Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-01-24 @ 10:35 PM
Study NCT ID:
NCT02116634
Status:
WITHDRAWN
Last Update Posted:
2016-01-14
First Post:
2014-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mesenchymal Stem Cell Injection in Amyotrophic Lateral Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000690', 'term': 'Amyotrophic Lateral Sclerosis'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Because economic problems', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-13', 'studyFirstSubmitDate': '2014-04-06', 'studyFirstSubmitQcDate': '2014-04-16', 'lastUpdatePostDateStruct': {'date': '2016-01-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of Intrathecal injection of autologous mesenchymal stem cells in improving the symptoms of ALS', 'timeFrame': 'every 6 months up 2 years after transplantation'}], 'secondaryOutcomes': [{'measure': 'ALS-FRS(functional rating scale) score and EMG scale', 'timeFrame': 'before transplatation and at 6 months, 12months, 18 months and 24 months after transplantation'}, {'measure': 'FVC (forced vital capacity)and DWSE±QoL score', 'timeFrame': 'before transplantation and every 6 months up 2 years after transplantation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Amyotrophic Lateral Sclerosis']}, 'descriptionModule': {'briefSummary': 'Whether the mesenchymal injection on ALS patients is effective or not?', 'detailedDescription': 'After and before transplantation, all of the patients will visit by experience neurologist and evaluate with EMG (electromyography) and spirometry procedure and clinical progression of disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. sporadic ALS according to escorial criteria\n2. onset of disease with spinal cord involvement, Less than 3 years of disease onset with disease progression at 6 past months\n3. mild to moderate spinal and bulbar disability,at least having score3 in swallowing, 2 in chewing and waking in ALS-FRS and FVC(functional vital capacity) equal or more than 50% of prediction amount\n4. normal polysomnography\n5. Signed consent form\n\nExclusion Criteria:\n\n1. pregnancy or lactation,\n2. vascular disease,diabetes, systemic disease as cancer, autoimmune , liver or hematologic disease\n3. Hospitalization due to serious illness in the last two months\n4. survival time less than two years\n5. Hypersensitivity to any component used in the cell culture'}, 'identificationModule': {'nctId': 'NCT02116634', 'briefTitle': 'Mesenchymal Stem Cell Injection in Amyotrophic Lateral Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Alzahra Hospital, Iran'}, 'officialTitle': 'Phase 1, 2 Study of Mesenchymal Stem Cells Injection in ALS (Amyotrophic Lateral Sclerosis) Patients', 'orgStudyIdInfo': {'id': 'rokhsareh'}, 'secondaryIdInfos': [{'id': 'stem cell injection in ALS', 'type': 'OTHER', 'domain': 'iran national science foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mesenchymal stem cell', 'description': 'intra spinal injection of 1 ×10(8) mesenchymal stem cells +10cc normal saline', 'interventionNames': ['Biological: mesenchymal stem cell']}], 'interventions': [{'name': 'mesenchymal stem cell', 'type': 'BIOLOGICAL', 'description': 'intra spinal injection of 1 ×10(8) mesenchymal stem cells +10cc normal saline', 'armGroupLabels': ['mesenchymal stem cell']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0098311', 'city': 'Isfahan', 'country': 'Iran', 'facility': 'Neurosciences Research Center', 'geoPoint': {'lat': 32.65246, 'lon': 51.67462}}], 'overallOfficials': [{'name': 'keivan basiri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Isfahan neurosciences research center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alzahra Hospital, Iran', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'rokhsareh meamar', 'investigatorAffiliation': 'Alzahra Hospital, Iran'}}}}