Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-28 @ 4:50 PM
Study NCT ID:
NCT01228266
Status:
TERMINATED
Last Update Posted:
2014-02-13
First Post:
2010-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mesenchymal Stem Cell Transplantation in MS
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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'whyStopped': 'Ended the recruitment in June 2012 for low enrollement accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-12', 'studyFirstSubmitDate': '2010-10-25', 'studyFirstSubmitQcDate': '2010-10-25', 'lastUpdatePostDateStruct': {'date': '2014-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety as number of severe events along 1 year, and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI at 6 months and at the end of the study', 'timeFrame': '12 months', 'description': 'The coprimary endpoints were safety and efficacy in terms of cumulative number of gadolinium-enhancing lesions in MRI'}], 'secondaryOutcomes': [{'measure': 'To evaluate effects on MS disease activity measured by: clinical variables, MRI, OCT, immunological analysis and quality of life scales', 'timeFrame': '12 months', 'description': 'clinical outcomes (number of relapses and change in the EDSS); MRI-based measures and OCT. Immunological evaluation as exploratory analysis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Multiple Sclerosis'], 'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '25436769', 'type': 'DERIVED', 'citation': 'Llufriu S, Sepulveda M, Blanco Y, Marin P, Moreno B, Berenguer J, Gabilondo I, Martinez-Heras E, Sola-Valls N, Arnaiz JA, Andreu EJ, Fernandez B, Bullich S, Sanchez-Dalmau B, Graus F, Villoslada P, Saiz A. Randomized placebo-controlled phase II trial of autologous mesenchymal stem cells in multiple sclerosis. PLoS One. 2014 Dec 1;9(12):e113936. doi: 10.1371/journal.pone.0113936. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'The study is a randomized Phase II study, masked and crossed-over with placebo to evaluate the safety and tolerability of autologous mesenchymal stem cell transplantation in patients with active multiple sclerosis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Inflammatory forms of MS\n\n 1. Relapsing-remitting MS (RRMS) patients\n 2. Secondary progressive MS (SPMS) patients with continued relapses\n 3. Primary progressive MS (PPMS) patients with enhancing MRI lesions and positive CSF (oligoclonal banding)\n2. Age 18-50 years\n3. Disease duration \\>= 2 and \\>= 10 years\n4. EDSS 3.0 - 6.5\n5. Progression, continued relapses or worsening MRI after at least a year of attempted therapy evidenced by:\n\n 1. Increase of \\>= 1 EDSS point (if baseline EDSS \\<= 5.0) or 0.5 EDSS points (if baseline EDSS \\>= 5.5), or quantifiable, objective evidence of equivalent progression\n 2. \\>= 1 moderate-severe relapses in past 18 months\n 3. \\>= 1 Gadolinium enhancing lesions (double or triple dose Gadolinium)\n 4. \\>= 1 new T2 lesion\n 5. For PPMS only, \\>= 1 Gadolinium enhancing lesions\n6. Has given informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. SPMS without ongoing relapses\n2. PPMS without positive CSF or Gadolinium enhancing lesions\n3. \\<= 3 months since treatment with any immunosuppressive therapy\n4. \\<=1 month since last treatment with interferon-B or glatiramer acetate\n5. Corticosteroid treatment \\<= 30 days\n6. Relapse \\<= 60 days\n7. History of cancer or clinical or laboratory results indicative of severe systemic diseases, including infection for HIV, Hepatitis B or C\n8. Any metallic or electronic device that precludes from undergoing MRI\n9. Pregnancy or lactation\n10. Current treatment with an investigational therapy'}, 'identificationModule': {'nctId': 'NCT01228266', 'acronym': 'CMM-EM', 'briefTitle': 'Mesenchymal Stem Cell Transplantation in MS', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Clinic of Barcelona'}, 'officialTitle': 'Autologous Mesenchymal Stem Cell Transplantation in Multiple Sclerosis: a Randomized, Double-blind, Crossover With Placebo Phase II Study', 'orgStudyIdInfo': {'id': 'CMM-EM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'autologous mesenchymal stem cell', 'description': 'A single infusion of up to 2 million cells per Kg of autologous mesenchymal stem cells vs suspension media. The treatment will be reversed at 6 months', 'interventionNames': ['Biological: autologous mesenchymal stem cells']}], 'interventions': [{'name': 'autologous mesenchymal stem cells', 'type': 'BIOLOGICAL', 'description': 'A randomized double-blind, crossover study comparing treatment with autologous MSC vs. suspension media on patients with active MS', 'armGroupLabels': ['autologous mesenchymal stem cell']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08036', 'city': 'Barcelona', 'state': 'Barcelona', 'country': 'Spain', 'facility': 'Neurology Service, Hospital Clinic de barcelona', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'overallOfficials': [{'name': 'Albert Saiz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Clinic of Barcelona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Albert Saiz', 'class': 'OTHER'}, 'collaborators': [{'name': 'Instituto de Salud Carlos III', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Albert Saiz', 'investigatorAffiliation': 'Hospital Clinic of Barcelona'}}}}