[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603066":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":33,"collaborators":37,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":43,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":11,"studyType":55,"phases":56,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":68,"whyStopped":11,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":11},{"fullName":5,"class":6},"Xuanwu Hospital, Beijing","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Exosome group","EXPERIMENTAL",null,[13],"Biological: Human umbilical cord mesenchymal stem cell derived exosomes",{"label":15,"type":16,"description":11,"interventionNames":17},"Control group","PLACEBO_COMPARATOR",[18],"Other: Placebo Control",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","Human umbilical cord mesenchymal stem cell derived exosomes","Nasal spray of hUC-MSC-Exo (low dose: 2.5×10\\^10 particles, mid-dose: 5.0×10\\^10 particles, high-dose: 1.0×10\\^11 particles), once per day for 7 days, then once per week for 3 weeks",[9],[26],"hUC-MSC-Exo",{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Placebo Control","Nasal spray of placebo control, once per day for 7 days, then once per week for 3 weeks",[15],[32],"hUC-MSC-Exo mimics",{"type":34,"investigatorFullName":35,"investigatorTitle":36,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","cuilili","Principle investigator",[38],{"name":39,"class":40},"ECHO Biotech","UNKNOWN","100603066","phase-1-huc-msc-exo-therapy-for-autoimmune-encephalitis-100603066",false,"NCT07131683","hUC-MSC-Exo Therapy for Autoimmune Encephalitis","Human Umbilical Cord Mesenchymal Stem Cell-derived ExoSomes for Autoimmune Encephalitis: a Phase I\u002FIIa Clinical Trial (MESAE)","MESAE","Inclusion Criteria:\n\n1. Aged 18-65 years, both male and female are eligible;\n2. Diagnosis of autoimmune encephalitis within 3 months of onset (meeting the 2016 Graus and Dalmau diagnostic criteria), with positive serum\u002Fcerebrospinal fluid anti-NMDAR antibodies or anti-LGI1 antibodies;\n3. Modified Rankin Scale (mRS) score ≥ 2 at enrollment;\n4. The subject or legally authorized representative is able to sign the informed consent form;\n5. Subjects of childbearing potential must agree to practice strict contraception during the study period.\n\nExclusion Criteria:\n\n1. Pre-morbid modified Rankin Scale (mRS) score ≥ 2;\n2. Known allergy to any component of the investigational product or history of severe allergic reactions;\n3. Presence of neurological or psychiatric disorders (e.g., cerebrovascular disease, Parkinson's disease, severe depression) deemed by the investigator to potentially impair trial participation or study assessments;\n4. Current or history of any clinically significant systemic diseases judged by the investigator as unsuitable for inclusion, including but not limited to:\n\n   * Severe cardiovascular diseases (e.g., congestive heart failure, severe arrhythmia, myocardial infarction)\n   * Hepatic diseases (e.g., cirrhosis)\n   * Renal diseases (e.g., requiring hemodialysis or peritoneal dialysis)\n   * Hematological diseases (e.g., hemophilia with bleeding tendency)\n   * Endocrine disorders (e.g., poorly controlled diabetes with blood glucose \\>16.8 mmol\u002FL or \\\u003C2.8 mmol\u002FL, or with severe complications)\n   * Immune system disorders (active or uncontrolled systemic autoimmune diseases, primary\u002Fsecondary immunodeficiency)\n   * Malignancies;\n5. Anatomical nasal abnormalities, nasal mucosal damage, severe rhinitis, or other nasal conditions affecting drug administration;\n6. Requiring nasogastric tube placement;\n7. Organ function meeting any of the following criteria:\n\n   1. Absolute neutrophil count (ANC) \\\u003C1.5×10⁹\u002FL, platelets (PLT) \\\u003C100×10⁹\u002FL, hemoglobin (Hb) \\\u003C90 g\u002FL\n   2. Aspartate aminotransferase (AST) \\>2.5×ULN and\u002For alanine aminotransferase (ALT) \\>2.5×ULN, total bilirubin (TBIL) \\>1.5×ULN\n   3. Creatinine \\>1.5×ULN\n   4. Without anticoagulant\u002Fantiplatelet therapy: International normalized ratio (INR) \\>1.7 or activated partial thromboplastin time (APTT) \\>1.25×ULN With anticoagulant\u002Fantiplatelet therapy: INR \\>3.0 or APTT \\>1.5×ULN;\n8. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable HBV-DNA; or positive for hepatitis C antibody (HCVAb), Treponema pallidum antibody (TPAb\u002FRPR), or human immunodeficiency virus antibody (HIV);\n9. Pregnant or lactating patients;\n10. Contraindications for MRI (e.g., metal implants such as pacemakers, claustrophobia);\n11. Participation in any clinical trial involving investigational drugs within 3 months prior to dosing (or within 5 half-lives of last dose, whichever is longer);\n12. Major trauma or surgery within 3 months prior to dosing, or planned surgery during the trial (excluding laparoscopy or minor procedures \\>4 weeks before baseline; excluding thymoma\u002Fteratoma surgery);\n13. History of drug abuse or alcoholism within 1 year prior to dosing;\n14. Previous treatment with stem cells or derivatives;\n15. Any other condition that may increase patient risk or interfere with result interpretation, as determined by the investigator.","ALL","18 Years","65 Years",{"count":53,"type":54},38,"ESTIMATED","INTERVENTIONAL",[57,58],"PHASE1","PHASE2","This is a phase I\u002FIIa study to investigate the safety and preliminary efficacy of intranasal admnistration of human umbilical mesenchymal stem cell-derived exosome (hUC-MSC-Exo) for patients with autoimmune encephalitis.",[61],"Autoimmune Encephalitis",[63,64,65,66,67],"mesenchymal stem cell","exosome","autoimmune encephalitis","safety","efficacy","NOT_YET_RECRUITING","2025-08-19",{"date":71,"type":72},"2025-08-20","ACTUAL",{"date":74,"type":54},"2025-11-01",{"date":76,"type":54},"2027-08-31",{"name":5,"class":6}]