protocolSection identificationModule nctId: NCT06360861, orgStudyIdInfo id: 1400-1-233-51589, secondaryIdInfos id: IR.TUMS.MEDICINE.REC.1400.197, type: OTHER_GRANT, domain: Tehran University of Medical Sciences, briefTitle: Evaluate the Safety and Feasibility of Allogeneic Mesenchymal Stem Cells in Patients With Multiple Sclerosis, acronym: MS, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-07-23, primaryCompletionDateStruct date: 2024-03-04, completionDateStruct date: 2024-03-06, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Tehran University of Medical Sciences, class: OTHER, descriptionModule briefSummary: To assess the safety and of a single dose of IV infusion of placenta derived Mesenchymal Stem Cells (PLMSCs) in patients with secondary progressive Multiple Sclerosis (SPMS) disease.Monitoring will be encompassed baseline assessments and follow-ups over subsequent months, evaluating clinical signs, Expanded Disability Status Scale (EDSS), cytokines, diffusion tensor imaging (DTI), functional MRI (fMRI), cognitive \& psychological evaluations, and flow cytometry for B cell markers., conditionsModule conditions: Multiple Sclerosis, conditions: Secondary-Progressive Multiple Sclerosis, conditions: Mesenchymal Stem Cells, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Open-label phase 1, single-center, pre-post comparison study, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ACTUAL, armsInterventionsModule interventions name: Allogenic placenta derived mesenchymal stem cells, outcomesModule primaryOutcomes measure: Number of participants with Treatment-Emergent Adverse Events [Safety and Tolerability]., secondaryOutcomes measure: Number of participants with a change in disability as measured by Expanded Disability Status Scale ., secondaryOutcomes measure: Number of participants with a change in cognitive function as measured by the Paced Auditory Serial Addition Test ., secondaryOutcomes measure: Number of participants with a change in cognitive performance as measured by Persian version of minimal assessment of cognitive function in MS battery., secondaryOutcomes measure: Number of participants with a change in brain connectivity as measured by Functional magnetic resonance imaging ., secondaryOutcomes measure: Number of participants with a change in white matter integrity as measured by quantitative diffusion tensor imaging ., secondaryOutcomes measure: Number of participants with a change in processing and motor speed as assessed by the Symbol Digit Modalities Test ., secondaryOutcomes measure: Number of participants with evaluation of verbal learning and memory deficits as measured by the California Verbal Learning Test second edition ., secondaryOutcomes measure: Proportion of patients with change in CD20 / CD19 B cells surface markers, secondaryOutcomes measure: Biological Assessments including IL-10, IL-6, IL-17, and TNFα levels of cytokines., secondaryOutcomes measure: Proportion of patients with change in T2 lesion volume on brain MRI., secondaryOutcomes measure: Proportion of patients with change in brain volume on MRI., secondaryOutcomes measure: Proportion of patients for assessment of visuospatial learning as measured by the Brief Visuospatial Memory Test-Revised ., secondaryOutcomes measure: Proportion of patients for assessment of visuospatial ability as measured by Judgment of Line Orientation Test ., secondaryOutcomes measure: Proportion of patients for evaluation of executive functions as measured by the Delis-Kaplan Executive Function System Sorting and descriptive tests., secondaryOutcomes measure: Proportion of patients for measuring verbal fluency as measured by the Controlled Oral Word Association Test ., secondaryOutcomes measure: Proportion of patients for psychological assessment as measured by the validated Persian version of Symptom Checklist-90-Revised ., secondaryOutcomes measure: Proportion of patients for evaluation of fatigue as measured by was examined by the Persian version of Fatigue Severity Scale ., secondaryOutcomes measure: Proportion of patients for assessment of visuospatial ability as measured by the brief visuospatial memory test-revised test., secondaryOutcomes measure: Proportion of patients for assessment of visuospatial ability as measured by the California Verbal Learning Test Second Edition test., eligibilityModule sex: ALL, minimumAge: 17 Years, maximumAge: 45 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Tehran University of Medical Sciences,Tehran, Iran, city: Tehran, country: Iran, Islamic Republic of, geoPoint lat: 35.69439, lon: 51.42151, hasResults: False