[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638388":3},{"organization":4,"armGroups":7,"interventions":44,"overallOfficials":50,"centralContacts":58,"locations":64,"responsibleParty":82,"collaborators":50,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":50,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":50,"enrollmentInfo":93,"targetDuration":50,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":105,"whyStopped":50,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"BOE Technology Group Co., Ltd.","INDUSTRY",[8,14,18,22,27,30,34,38,41],{"label":9,"type":10,"description":11,"interventionNames":12},"Human Umbilical Cord Mesenchymal Stromal Cells Injection（low-dose group）","EXPERIMENTAL","5.0×10\\^7 cells,Single intravenous infusion",[13],"Drug: Human Umbilical Cord Mesenchymal Stem Cells Injection",{"label":15,"type":10,"description":16,"interventionNames":17},"Human Umbilical Cord Mesenchymal Stromal Cells Injection（medium-dose group）","1.0×10\\^8 cells,Single intravenous infusion",[13],{"label":19,"type":10,"description":20,"interventionNames":21},"Human Umbilical Cord Mesenchymal Stromal Cells Injection（high-dose group）","2.0×10\\^8 cells,Single intravenous infusion",[13],{"label":23,"type":24,"description":16,"interventionNames":25},"Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection（medium-dose group）","PLACEBO_COMPARATOR",[26],"Drug: Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection",{"label":28,"type":24,"description":20,"interventionNames":29},"Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection（high-dose group）",[26],{"label":31,"type":10,"description":32,"interventionNames":33},"Human Umbilical Cord Mesenchymal Stromal Cells Injection 1","Based on the results from the Phase Ia trial, dose group 1 will be considered for the Phase Ib trial.For multiple dosing, it is initially planned to administer the injection once on Day 0, Day 7, and Day 14, for a total of 3 doses.",[13],{"label":35,"type":10,"description":36,"interventionNames":37},"Human Umbilical Cord Mesenchymal Stromal Cells Injection 2","Based on the results from the Phase Ia trial, dose group 2 will be considered for the Phase Ib trial.For multiple dosing, it is initially planned to administer the injection once on Day 0, Day 7, and Day 14, for a total of 3 doses.",[13],{"label":39,"type":24,"description":32,"interventionNames":40},"Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection 1",[26],{"label":42,"type":24,"description":36,"interventionNames":43},"Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection 2",[26],[45,51,55],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"DRUG","Placebo of Human Umbilical Cord Mesenchymal Stromal Cells Injection","Placebo refers to a cell-free product, whose packaging, storage conditions, expiration date, and method of administration remain consistent with those of the investigational drug.",[39,42,28,23],null,{"type":46,"name":52,"description":53,"armGroupLabels":54,"otherNames":50},"Human Umbilical Cord Mesenchymal Stem Cells Injection","the first phase (Phase Ia) is a single-dose administration",[19,9,15],{"type":46,"name":52,"description":56,"armGroupLabels":57,"otherNames":50},"the second phase (Phase Ib) is a multiple-dose administration.",[31,35],[59],{"name":60,"role":61,"phone":62,"phoneExt":50,"email":63},"Yongjun Wang Chief Physician, Professor","CONTACT","010-59978538","yongjunwang111@aliyun.com",[65],{"facility":66,"status":50,"city":67,"state":68,"zip":50,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":76,"contacts":77},"Beijing Tiantan Hospital, Capital Medical University","Beijing","Beijing Municipality","China","CN",{"type":72,"coordinates":73},"Point",[74,75],116.39723,39.9075,{"lat":75,"lon":74},[78],{"name":79,"role":61,"phone":80,"phoneExt":50,"email":81},"Shu ya Li Chief Physician","+86 13601367028","shuyali85@163.com",{"type":83,"investigatorFullName":50,"investigatorTitle":50,"investigatorAffiliation":50,"oldNameTitle":50,"oldOrganization":50},"SPONSOR","100638388","phase-1-a-phase-i-trial-of-umbilical-cord-mesenchymal-stromal-cells-for-acute-ischemic-stroke-100638388",false,"NCT07628933","A Phase I Trial of Umbilical Cord Mesenchymal Stromal Cells for Acute Ischemic Stroke","A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Human Umbilical Cord-derived Mesenchymal Stromal Cell Injection in Patients With Acute Ischemic Stroke (AIS)","Inclusion Criteria:\n\n* Age ≥18 years, both genders included.\n* Clinical diagnosis of anterior circulation ischemic stroke, and able to receive the investigational product within 48 hours after the onset of stroke symptoms.\n* National Institutes of Health Stroke Scale (NIHSS) score of 6-20 (inclusive), with a score of \\\u003C2 on item Ia of the NIHSS.\n* Pre-stroke modified Rankin Scale (mRS) score ≤1.\n* The participant voluntarily agrees to participate in this study, signs the informed consent form personally or via a legal guardian, and has good compliance.\n\nExclusion Criteria:\n\n* Planned or already performed thrombectomy for the current stroke.\n* Treatment with neuroprotective agents after the current stroke.\n* History of cerebral hemorrhage, subarachnoid hemorrhage, or hemorrhagic transformation after the current ischemic stroke, and judged by the investigator to be unsuitable for participation in the clinical trial.\n* Uncontrolled systemic diseases, including but not limited to: hypertension (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure ≥100 mmHg), diabetes mellitus (acute diabetic complications such as ketoacidosis, hyperglycemic hyperosmolar state, lactic acidosis, or hypoglycemic coma within the past 3 months, or glycated hemoglobin \\>8.5%, or poorly controlled blood glucose \\[blood glucose \\>16.8 mmol\u002FL or \\\u003C2.8 mmol\u002FL\\]), renal disease (eGFR \\\u003C30 mL\u002Fmin), liver failure (Child-Pugh Class C), severe heart failure (New York Heart Association \\[NYHA\\] Class IV), severe chronic respiratory disease.\n* Organ function meeting any one or more of the following criteria:\n\n  1. Absolute neutrophil count (ANC) \\\u003C1.5×10⁹\u002FL, platelet count (PLT) \\\u003C100×10⁹\u002FL, hemoglobin (Hb) \\\u003C90 g\u002FL;\n  2. Aspartate aminotransferase (AST) \\>2.5× upper limit of normal (ULN) and\u002For alanine aminotransferase (ALT) \\>2.5×ULN, serum total bilirubin (TBIL) \\>1.5×ULN;\n  3. Creatinine (Cr) \\>1.5×ULN;\n  4. For patients not receiving anticoagulant or antithrombotic therapy: international normalized ratio (INR) \\>1.7 or activated partial thromboplastin time (APTT) \\>1.25×ULN; for patients receiving anticoagulant or antithrombotic therapy: INR \\>3.0 or APTT \\>1.5×ULN.\n* Diagnosis of immunodeficiency disease, or long-term use of immunosuppressants or systemic corticosteroids at high doses within a short period before screening.\n* Epilepsy, Alzheimer's disease, Parkinson's disease, severe depression, or other neurological or psychiatric disorders that, in the investigator's opinion, could affect the participant's ability to participate in the trial or interfere with study assessments.\n* Presence of autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, etc.).\n* Inability to undergo cranial CT\u002FMRI examination for any reason (e.g., metallic implants such as cardiac pacemakers, claustrophobia, etc.).\n* Participation in another clinical trial of an investigational drug within 3 months before screening.\n* Pregnancy, breastfeeding, planned pregnancy, or inability to use effective contraceptive measures.\n* Any other condition that, in the investigator's judgment, makes the participant unsuitable for inclusion in this study.","ALL","18 Years",{"count":94,"type":95},35,"ESTIMATED","INTERVENTIONAL",[98],"PHASE1","Study Methods: The trial consists of two phases, both including a placebo control.\n\nPhase Ia (single-dose, dose-escalation): Three dose groups (low, medium, high) are set. This is a multicenter, randomized, double-blind, placebo-controlled, single-dose, dose-escalation trial. Dose escalation to the next level is permitted only after safety assessment at 28 days post-dose in the previous group.\n\nPhase Ib (multiple-dose): Based on Phase Ia results, two dose groups will be selected. The product is administered on Day 0, Day 7, and Day 14 (3 doses total). The trial remains randomized, double-blind, and placebo-controlled.",[101,102],"Acute Ischemic Stroke","AIS",[102,104],"hUC-MSCs","NOT_YET_RECRUITING","2026-06-01",{"date":108,"type":109},"2026-06-05","ACTUAL",{"date":111,"type":95},"2026-06-30",{"date":113,"type":95},"2029-11-30",{"name":5,"class":6},1]