Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-30 @ 7:54 PM
Study NCT ID:
NCT02241434
Status:
WITHDRAWN
Last Update Posted:
2018-10-25
First Post:
2014-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stem Cell Therapy in Duchenne Muscular Dystrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020388', 'term': 'Muscular Dystrophy, Duchenne'}], 'ancestors': [{'id': 'D009136', 'term': 'Muscular Dystrophies'}, {'id': 'D020966', 'term': 'Muscular Disorders, Atrophic'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-23', 'studyFirstSubmitDate': '2014-09-12', 'studyFirstSubmitQcDate': '2014-09-12', 'lastUpdatePostDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Manual Muscle Testing', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Brooke and Vignos Scale', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Duchenne muscular dystrophy', 'Autologous Bone marrow Mononuclear cell therapy', 'Stem Cells'], 'conditions': ['Duchenne Muscular Dystrophy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to study the effect of stem cell therapy in patients with Duchenne Muscular Dystrophy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '25 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age group of 3-25 years\n* Duchenne muscular dystrophy diagnosed on the basis of clinical presentation\n\nExclusion Criteria:\n\n* presence of respiratory distress\n* presence of acute infections such as Human Immunodeficient Virus/Hepatitis B Virus/Hepatitis C Virus\n* malignancies\n* acute medical conditions such as respiratory infection, fever, hemoglobin less than 8, bleeding tendency, bone marrow disorder, left ventricular ejection fraction \\< 30%\n* pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT02241434', 'briefTitle': 'Stem Cell Therapy in Duchenne Muscular Dystrophy', 'organization': {'class': 'OTHER', 'fullName': 'Neurogen Brain and Spine Institute'}, 'officialTitle': 'The Role of Autologous Bone Marrow Mononuclear Cell Therapy in Duchenne Muscular Dystrophy', 'orgStudyIdInfo': {'id': 'NGBSI-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stem Cell', 'description': 'bone marrow mononuclear cell transplantation', 'interventionNames': ['Biological: Stem Cell']}], 'interventions': [{'name': 'Stem Cell', 'type': 'BIOLOGICAL', 'description': 'Intrathecal autologous bone marrow mononuclear cell transplantation', 'armGroupLabels': ['Stem Cell']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400706', 'city': 'Navi Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Neurogen brain and spine institute', 'geoPoint': {'lat': 19.03681, 'lon': 73.01582}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurogen Brain and Spine Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}