Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-02-21 @ 9:56 PM
Study NCT ID:
NCT03291366
Status:
UNKNOWN
Last Update Posted:
2017-09-25
First Post:
2017-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mesenchymal Stem Cells in Central Nervous System injury2017
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-20', 'studyFirstSubmitDate': '2017-09-20', 'studyFirstSubmitQcDate': '2017-09-20', 'lastUpdatePostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'life quality score', 'timeFrame': '1y'}], 'secondaryOutcomes': [{'measure': 'adverse events', 'timeFrame': '1y'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Central Nervous System Injury']}, 'descriptionModule': {'briefSummary': 'Central nervous system (CNS) injury leads to morbidity in patients, which has few good rehabilitation measures. Mesenchymal stem cells seem to have regenerative and tissue-repairing capabilities. The investigators design this study to infuse mesenchymal stem cells (MSCs) intrathecally to CNS injury patients, and observe the safety and efficacy by recording the change of nervous system scores, trying to prove the effect of MSC in rehabilitate CNS injury.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CNS injury \\> 3 months\n* age \\> 18 years\n* willing to give consent\n* stable vital signs\n* absence of active infectcion\n\nExclusion Criteria:\n\n* any contradiction to intrathecal infusion\n* age \\< 18 years\n* CNS injury \\< 3 months\n* CNS injury \\> 3 years'}, 'identificationModule': {'nctId': 'NCT03291366', 'briefTitle': 'Mesenchymal Stem Cells in Central Nervous System injury2017', 'organization': {'class': 'OTHER', 'fullName': 'Fuzhou General Hospital'}, 'officialTitle': 'Intrathecal Injection of Mesenchymal Stem Cells in Central Nervous System injury2017', 'orgStudyIdInfo': {'id': 'MSC-CNS2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MSC', 'description': 'infusion of aUCMSC and conventional therapy', 'interventionNames': ['Drug: UCMSCC', 'Drug: conventional treatment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional', 'description': 'conventional therapy', 'interventionNames': ['Drug: conventional treatment']}], 'interventions': [{'name': 'UCMSCC', 'type': 'DRUG', 'description': 'infusion of aUCMSC and conventional therapy', 'armGroupLabels': ['MSC']}, {'name': 'conventional treatment', 'type': 'DRUG', 'description': 'conventional treatment', 'armGroupLabels': ['MSC', 'conventional']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fuzhou General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jianming Tan', 'investigatorAffiliation': 'Fuzhou General Hospital'}}}}