Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2026-02-27 @ 10:39 AM
Study NCT ID:
NCT03778333
Status:
COMPLETED
Last Update Posted:
2023-06-01
First Post:
2015-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], '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': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, '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': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-30', 'studyFirstSubmitDate': '2015-01-14', 'studyFirstSubmitQcDate': '2018-12-14', 'lastUpdatePostDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate number of participants with an adverse event related to the treatment.', 'timeFrame': '48 weeks', 'description': 'Adverse events is defined as any untoward or undesirable medical occurence in the form of signs, symptoms, abnormal findings or diseases that emerge during the study period, regardless of causal relationship to the study drug.'}, {'measure': 'To evaluate effects on MS disease activity measured by cumulative number of MRI T2 lesions.', 'timeFrame': '48 weeks', 'description': 'Brain MRI examination'}], 'secondaryOutcomes': [{'measure': 'To evaluate effects on MS disease activity measured by change in EDSS (expanded disability status scale).', 'timeFrame': '48 weeks', 'description': 'EDSS assessed by neurologist.'}, {'measure': 'To evaluate effect on peripheral blood immune cell populations.', 'timeFrame': '24 weeks', 'description': 'Peripheral blood samples.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mesenchymal Stem Cells', 'Multiple Sclerosis'], 'conditions': ['Autologous Mesenchymal Stem Cells', 'Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'To assess the safety of a single dose of IV infusion of bone-marrow derived autologous Mesenchymal Stem Cells (MSCs) in Multiple Sclerosis (MS) with progressive disease status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosis of MS\n\n 1. Active relapsing remitting MS (RRMS) as evidenced by presence of ≥ 1 clinically documented relapse in the past 12 months or ≥2 clinically documented relapses in the last 24 months.\n 2. Secondary progressive MS with clinical progression as evidenced by an increase of 1 EDSS point (or 0,5 p if EDSS ≥ 5 at time for study start) in the last year or evidenced by ≥1 relapse or ≥ GEL at MRI performed within the last year.\n 3. Primary progressive MS with clinical progression as evidenced by an increase of 1 EDSS point (or 0,5 p if EDSS ≥ 5 at time for study start) in the last year.\n2. Age\\_ 18-65 years\n3. Disease duration: 2-20 years\n4. EDSS 3,0-7,0\n\nExclusion Criteria:\n\n1. Subtype of MS not fulfilling inclusion criteria\n2. Treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the 3 months prior to randomization\n3. Treatment with interferon-beta or glatiramer acetate within the 30 days prior to randomization\n4. Treatment with corticosteroids within the 30 days prior to randomization\n5. Relapse occurred during the 60 days prior to randomization\n6. Previous history of a malignancy other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year\n7. Severely limited life expectancy by another co-morbid illness\n8. Active or chronic severe infection.\n9. History of previous diagnosis of myelodysplasia or previous hematologic disease or current clinically relevant abnormalities of white blood cell counts\n10. Pregnancy or risk or pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study)\n11. eGFR \\< 60 mL/min/1.73m2 or known renal failure or inability to undergo MRI examination.\n12. Inability to give written informed consent in accordance with research ethics board guidelines'}, 'identificationModule': {'nctId': 'NCT03778333', 'briefTitle': 'Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden', 'orgStudyIdInfo': {'id': 'MSC-progressive MS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Open label single arm study', 'description': 'All patients will be treated with 1 single dose of IV infusion of autologous bone-marrow derived mesenchymal stem cells (1-2 million cells/kg body weight) and their therapeutic response will be followed over 48 weeks.', 'interventionNames': ['Biological: Autologous mesenchymal stem cells']}], 'interventions': [{'name': 'Autologous mesenchymal stem cells', 'type': 'BIOLOGICAL', 'description': 'IV therapy with autologous bone-marrow derived mesenchymal stem cells', 'armGroupLabels': ['Open label single arm study']}]}, 'contactsLocationsModule': {'locations': [{'zip': '171 76', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institute, Karolinska University Hospital Solna', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}, {'zip': '17176', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institute, Karolinska University Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Lou Brundin', 'investigatorAffiliation': 'Karolinska Institutet'}}}}