Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-02-12 @ 4:48 PM
Study NCT ID:
NCT02241395
Status:
WITHDRAWN
Last Update Posted:
2018-10-25
First Post:
2014-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cell Therapy as Treatment for Cerebral Palsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002547', 'term': 'Cerebral Palsy'}], 'ancestors': [{'id': 'D001925', 'term': 'Brain Damage, Chronic'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, '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'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-10-23', 'studyFirstSubmitDate': '2014-09-12', 'studyFirstSubmitQcDate': '2014-09-15', 'lastUpdatePostDateStruct': {'date': '2018-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in clinical symptoms over a period of 2 years', 'timeFrame': '2 years', 'description': 'Clinical symptoms such as oromotor skills, sitting and standing balance, speech, ambulation, muscle tone, cognition, hand and leg movement, walking, etc'}], 'secondaryOutcomes': [{'measure': 'Change in GMFM score', 'timeFrame': '1 year'}, {'measure': 'Change in Gross Motor Function Measure', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cerebral Palsy', 'autologous bone marrow mononuclear cells', 'stem cell'], 'conditions': ['Cerebral Palsy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to study the effect of autologous bone marrow mononuclear cells on common symptoms of cerebral palsy patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed cases of any type of Cerebral Palsy\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.'}, 'identificationModule': {'nctId': 'NCT02241395', 'briefTitle': 'Cell Therapy as Treatment for Cerebral Palsy', 'organization': {'class': 'OTHER', 'fullName': 'Neurogen Brain and Spine Institute'}, 'officialTitle': 'Autologous Bone Marrow Mononuclear Cell Therapy in Cerebral Palsy', 'orgStudyIdInfo': {'id': 'NGBSI-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stem Cell', 'description': 'Intrathecal autologous bone marrow mononuclear cell transplantation', 'interventionNames': ['Biological: Intrathecal autologous bone marrow mononuclear cell transplantation']}], 'interventions': [{'name': 'Intrathecal autologous bone marrow mononuclear cell transplantation', 'type': 'BIOLOGICAL', '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'}}}}