[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646433":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":11,"centralContacts":32,"locations":42,"responsibleParty":59,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":11,"studyType":79,"phases":80,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":45,"whyStopped":11,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"control group","PLACEBO_COMPARATOR",null,[13],"Other: control group",{"label":15,"type":16,"description":17,"interventionNames":18},"exosomes treatment group","EXPERIMENTAL","GoldenExo（NATX） treatment",[19],"Biological: exosomes treatment group",[21,27],{"type":22,"name":15,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","GoldenExo（NATX） treatment group (n=32) The specific therapeutic dose for the second stage will be evaluated and determined jointly by the investigators and the Safety Monitoring Committee (SMC) after all three dose escalation trials (1×10¹¹, 3×10¹¹, 9×10¹¹ particles) in the first stage.Subjects in both groups will receive intravenous infusions once weekly for 8 weeks (a total of 8 doses).",[15],[26],"GoldenExo（NATX） treatment group",{"type":6,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"active-comparator control：（n=16）The control group will receive an equal volume of the same buffer solution without exosomes (.Subjects in this groups will receive intravenous infusions once weekly for 8 weeks (a total of 8 doses)",[9],[31],"active-comparator",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":11,"email":37},"Yang Zhang","CONTACT","+8613910670551","emilyzy14@sina.com",{"name":39,"role":35,"phone":40,"phoneExt":11,"email":41},"Pei Heng Zhang","+8617710937961","zhangpeiheng2021@163.com",[43],{"facility":44,"status":45,"city":46,"state":11,"zip":11,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Peking University first Hospital","RECRUITING","Beijing","China","CN",{"type":50,"coordinates":51},"Point",[52,53],116.39723,39.9075,{"lat":53,"lon":52},[56],{"name":57,"role":35,"phone":58,"phoneExt":11,"email":37},"Yang Zhang, MD","008613910670551",{"type":60,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[62],{"name":63,"class":64},"ECHO Biotech","UNKNOWN","100646433","phase-1-huc-msc-exosomes-for-t2dm---safety--efficacy-100646433",false,"NCT07693036","hUC-MSC-Exosomes for T2DM - Safety & Efficacy","An Exploratory Clinical Study Assessing the Safety and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Adult Type 2 Diabetes Mellitus","HOPE-T2DM","Inclusion Criteria:\n\n1. Age 18-65 years, diagnosed with T2DM for ≥5 years (\\\u003C20 years).\n2. Regular diet and exercise control combined with the following intensive treatment regimens, with screening HbA1c remaining between 7.5% and 9.0% (FBG \\\u003C13.9mmol\u002FL):Stable dose of insulin (basal or premixed) (\\\u003C1.5u\u002Fkg·d) combined with ≥1 oral antidiabetic drug (OAD) (e.g., Metformin, SGLT2i) for ≥3 months; or Insulin combined with a GLP-1RA (maximum tolerated dose, ≤1mg Qw); or GLP-1RA (maximum tolerated dose, ≤1mg Qw) combined with ≥1 OAD for ≥3 months; or Stable dose of ≥3 OADs (must include Metformin) for ≥3 months.\n3. Fasting C-peptide ≥1.0 ng\u002FmL.\n4. Glutamic acid decarboxylase (GAD) antibody and Islet cell antibody (IAA) negative.\n5. Body Mass Index (BMI) 18.5-35 kg\u002Fm ².\n6. Subjects voluntarily participate in the study and sign the informed consent form.\n7. Female subjects of childbearing potential and non-sterilized male subjects must agree to use highly effective contraceptive methods during the study period and for 1 year following the final infusion.\n\nExclusion Criteria:\n\n1. Type 1 diabetes or other specific types of diabetes.\n2. Occurrence of severe hypoglycemia or diabetic ketoacidosis within the past 6 months.\n3. Severe cardiovascular\u002Fcerebrovascular diseases, hepatic or renal insufficiency (e.g., eGFR \\\u003C30 mL\u002Fmin·1.73m²).\n4. Active malignancy, coagulation disorders, immune system diseases.\n5. Pregnant or lactating women.\n6. Individuals with allergic constitution.\n7. Exclusion of subjects currently participating in other clinical trials.\n8. Subjects deemed unsuitable for participation by the investigator.","ALL","18 Years","65 Years",{"count":77,"type":78},66,"ESTIMATED","INTERVENTIONAL",[81,82],"PHASE1","PHASE2","The goal of this clinical trial is to Evaluate the Safety and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Adult Type 2 Diabetes Mellitus.",[85],"Type 2 Diabetes Mellitus (T2DM)",[87,88,89,90,91],"MSC-Exosomes","Exosomes","Type 2 Diabetes","Safety","Efficacy","2026-07-03",{"date":94,"type":95},"2026-07-09","ACTUAL",{"date":97,"type":95},"2026-06-05",{"date":99,"type":78},"2028-06-08",{"name":5,"class":6},1]