{"paper_id":"390da2be-67e9-4b35-b81b-b8b32e4cca94","body_text":"Intravenous human umbilical cord-derived mesenchymal stem cell transplantation for ischemic stroke (MERIT): a prospective, single arm, phase I trial | 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 Intravenous human umbilical cord-derived mesenchymal stem cell transplantation for ischemic stroke (MERIT): a prospective, single arm, phase I trial Junwei Hao, Lili Cui, Ming Xiao, Qian Zhang, Haijie Liu, Yi Reb, and 15 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5396697/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 Umbilical cord-derived mesenchymal stem cells (UC-MSCs) hold a significant promise as an innovative therapy for ischemic stroke, but the optimal transplantation strategy remains to be explored. This open label, single arm, phase I study (ClinicalTrials.gov:NCT05697718) included 18 patients with subacute ischemic stroke, who exhibited a National Institutes of Health Stroke Scale (NIHSS) score of 6-20 (median 9, interquartile range 8-12). The patients received a single intravenous transplantation of 50, 100, or 200 million UC-MSCs (n=6 for each dose), and were followed up for 24 weeks. The primary outcome was the safety profile, and secondary outcome was the preliminary efficacy, with exploration on immunological changes. Possible treatment-related adverse events were dizziness, nausea, sweating, fatigue, and epilepsy. No serious adverse events occurred. A reduction in NIHSS score by 1~5 points was observed in 14 patients at the final follow-up. In conclusion, intravenous transplantation of UC-MSCs were well-tolerated in the stroke patients. Health sciences/Neurology/Neurological disorders/Stroke Health sciences/Diseases/Neurological disorders/Stroke Full Text Additional Declarations Yes there is potential Competing Interest. G. G. is a co-founder and the chief executive officer of Shanghai IxCell Biotech Co. Ltd. X. M. is an employee of Shanghai IxCell Biotech Co. Ltd. Supplementary Files StatisticalAnalysisPlan.pdf Studyprotocol.pdf SupplementaryMaterials.pdf 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. 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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-5396697\",\"acceptedTermsAndConditions\":true,\"allowDirectSubmit\":true,\"archivedVersions\":[],\"articleType\":\"Article\",\"associatedPublications\":[],\"authors\":[{\"id\":378395653,\"identity\":\"f47868e9-88d0-438f-8d8e-76bb96008a24\",\"order_by\":0,\"name\":\"Junwei Hao\",\"email\":\"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA5klEQVRIiWNgGAWjYBACAyhmYGNvYDjAwCAhJ0+8Fp4DIC0WxoYNRGiBAIkEEFmRCNKIF5izHz5QzLvjsByf5BvDwwVAjYwNzA8f3cCjxbInLcGY98xhYzbpHIPDMxgk8tgZ2IyNc/A57ECOgTFv2+3ENum0hMM8DBLFjA08QO34tJx/A9ZS3yZ5DKwlseEAIS03ILYksEkwHyBWy7MEw7lt/w3beJIPHJ5hIGFs2EzIL+eTjxm8bUuTl28/2Py5oKJOTp69+eFjfFqAgA0eN8zgaGLGrxys8AFCyygYBaNgFIwCLAAASJZHOhbTDksAAAAASUVORK5CYII=\",\"orcid\":\"https://orcid.org/0000-0002-3075-5434\",\"institution\":\"Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, 100053, China.\",\"correspondingAuthor\":true,\"prefix\":\"\",\"firstName\":\"Junwei\",\"middleName\":\"\",\"lastName\":\"Hao\",\"suffix\":\"\"},{\"id\":378395654,\"identity\":\"bf9c28d6-5cfe-4b25-b2f1-09d7014fe267\",\"order_by\":1,\"name\":\"Lili Cui\",\"email\":\"\",\"orcid\":\"\",\"institution\":\"Department of Neurology, Xuanwu Hospital, Capital Medical University, Beijing, 100053, China.\",\"correspondingAuthor\":false,\"prefix\":\"\",\"firstName\":\"Lili\",\"middleName\":\"\",\"lastName\":\"Cui\",\"suffix\":\"\"},{\"id\":378395655,\"identity\":\"168cf73a-ce4d-485b-b5c5-7efa8c8a7bb0\",\"order_by\":2,\"name\":\"Ming Xiao\",\"email\":\"\",\"orcid\":\"\",\"institution\":\"Shanghai Ixcell Biotech Co. 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