Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-27 @ 9:16 PM
Study NCT ID:
NCT06360861
Status:
COMPLETED
Last Update Posted:
2024-04-11
First Post:
2024-03-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluate the Safety and Feasibility of Allogeneic Mesenchymal Stem Cells in Patients With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020528', 'term': 'Multiple Sclerosis, Chronic Progressive'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Open-label phase 1, single-center, pre-post comparison study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-07', 'studyFirstSubmitDate': '2024-03-17', 'studyFirstSubmitQcDate': '2024-04-07', 'lastUpdatePostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Treatment-Emergent Adverse Events [Safety and Tolerability].', 'timeFrame': 'Up to 6 months', 'description': 'adverse events'}], 'secondaryOutcomes': [{'measure': 'Number of participants with a change in disability as measured by Expanded Disability Status Scale .', 'timeFrame': 'Up to 6 months', 'description': 'Proportion of patients with clinical improvement in EDSS score compared to baseline. EDSS scores range from 0 = no disability to 10 = death due to MS and higher scores mean a worse outcome.'}, {'measure': 'Number of participants with a change in cognitive function as measured by the Paced Auditory Serial Addition Test .', 'timeFrame': 'Up to 6 months', 'description': 'The minimum score is 0 and maximum score is 60, and higher scores mean a better outcome.'}, {'measure': 'Number of participants with a change in cognitive performance as measured by Persian version of minimal assessment of cognitive function in MS battery.', 'timeFrame': 'Up to 6 months', 'description': 'Assessment of cognitive function'}, {'measure': 'Number of participants with a change in brain connectivity as measured by Functional magnetic resonance imaging .', 'timeFrame': 'Up to 6 months', 'description': 'Assessment of brain connectivity'}, {'measure': 'Number of participants with a change in white matter integrity as measured by quantitative diffusion tensor imaging .', 'timeFrame': 'Up to 6 months', 'description': 'Change from baseline in white matter integrity'}, {'measure': 'Number of participants with a change in processing and motor speed as assessed by the Symbol Digit Modalities Test .', 'timeFrame': 'Up to 6 months', 'description': 'Change from baseline in processing and motor speed of patients and higher scores mean a better outcome.'}, {'measure': 'Number of participants with evaluation of verbal learning and memory deficits as measured by the California Verbal Learning Test second edition .', 'timeFrame': 'Up to 6 months', 'description': 'Change from baseline in verbal learning and memory deficits and higher scores mean a better outcome.'}, {'measure': 'Proportion of patients with change in CD20 / CD19 B cells surface markers', 'timeFrame': 'Up to 3 months', 'description': 'Blood samples will be collected pre and post treatment for immediate or ulterior analysis.'}, {'measure': 'Biological Assessments including IL-10, IL-6, IL-17, and TNFα levels of cytokines.', 'timeFrame': 'Up to 3 months', 'description': 'Blood samples will be collected pre and post treatment for immediate or ulterior analysis.'}, {'measure': 'Proportion of patients with change in T2 lesion volume on brain MRI.', 'timeFrame': 'Up to 6 months', 'description': 'Change from baseline in T2 lesion volume.'}, {'measure': 'Proportion of patients with change in brain volume on MRI.', 'timeFrame': 'Up to 6 months', 'description': 'Change from baseline in brain volume'}, {'measure': 'Proportion of patients for assessment of visuospatial learning as measured by the Brief Visuospatial Memory Test-Revised .', 'timeFrame': 'Up to 6 months', 'description': 'Change from baseline in visuospatial learning'}, {'measure': 'Proportion of patients for assessment of visuospatial ability as measured by Judgment of Line Orientation Test .', 'timeFrame': 'Up to 6 months', 'description': 'Change from baseline in visuospatial ability'}, {'measure': 'Proportion of patients for evaluation of executive functions as measured by the Delis-Kaplan Executive Function System Sorting and descriptive tests.', 'timeFrame': 'Up to 6 months', 'description': 'Change from baseline in executive functions'}, {'measure': 'Proportion of patients for measuring verbal fluency as measured by the Controlled Oral Word Association Test .', 'timeFrame': 'Up to 6 months', 'description': 'Change from baseline in measuring verbal fluency'}, {'measure': 'Proportion of patients for psychological assessment as measured by the validated Persian version of Symptom Checklist-90-Revised .', 'timeFrame': 'Up to 6 months', 'description': 'Symptom Checklist-90(SCL-90) is a collection of nine subscales (with 90 items) for evaluation of Somatization, Obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism in the past week. Each item has a 5-point Likert scale and scoring from 0 to 4. SCL-90 Global Severity was calculated by dividing the sum of all subscales scores by 9.'}, {'measure': 'Proportion of patients for evaluation of fatigue as measured by was examined by the Persian version of Fatigue Severity Scale .', 'timeFrame': 'Up to 6 months', 'description': 'Fatigue Severity Scale(FSS )is a scale with 9 items, which assesses the fatigue severity in the past 2 weeks. Each item has a score from 1 to 7 and total score will be from 9 to 63. Higher FSS score indicates higher fatigue severity.'}, {'measure': 'Proportion of patients for assessment of visuospatial ability as measured by the brief visuospatial memory test-revised test.', 'timeFrame': 'Up to 6 months', 'description': 'Change from baseline in visuospatial ability'}, {'measure': 'Proportion of patients for assessment of visuospatial ability as measured by the California Verbal Learning Test Second Edition test.', 'timeFrame': 'Up to 6 months', 'description': 'Change from baseline in visuospatial ability'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mesenchymal Stem cells', 'Multiple Sclerosis', 'Placenta derived Mesenchymal Stem Cells', 'Stem Cell therapy', 'Neuroimmunology', 'Autoimmune Disease'], 'conditions': ['Multiple Sclerosis', 'Secondary-Progressive Multiple Sclerosis', 'Mesenchymal Stem Cells']}, 'referencesModule': {'references': [{'pmid': '34256857', 'type': 'BACKGROUND', 'citation': 'Shokati A, Naser Moghadasi A, Nikbakht M, Sahraian MA, Mousavi SA, Ai J. A focus on allogeneic mesenchymal stromal cells as a versatile therapeutic tool for treating multiple sclerosis. Stem Cell Res Ther. 2021 Jul 13;12(1):400. doi: 10.1186/s13287-021-02477-5.'}, {'pmid': '32504294', 'type': 'BACKGROUND', 'citation': 'Ebrahimi-Barough S, Ai J, Payab M, Alavi-Moghadam S, Shokati A, Aghayan HR, Larijani B, Arjmand B. Standard Operating Procedure for the Good Manufacturing Practice-Compliant Production of Human Endometrial Stem Cells for Multiple Sclerosis. Methods Mol Biol. 2021;2286:199-212. doi: 10.1007/7651_2020_281.'}]}, '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.\n\nMonitoring 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.', 'detailedDescription': "This open-label phase I study will be conducted in MS Clinic of Sina and Shariati Hospital of Tehran province .\n\nIn this study, diagnosis and management of MS patients will be performed based on McDonald's criteria and Iran's diagnostic and treatment protocols.\n\nThe patients will be received a single injection of PLMSCs through the intravenous cannula.\n\nThe proposed study will assess safety and short efficacy endpoints of PLMSCs administered to 5 patients with SPMS.\n\nThe primary objective of the trial is freedom from treatment associated adverse events at 1,3 and 6 months' post treatment. Secondary objective will be efficacy as assessed at baseline, at 1,3 and 6 months and will be based on the following: EDSS, cytokines, DTI, fMRI, cognitive \\& psychological evaluations, and flow cytometry for B cell markers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Criteria:\n\nInclusion Criteria:\n\n* Age between 17-45 years Patients with SPMS .\n* Must be able to Sign informed consent .\n* Currently taking Rituximab.\n* Disease duration of more than 2 and less than 16 years.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n* hepatitis B and C, human immunodeficiency virus (HIV), and human T-cell lymphotropic virus (HTLV) disease.\n* Using cytotoxic agents within 3 months prior to the study.\n* Severe anemia (hemoglobin\\< 8 mg/dl), coagulation disorders.\n* history of malignancy .\n* liver disorders .\n* significant cardiac, renal or hepatic failure .\n* Active or chronic infection.\n* Life-threatening organ dysfunction.\n* Unable to give written informed consent .\n* Current treatment with an investigational therapy.'}, 'identificationModule': {'nctId': 'NCT06360861', 'acronym': 'MS', 'briefTitle': 'Evaluate the Safety and Feasibility of Allogeneic Mesenchymal Stem Cells in Patients With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Tehran University of Medical Sciences'}, 'officialTitle': 'An Open-label, Non-randomized, Phase I Study of Allogeneic Placenta Derived Mesenchymal Stem Cells in Patients With Secondary-Progressive Multiple Sclerosis (SPMS),', 'orgStudyIdInfo': {'id': '1400-1-233-51589'}, 'secondaryIdInfos': [{'id': 'IR.TUMS.MEDICINE.REC.1400.197', 'type': 'OTHER_GRANT', 'domain': 'Tehran University of Medical Sciences'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Placenta derived mesenchymal cells', 'description': 'Allogenic placenta derived mesenchymal stem cells, 3 million cells/kg body weight via intravenous injection', 'interventionNames': ['Biological: Allogenic placenta derived mesenchymal stem cells']}], 'interventions': [{'name': 'Allogenic placenta derived mesenchymal stem cells', 'type': 'BIOLOGICAL', 'description': 'Allogenic placenta derived mesenchymal stem cells, 3 million cells/kg body weight via intravenous injection.', 'armGroupLabels': ['Placenta derived mesenchymal cells']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'country': 'Iran', 'facility': 'Tehran University of Medical Sciences,Tehran, Iran', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Abdorreza Naser Moghadasi, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Multiple Sclerosis Research Center,Neuroscience Institute,Sina Hospital,Tehran, Iran.'}, {'name': 'Mohsen Nikbakht, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Research Institute for Oncology, Hematology& Cell Therapy Facility, Shariati Hospital ,Tehran, Iran.'}, {'name': 'Ameneh Shokati, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Applied Cell Sciences,Tehran University of Medical Sciences,Tehran, Iran.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tehran University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}