[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100540773":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":33,"studyPopulation":26,"armGroups":34,"interventions":41,"overallOfficials":47,"centralContacts":51,"locations":57,"responsibleParty":78,"collaborators":81,"id":85,"slug":26,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":26,"eligibilityCriteria":90,"healthyVolunteers":86,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":26,"studyType":97,"phases":98,"briefSummary":99,"conditions":100,"keywords":26,"overallStatus":59,"whyStopped":26,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Anhui Provincial Hospital","OTHER_GOV",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":26},[9,13],{"measure":10,"description":11,"timeFrame":12},"Dose-Limiting Toxicity(DLT)","Number of Dose-limiting toxicity in 28 days after injection","4 weeks after initial infusion",{"measure":14,"description":15,"timeFrame":16},"Adverse Event(AE),Serious Adverse Event(SAE),Treatment Emergent Adverse Event(TEAE)and Treatment Related Adverse Event(TRAE)","Number of treatment-related adverse events,treatment emergent adverse event,treatment related adverse event or serious adverse events as assessed by CTCAE v5.0","From the date of initial infusion to 180 days after initial infusion",[18,22],{"measure":19,"description":20,"timeFrame":21},"Objective Response Rate(ORR)","Percentage of participants achieved Complete Response(CR) or Partial Response(PR)","28 days after initial infusion",{"measure":23,"description":24,"timeFrame":25},"Overall Survival(OS)","The time from initial infusion to death","100 days after initial infusion",null,{"allocation":28,"interventionModel":29,"interventionModelDescription":26,"primaryPurpose":30,"observationalModel":26,"timePerspective":26,"maskingInfo":31},"NA","SINGLE_GROUP","TREATMENT",{"masking":32,"maskingDescription":26,"whoMasked":26},"NONE","A multiple centers, open label, dose escalation study to evaluate the safety,tolerability and preliminary efficacy of iMSC in subjects with SR-aGVHD",[35],{"label":36,"type":37,"description":38,"interventionNames":39},"iMSC injection","EXPERIMENTAL","Low dose injection once a week; Low dose injection twice a week; High dose injection once a week; High dose injection twice a week;",[40],"Biological: iMSC",[42],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":26},"BIOLOGICAL","iMSC","Subjects will receive 4 or more times of iMSC injection",[36],[48],{"name":49,"affiliation":5,"role":50},"Xiaoyu Zhu, PH.D","PRINCIPAL_INVESTIGATOR",[52],{"name":53,"role":54,"phone":55,"phoneExt":26,"email":56},"Xiaoyu Zhu, phd","CONTACT","+86 15255456091","xiaoyuz@ustc.edu.cn",[58],{"facility":5,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"RECRUITING","Hefei","Anhui","230036","China","CN",{"type":66,"coordinates":67},"Point",[68,69],117.28083,31.86389,{"lat":69,"lon":68},[72,74],{"name":73,"role":54,"phone":55,"phoneExt":26,"email":56},"Zhu Xiaoyu, Ph.D",{"name":75,"role":54,"phone":76,"phoneExt":26,"email":77},"Sun Guangyu","+86 13956970687","sunguangyu_vip@foxmail.com",{"type":50,"investigatorFullName":79,"investigatorTitle":80,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Xiaoyu Zhu","Chief physician",[82],{"name":83,"class":84},"Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)","UNKNOWN","100540773",false,"NCT06321198","A Trial to Evaluate the Safety and Preliminary Efficacy of iMesenchymal Stromal Cells(iMSC) in Subjects With SR-aGVHD","A Trial to Evaluate the Safety and Preliminary Efficacy of Human Induced Pluripotent Stem Cell Derived Mesenchymal Stromal Cells in Subjects With Steroid-refractory Acute Graft-Versus-Host Disease","Inclusion Criteria:\n\n1.Subjects who understand and voluntarily sign the Informed Consent Form(ICF); 2.4-70 years; 3.Subjects with SR-aGVHD; 4.ECOG≤2; 5.Subjects with II to IV grades of steroid hormone resistance;\n\nExclusion Criteria:\n\n1. Accepted systemic or local treatment of mesenchymal stem cells;\n2. Have severe allergy to blood products or have allergy history of heterologous protein;\n3. Expected survival period within 3 months;\n4. Alanine transaminase(ALT)or Aspartate aminotransferase(AST)\\>2\\*upper limit of normal(ULN);Creatinine clearance rate≤30ml\u002Fmin or Blood Urea Nitrogen(BUN)\\>2\\*upper limit of normal(ULN), International Normalized Ratio (INR)\\>1.5\\*upper limit of normal(ULN);\n5. Have severe hepatic veno-occlusive disease(HVOD);\n6. Have severe lung disease like severe lung infection;\n7. Have history of severe acute myocardial infarction or have uncontrolled angina pectoris,arrhythmia and severe heart failure;\n8. Proved having resistant hypertension within 6 months before enrollment;\n9. Have active thrombus;\n10. Have untreated or uncertain active solid tumors within 5 years;\n11. Have alcohol or drug addiction or with a clear history of mental disorders or with a history of drug abuse or drug use of psychotropic substances;\n12. Human immunodeficiency virus(HIV)antibody positive, treponema pallidum (TP) antibody positive;\n13. Have active hepatitis B or hepatitis C;\n14. Have gastrointestinal symptoms which not caused by GVHD\n15. Pregnant or lactating female subjects, or subjects who are unable to comply with contraceptives from the study period to 6 months after the end of this study;\n16. Subjects who have participated in other clinical trials and have used other study products within 12 weeks before screening;\n17. Not suitable for this clinical trial for other reasons.","ALL","4 Years","70 Years",{"count":95,"type":96},12,"ESTIMATED","INTERVENTIONAL",[28],"A study to evaluate the safety and preliminary efficacy of iMSC in subjects with SR-aGVHD",[101],"Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD)","2026-03-24",{"date":104,"type":105},"2026-03-27","ACTUAL",{"date":107,"type":105},"2024-02-10",{"date":109,"type":96},"2027-03-02",{"name":5,"class":6},1]