Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-21 @ 11:45 AM
Study NCT ID:
NCT02028104
Status:
WITHDRAWN
Last Update Posted:
2018-10-25
First Post:
2014-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Stem Cell Therapy in Traumatic Brain Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070642', 'term': 'Brain Injuries, Traumatic'}], 'ancestors': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, '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'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-23', 'studyFirstSubmitDate': '2014-01-03', 'studyFirstSubmitQcDate': '2014-01-03', 'lastUpdatePostDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'SF-8 scale', 'timeFrame': '6 months'}], 'primaryOutcomes': [{'measure': 'Change in clinical symptoms of traumatic brain injury', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Disability Rating scale', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Traumatic Brain Injury']}, 'referencesModule': {'references': [{'pmid': '23180314', 'type': 'BACKGROUND', 'citation': 'Lee DH, Lee JY, Oh BM, Phi JH, Kim SK, Bang MS, Kim SU, Wang KC. Functional recovery after injury of motor cortex in rats: effects of rehabilitation and stem cell transplantation in a traumatic brain injury model of cortical resection. Childs Nerv Syst. 2013 Mar;29(3):403-11. doi: 10.1007/s00381-012-1969-4. Epub 2012 Nov 24.'}, {'pmid': '22891928', 'type': 'BACKGROUND', 'citation': 'Tian C, Wang X, Wang X, Wang L, Wang X, Wu S, Wan Z. Autologous bone marrow mesenchymal stem cell therapy in the subacute stage of traumatic brain injury by lumbar puncture. Exp Clin Transplant. 2013 Apr;11(2):176-81. doi: 10.6002/ect.2012.0053. Epub 2012 Aug 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to study the effect of stem cell therapy on common symptoms in patients with Traumatic Brain Injury'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed cases of chronic traumatic brain injury\n* Age above 6 months\n\nExclusion Criteria:\n\n* presence of acute infections such as Human immunodeficiency virus/Hepatitis B - Virus/Hepatitis C Virus\n* malignancies\n* bleeding tendencies\n* pneumonia\n* renal failure\n* severe liver dysfunction\n* severe anemia \\[Hemoglobin \\< 8\\]\n* any bone marrow disorder\n* space occupying lesion in brain\n* other acute medical conditions such as respiratory infection and pyrexia\n* pregnancy\n* lactation'}, 'identificationModule': {'nctId': 'NCT02028104', 'briefTitle': 'Stem Cell Therapy in Traumatic Brain Injury', 'organization': {'class': 'OTHER', 'fullName': 'Neurogen Brain and Spine Institute'}, 'officialTitle': 'Open Label Study of Autologous Bone Marrow Mononuclear Cells in Traumatic Brain Injury', 'orgStudyIdInfo': {'id': 'NGBSI-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'stem cells', 'description': 'autologous bone marrow mononuclear cell transplantation', 'interventionNames': ['Biological: Autologous bone marrow mononuclear cell transplantation']}], 'interventions': [{'name': 'Autologous bone marrow mononuclear cell transplantation', 'type': 'BIOLOGICAL', 'description': 'bone marrow derived mononuclear cells are administered intrathecally in traumatic brain injury patients', 'armGroupLabels': ['stem cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400071', 'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Neurogen brain and spine institute', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}], 'overallOfficials': [{'name': 'Alok K Sharma, M.S., M.Ch', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Neurogen Brain and Spine Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurogen Brain and Spine Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}