Efficacy and Safety Evaluation of Intravenous MiSaver Stem Cell Therapy in Recent Acute Myocardial Infarction: A Retrospective Phase IIa Study

Efficacy and Safety Evaluation of Intravenous MiSaver Stem Cell Therapy in Recent Acute Myocardial Infarction: A Retrospective Phase IIa Study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article Efficacy and Safety Evaluation of Intravenous MiSaver Stem Cell Therapy in Recent Acute Myocardial Infarction: A Retrospective Phase IIa Study Jackson Liu, KwoChang Ueng, ChinFeng Tsai, Chun-Hung Su, YaoTsung Chuang This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4270980/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background: Despite advancements in cardiovascular treatments, acute myocardial infarction (AMI) remains a significant health challenge. We aimed to explore the potential of stem cell therapy to improve left ventricular function post-AMI through an open-label, dose-escalating trial. The study aimed to assess the safety and feasibility of intravenous infusion of MiSaver, a prefabricated product of ABO matched allogeneic umbilical cord blood stem cells (USC), in patients following recent AMI. Methods: Participants were enrolled in cohorts of five, receiving escalating dosages of USC (0.5x10^7, 1.6x10^7, and 5.0x10^7 cells/kg). Infusions were administered 2-5 days post-AMI onset. Due to recruitment challenges during the COVID-19 pandemic, this retrospective analysis was conducted using completed low and middle dosage groups and a control group comprising 20 eligible participants meeting similar inclusion criteria. Results: The primary analysis focused on safety and adverse events (AEs) over a 12-month observational period in the treatment group. The treatment was well-tolerated, with no AEs directly attributed to MiSaver. Initial analysis of nine participants showed statistically significant improvements in left ventricular ejection fraction (LVEF) from baseline to 12 months post-treatment compared to the control group (p<0.05); however, significance was lost upon inclusion of participant 10. This participant drew attention to the analysis and exhibited unique characteristics, namely the highest body mass index (BMI) and the youngest age among all participants. Conclusion: This study suggests the potential of MiSaver in enhancing left ventricular function post-AMI. Notably, participants without morbid obesity showed significant recovery in LVEF, suggesting the exclusion of individuals with high BMI in future trials. Larger cohorts and controlled placebo studies are warranted to validate these findings and address trial limitations. Health sciences/Cardiology/Interventional cardiology Biological sciences/Stem cells/Regeneration Health sciences/Cardiology/Cardiovascular biology/Cardiac regeneration Full Text Additional Declarations Yes there is potential Competing Interest. J.L. is Director of HONYA Medical and sponsor of MiSaver. The remaining authors have no conflicts of interest to declare regarding the publication of the data and the manuscript. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-4270980","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":291511194,"identity":"8e1cb484-8bf3-47ee-99de-02675186485c","order_by":0,"name":"Jackson Liu","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAtElEQVRIiWNgGAWjYBACxgY2xgMJDDYgZuMB4rS0sTEAtaSBdROnhYENqIWB4TCYTZwW5vltCQcetp23W9t+GGhLjU00MQ47cCCx7XbytjOJQC3H0nIbCGthbwBrMTsA1MLYcJhoLeeSzc4/JFoL2GEH7MxuEG9LWsKBhHPJCWY3gLYkEOMXw+Zjhg9/lNnZm51Pf/jgQ40NEVqgKhLBdAIh5SAgD6XtiVE8CkbBKBgFIxQAALR+TDfSOgR7AAAAAElFTkSuQmCC","orcid":"","institution":"HONYA Medical PTY LTD","correspondingAuthor":true,"prefix":"","firstName":"Jackson","middleName":"","lastName":"Liu","suffix":""},{"id":291511195,"identity":"6f139e8e-0283-4551-8761-9915ccded307","order_by":1,"name":"KwoChang Ueng","email":"","orcid":"","institution":"Chung Shan Medical University Hospital","correspondingAuthor":false,"prefix":"","firstName":"KwoChang","middleName":"","lastName":"Ueng","suffix":""},{"id":291511196,"identity":"3bf31e52-a35b-445d-b800-77bc282f0c7b","order_by":2,"name":"ChinFeng Tsai","email":"","orcid":"","institution":"Chung Shan Medical University Hospital","correspondingAuthor":false,"prefix":"","firstName":"ChinFeng","middleName":"","lastName":"Tsai","suffix":""},{"id":291511197,"identity":"3061b0ac-f7a5-465b-b07f-0300f8a6ac33","order_by":3,"name":"Chun-Hung Su","email":"","orcid":"","institution":"Chung Shan Medical University Hospital","correspondingAuthor":false,"prefix":"","firstName":"Chun-Hung","middleName":"","lastName":"Su","suffix":""},{"id":291511198,"identity":"86a940bb-0180-4a2b-8e69-3376bdb7ea6c","order_by":4,"name":"YaoTsung Chuang","email":"","orcid":"","institution":"Chung Shan Medical University Hospital","correspondingAuthor":false,"prefix":"","firstName":"YaoTsung","middleName":"","lastName":"Chuang","suffix":""}],"badges":[],"createdAt":"2024-04-15 16:40:38","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4270980/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4270980/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":56008074,"identity":"949dae7c-1284-416a-9f33-786276227488","added_by":"auto","created_at":"2024-05-07 13:22:37","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":438792,"visible":true,"origin":"","legend":"","description":"","filename":"EfficacyandSafetyEvaluationofMiSaveraRetrospectivePhaseIIaStudya.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4270980/v1_covered_504eaff8-3383-4097-95a8-37547a8a6ddd.pdf"}],"financialInterests":"\u003cb\u003eYes\u003c/b\u003e there is potential Competing Interest.\nJ.L. is Director of HONYA Medical and sponsor of MiSaver. The remaining authors have no conflicts of interest to declare regarding the publication of the data and the manuscript.","formattedTitle":"Efficacy and Safety Evaluation of Intravenous MiSaver Stem Cell Therapy in Recent Acute Myocardial Infarction: A Retrospective Phase IIa Study","fulltext":[],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":false,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":true,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":true,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-4270980/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4270980/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eBackground: Despite advancements in cardiovascular treatments, acute myocardial infarction (AMI) remains a significant health challenge. We aimed to explore the potential of stem cell therapy to improve left ventricular function post-AMI through an open-label, dose-escalating trial. The study aimed to assess the safety and feasibility of intravenous infusion of MiSaver, a prefabricated product of ABO matched allogeneic umbilical cord blood stem cells (USC), in patients following recent AMI.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMethods: Participants were enrolled in cohorts of five, receiving escalating dosages of USC (0.5x10^7, 1.6x10^7, and 5.0x10^7 cells/kg). Infusions were administered 2-5 days post-AMI onset. Due to recruitment challenges during the COVID-19 pandemic, this retrospective analysis was conducted using completed low and middle dosage groups and a control group comprising 20 eligible participants meeting similar inclusion criteria.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eResults: The primary analysis focused on safety and adverse events (AEs) over a 12-month observational period in the treatment group. The treatment was well-tolerated, with no AEs directly attributed to MiSaver. Initial analysis of nine participants showed statistically significant improvements in left ventricular ejection fraction (LVEF) from baseline to 12 months post-treatment compared to the control group (p\u0026lt;0.05); however, significance was lost upon inclusion of participant 10. This participant drew attention to the analysis and exhibited unique characteristics, namely the highest body mass index (BMI) and the youngest age among all participants.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eConclusion: This study suggests the potential of MiSaver in enhancing left ventricular function post-AMI. Notably, participants without morbid obesity showed significant recovery in LVEF, suggesting the exclusion of individuals with high BMI in future trials. Larger cohorts and controlled placebo studies are warranted to validate these findings and address trial limitations.\u003c/p\u003e","manuscriptTitle":"Efficacy and Safety Evaluation of Intravenous MiSaver Stem Cell Therapy in Recent Acute Myocardial Infarction: A Retrospective Phase IIa Study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-05-02 05:37:36","doi":"10.21203/rs.3.rs-4270980/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"3d5fb337-ce9d-44e8-98e4-b197a1ecc838","owner":[],"postedDate":"May 2nd, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":30709195,"name":"Health sciences/Cardiology/Interventional cardiology"},{"id":30709196,"name":"Biological sciences/Stem cells/Regeneration"},{"id":30709197,"name":"Health sciences/Cardiology/Cardiovascular biology/Cardiac regeneration"}],"tags":[],"updatedAt":"2024-05-07T12:12:42+00:00","versionOfRecord":[],"versionCreatedAt":"2024-05-02 05:37:36","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4270980","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4270980","identity":"rs-4270980","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}