[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533666":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":33,"studyPopulation":33,"armGroups":40,"interventions":47,"overallOfficials":53,"centralContacts":57,"locations":33,"responsibleParty":62,"collaborators":33,"id":65,"slug":33,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":33,"eligibilityCriteria":69,"healthyVolunteers":66,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":33,"studyType":76,"phases":77,"briefSummary":78,"conditions":79,"keywords":33,"overallStatus":81,"whyStopped":33,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":33},{"fullName":5,"class":6},"Tianjin Medical University General Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"3 year MS activity free survival","The events for the primary outcome are: clinical relapse, appearance of a new or Gd-enhancing lesion on MRI, or sustained progression of EDSS score.","3 year follow-up post transplant",[14,18,21,24,27,30],{"measure":15,"description":16,"timeFrame":17},"Time to MS treatment failure","Disease activity and disability will be assessed with clinical relapse, appearance of a new or Gd-enhancing lesion on MRI, or sustained progression of EDSS score and quality of life.","3 years",{"measure":19,"description":20,"timeFrame":17},"Transplant related morbidity","Rate of transplant related events.",{"measure":22,"description":23,"timeFrame":17},"Transplant related mortality","Rate of transplant related death.",{"measure":25,"description":26,"timeFrame":17},"Immune reconstitution following transplant","Rate of immune reconstitution following transplant.",{"measure":28,"description":29,"timeFrame":17},"Hematopoietic reconstitution following transplant","Rate of hematopoietic reconstitution following transplant.",{"measure":31,"description":32,"timeFrame":17},"Imaging changes associated with the disease activity","Imaging changes include:\n\nnew or enlarging T2-weighted lesion count and new T1-weighted lesion count at all scans after baseline; T2-weighted lesion volume; Gd-enhanced lesion count and volume; and total volume of non-enhancing T1-weighted lesions on all MRI scans.",null,{"allocation":35,"interventionModel":36,"interventionModelDescription":33,"primaryPurpose":37,"observationalModel":33,"timePerspective":33,"maskingInfo":38},"NA","SINGLE_GROUP","BASIC_SCIENCE",{"masking":39,"maskingDescription":33,"whoMasked":33},"NONE",[41],{"label":42,"type":43,"description":44,"interventionNames":45},"Hematopoietic Stem Cell Transplantation","EXPERIMENTAL","Patients will undergo stem cell transplantation for the treatment of refractory MS",[46],"Procedure: Autologous haemopoietic stem cell transplantation",[48],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":33},"PROCEDURE","Autologous haemopoietic stem cell transplantation","Immuno-ablation and autologous CD34 selected hematopoietic stem cell transplantation (HSCT).\n\nStem cell mobilization with cyclophosphamide 2g\u002Fm2 and filgrastim 10 ug\u002Fkg\u002Fd x 5 day.\n\nStem cell collection with cobe cpectra stem cell purification with Miltenyi CliniMACS Stem cell transplant conditioning with busulphan 3.2 mg\u002Fkg ; fludarabine 30mg\u002Fm2 or cladribine 10mg ；cytarabine 1-2g\u002Fm2 or idarubicin 8mg\u002Fm2；cyclophosphamide 40mg\u002Fkg followed by CD34 selected autologous hematopoietic stem cell transplant.",[42],[54],{"name":55,"affiliation":5,"role":56},"Qiang Liu, M.D.,Ph.D","PRINCIPAL_INVESTIGATOR",[58],{"name":55,"role":59,"phone":60,"phoneExt":33,"email":61},"CONTACT","+86 15022439149","qliu@tmu.edu.cn",{"type":56,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Qiang Liu","Professor of Department of Neurology","100533666",false,"NCT06228781","Autologous Hematopoietic Stem Cell Transplantation for Refractory Multiple Sclerosis","Inclusion Criteria:\n\n1. Age 18-60 years;\n2. Diagnosed multiple sclerosis with relapses or progression and sustained accumulated impairment by a neurologist expert in the field;\n3. EDSS score of 3-6 (including 3 and 6);\n4. EDSS cerebellar functional score ≥ 3 or EDSS pyramidal functional score ≥3；\n5. Evidence of current disease activity;\n6. If a patient has previously received a cytotoxic agent (mitoxantrone, cyclophosphamide etc.) they must have normal bone marrow morphology and cytogenetics before being considered eligible for this study ;\n7. No evidence of hepatic inflammation or fibrosis;\n\nExclusion Criteria:\n\n1. Patients with evidence of myelodysplasia or other non-autoimmune cytopenia;\n2. Patients having received a cytotoxic agent within one month of enrolling in this study;\n3. Patient with any active or chronic infection (herpes simplex virus, varicella-zoster virus, cytomegalovirus, EB virus, human immunodeficiency virus, hepatitis virus, syphilis, etc.);\n4. Patients having received a cytotoxic agent within one month of enrolling in this study;\n5. Patients with a malignant tumor currently or within the last 5 years;\n6. Patients with cardiac, renal, pulmonary, hepatic or other organ impairment;\n7. Patients whose life expectancy is severely limited by another conditions;\n8. Pregnancy or risk of pregnancy;\n9. Patients unable to give written informed consent in accordance with research ethics board guidelines.","ALL","18 Years","60 Years",{"count":74,"type":75},20,"ESTIMATED","INTERVENTIONAL",[35],"Autologous hematopoietic stem cell transplantation (aHSCT) is the only treatment for refractory autoimmune diseases capable of inducing long-term, drug-free and asymptomatic remission. Over the past two decades, aHSCT has been used to treat inflammatory autoimmune disease of the CNS. Patients with relapsing-remitting multiple sclerosis benefit from aHSCT treatment. However, a certain percentage of patients still experience recurrence 3 or 5 years after transplantation. Therefore, exploration of conditioning regimens will drive therapeutic advances in aHSCT in autoimmune diseases of the CNS.",[80],"Multiple Sclerosis","NOT_YET_RECRUITING","2025-05-25",{"date":84,"type":85},"2025-05-30","ACTUAL",{"date":87,"type":75},"2026-12-01",{"date":89,"type":75},"2029-01-01",{"name":5,"class":6}]