differentiated into cardiomyocytes. The obtained hiPSC-CMs were cultured on temperature-responsive culture dishes for patch fabrication. The cellular characteristics, safety, and efficacy of hiPSCs, hiPSC-CMs, and hiPSC-CM patches were analyzed.<h4>Results</h4>The hiPSC-CMs expressed cardiomyocyte-specific genes and proteins, and electrophysiological analyses revealed that hiPSC-CMs exhibit similar properties to human primary myocardial cells. In vitro and in vivo safety studies indicated that tumorigenic cells were absent. Moreover, whole-genome and exome sequencing revealed no genomic mutations. General toxicity tests also showed no adverse events posttransplantation. A porcine model of myocardial infarction demonstrated significantly improved cardiac function and angiogenesis in response to cytokine secretion from hiPSC-CM patches. No lethal arrhythmias were observed.<h4>Conclusions</h4>hiPSC-CM patches are promising for future translational research and may have clinical application potential for the treatment of heart failure.","dates":{"release":"2024-01-01T00:00:00Z","publication":"2024 Mar","modification":"2026-06-28T03:12:13.238Z","creation":"2025-05-18T12:54:10.626Z"},"accession":"S-EPMC10935836","cross_references":{"pubmed":["38475911"],"doi":["10.1186/s13287-024-03690-8"]}}