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This substantially increases the RV load, wall stress, maladaptive remodelling, and dysfunction, which in turn increases the risk of death or transplantation.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods and results<\/jats:title><jats:p>We conducted a phase 1 open-label multicentre trial to assess the safety and feasibility of Lomecel-B as an adjunct to second-stage HLHS surgical palliation. Lomecel-B, an investigational cell therapy consisting of allogeneic medicinal signalling cells (MSCs), was delivered via intramyocardial injections. The primary endpoint was safety, and measures of RV function for potential efficacy were obtained. Ten patients were treated. None experienced major adverse cardiac events. All were alive and transplant-free at 1-year post-treatment, and experienced growth comparable to healthy historical data. Cardiac magnetic resonance imaging (CMR) suggested improved tricuspid regurgitant fraction (TR RF) via qualitative rater assessment, and via significant quantitative improvements from baseline at 6 and 12 months post-treatment (P &amp;lt; 0.05). Global longitudinal strain (GLS) and RV ejection fraction (EF) showed no declines. To understand potential mechanisms of action, circulating exosomes from intramyocardially transplanted MSCs were examined. Computational modelling identified 54 MSC-specific exosome ribonucleic acids (RNAs) corresponding to changes in TR RF, including miR-215-3p, miR-374b-3p, and RNAs related to cell metabolism and MAPK signalling.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Intramyocardially delivered Lomecel-B appears safe in HLHS patients and may favourably affect RV performance. Circulating exosomes of transplanted MSC-specific provide novel insight into bioactivity. Conduct of a controlled phase trial is warranted and is underway.<\/jats:p><jats:p>Trial registration number NCT03525418.<\/jats:p><\/jats:sec>","DOI":"10.1093\/ehjopen\/oead002","type":"journal-article","created":{"date-parts":[[2023,1,11]],"date-time":"2023-01-11T18:40:43Z","timestamp":1673462443000},"source":"Crossref","is-referenced-by-count":12,"title":["Intramyocardial cell-based therapy with Lomecel-B during bidirectional cavopulmonary anastomosis for hypoplastic left heart syndrome: the ELPIS phase I trial"],"prefix":"10.1093","volume":"3","author":[{"given":"Sunjay","family":"Kaushal","sequence":"first","affiliation":[{"name":"The Heart Center, Division of Cardiovascular-Thoracic Surgery, Ann & Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine , 225 E. Chicago Avenue, Chicago, IL 60611 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7751-5032","authenticated-orcid":false,"given":"Joshua M","family":"Hare","sequence":"additional","affiliation":[{"name":"Longeveron Inc, 1951 NW 7th Avenue , Suite 520, Miami, FL 33136 , USA"},{"name":"Department of Medicine and Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine , 1501 NW 10th Avenue, Miami, FL 33136 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jessica R","family":"Hoffman","sequence":"additional","affiliation":[{"name":"Wallace H. Coulter Department of Biomedical Engineering, Georgia Institute of Technology & Emory University School of Medicine , 313 Ferst Drive, Atlanta, GA 30332 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Riley M","family":"Boyd","sequence":"additional","affiliation":[{"name":"The Heart Center, Division of Cardiovascular-Thoracic Surgery, Ann & Robert H. Lurie Children's Hospital of Chicago, Northwestern University Feinberg School of Medicine , 225 E. Chicago Avenue, Chicago, IL 60611 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kevin N","family":"Ramdas","sequence":"additional","affiliation":[{"name":"Longeveron Inc, 1951 NW 7th Avenue , Suite 520, Miami, FL 33136 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicholas","family":"Pietris","sequence":"additional","affiliation":[{"name":"Division of Pediatric Cardiology, Department of Pediatrics, University of Maryland School of Medicine , 110 S. Paca Street, Baltimore, MD 21201 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9428-0979","authenticated-orcid":false,"given":"Shelby","family":"Kutty","sequence":"additional","affiliation":[{"name":"Helen B. Taussig Heart Center, The Johns Hopkins Hospital and Johns Hopkins University , 1800 Orleans St., Baltimore, MD 21287 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James S","family":"Tweddell","sequence":"additional","affiliation":[{"name":"Heart Institute, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue , Cincinnati, OH 45229 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S Adil","family":"Husain","sequence":"additional","affiliation":[{"name":"Division of Pediatric Cardiothoracic Surgery, University of Utah\/Primary Children's Medical Center , 295 Chipeta Way, Salt Lake City, Utah 84108 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shaji C","family":"Menon","sequence":"additional","affiliation":[{"name":"Department of Radiology, University of Utah\/Primary Children's Medical Center , 295 Chipeta Way, Salt Lake City, UT 84108 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linda M","family":"Lambert","sequence":"additional","affiliation":[{"name":"Division of Pediatric Cardiology, University of Utah\/Primary Children's Medical Center , 295 Chipeta Way, Salt Lake City, UT 84108 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David A","family":"Danford","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Children's Hospital & Medical Center, Nebraska Medicine, Department of Pediatrics, University of Nebraska , 983332 Nebraska Medical Center, Omaha, NE 68198 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Seth J","family":"Kligerman","sequence":"additional","affiliation":[{"name":"Department of Radiology, University of California San Diego , 200 W. Arbor Drive, San Diego, CA 92103 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Narutoshi","family":"Hibino","sequence":"additional","affiliation":[{"name":"Department of Surgery, The University of Chicago Medical Center , 5841 S. Maryland Avenue, Chicago, IL 60637 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laxminarayana","family":"Korutla","sequence":"additional","affiliation":[{"name":"Department of Surgery (Cardiac), Yale School of Medicine, Yale University , 789 Howard Avenue, New Haven, CT 06510 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Prashanth","family":"Vallabhajosyula","sequence":"additional","affiliation":[{"name":"Department of Surgery (Cardiac), Yale School of Medicine, Yale University , 789 Howard Avenue, New Haven, CT 06510 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael J","family":"Campbell","sequence":"additional","affiliation":[{"name":"Department of Pediatrics, Duke University School of Medicine , 2301 Erwin Road, Durham, NC 27705 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aisha","family":"Khan","sequence":"additional","affiliation":[{"name":"Department of Medicine and Interdisciplinary Stem Cell Institute, University of Miami Miller School of Medicine , 1501 NW 10th Avenue, Miami, FL 33136 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Naioti","sequence":"additional","affiliation":[{"name":"Longeveron Inc, 1951 NW 7th Avenue , Suite 520, Miami, FL 33136 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keyvan","family":"Yousefi","sequence":"additional","affiliation":[{"name":"Longeveron Inc, 1951 NW 7th Avenue , Suite 520, Miami, FL 33136 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0867-2322","authenticated-orcid":false,"given":"Danial","family":"Mehranfard","sequence":"additional","affiliation":[{"name":"Longeveron Inc, 1951 NW 7th Avenue , Suite 520, Miami, FL 33136 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"McClain-Moss","sequence":"additional","affiliation":[{"name":"Longeveron Inc, 1951 NW 7th Avenue , Suite 520, Miami, FL 33136 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3099-2421","authenticated-orcid":false,"given":"Anthony A","family":"Oliva","sequence":"additional","affiliation":[{"name":"Longeveron Inc, 1951 NW 7th Avenue , Suite 520, Miami, FL 33136 , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael E","family":"Davis","sequence":"additional","affiliation":[{"name":"Wallace H. 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