[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100589042":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":26,"responsibleParty":40,"collaborators":26,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":26,"eligibilityCriteria":48,"healthyVolunteers":44,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":26,"studyType":55,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":65,"whyStopped":26,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":26},{"fullName":5,"class":6},"Ruijin Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","ACTIVE_COMPARATOR","conventional aGVHD prophylaxis",[13],"Combination Product: conventional aGVHD prophylaxis",{"label":15,"type":16,"description":17,"interventionNames":18},"Trial group","EXPERIMENTAL","conventional aGVHD prophylaxis + iMSC",[19,13],"Biological: iMSC",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","iMSC","1× 10\\^6\u002Fkg each time, twice a week",[15],null,{"type":28,"name":11,"description":29,"armGroupLabels":30,"otherNames":26},"COMBINATION_PRODUCT","Cyclosporine or tacrolimus(CNI)+Mycophenolate mofetil(MMF)± Short Course Methotrexate(MTX)+Anti-human T-lymphocyte Globulin（ATG）",[9,15],[32],{"name":33,"affiliation":5,"role":34},"Xiaoxia Hu, MD","PRINCIPAL_INVESTIGATOR",[36],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+86 021-64370045","hu_xiaoxia@126.com",{"type":41,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100589042","early-phase-1-a-study-of-imsc-for-the-prevention-of-acute-graft-versus-host-disease-after-allogeneic-hematopoietic-stem-cell-transplantation-100589042",false,"NCT06949267","A Study of iMSC for the Prevention of Acute Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation","A Prospective, Randomized Controlled Study of Human Induced Pluripotent Stem Cell-derived Mesenchymal Stromal Cells (iMSC) for the Prevention of Acute Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation","Inclusion Criteria:\n\n* Subjects with malignant or nonmalignant hematologic diseases 7-21 days after allogeneic hematopoietic stem cell transplantation;\n* No gender restrictions and age between 14-70 years old；\n* Patients received aGVHD prophylaxis regimen of a calcium-modulated phosphatase inhibitor combined with mycophenolate mofetil wtih or without short-course methotrexate and rabbit anti-human thymocyte globulin (CNI+MMF± short-course MTX +ATG)；\n* Patients had a MAGIC algorithm probability (MAP) score ≥ 0.14 at +7d or +14d after allogeneic hematopoietic stem cell transplantation(HSCT) (if patients had a MAP\\\u003C 0.14 at +7d, another test was performed at +14d)；\n* Estimated survival≥ 24 weeks；\n* Eastern Cooperative Oncology Group（ECOG）≤ 2 points and Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI)≤ 3 points；\n* Subjects were be treated within 5 days after enrollment；\n* Informed consent and willingness to participate in the study.\n\nExclusion Criteria:\n\n* Serious organ dysfunction such as organ failure after allogeneic HSCT;\n* Received more than once HSCT (including autologous transplants);\n* Positive for Hepatitis B Surface Antigen (HBsAg) or Hepatitis B Core Antibody (HBcAb) and have Hepatitis B Virus (HBV) DNA titers above the normal range ; positive for Hepatitis C Virus (HCV) antibodies and have positive peripheral blood HCV RNA; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for syphilis;\n* Subjects with severe hepatic veno-occlusive disease or sinus veno-occlusive syndrome;\n* Primary malignant hematologic disease was not remission;\n* Within 6 months prior to enrollment, subjects had other diseases or their physiological conditions may interfere the study results, or had life-threatening complications;\n* Those who are suffering mental or neurological illnesses, unable to express will correctly;\n* Those with active malignant solid tumors within 5 years prior to participation in this study, with the exception of radically treated cervical cancer, in situ limited prostate cancer, and nonmelanoma skin cancer;\n* Subjects known to be potentially allergic or highly sensitized to the cell therapy in the study protocol;\n* Have participated or are participating in another clinical trial within one month prior to enrollment;\n* Those who are judged by the investigator to be unsuitable for participation in this clinical trial.","ALL","14 Years","70 Years",{"count":53,"type":54},56,"ESTIMATED","INTERVENTIONAL",[57],"EARLY_PHASE1","An open-label, randomized, controlled clinical trial to explore the efficacy and safety of iMSC in preventing the development of acute graft-versus-host disease of degree III-IV in patients after allogeneic hematopoietic stem cell transplantation.",[60],"Acute Graft-versus-Host Disease",[23,62,63,64],"III-IV aGVHD","allogeneic hematopoietic stem cell transplantation","prophylaxis","NOT_YET_RECRUITING","2025-04-21",{"date":68,"type":69},"2025-04-29","ACTUAL",{"date":71,"type":54},"2025-06-01",{"date":73,"type":54},"2028-03-31",{"name":5,"class":6}]