Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2026-03-03 @ 6:36 AM
Study NCT ID:
NCT02564328
Status:
UNKNOWN
Last Update Posted:
2015-09-30
First Post:
2015-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-29', 'studyFirstSubmitDate': '2015-09-29', 'studyFirstSubmitQcDate': '2015-09-29', 'lastUpdatePostDateStruct': {'date': '2015-09-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in Fugl-Meyer Scale at 12 months', 'timeFrame': '1,3,6 and 12 months'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in NIH Stroke Scale at 12 months', 'timeFrame': '1,3,6 and 12 months'}, {'measure': 'Change from baseline in Barthel Index at 12 months', 'timeFrame': '1,3,6 and 12 months'}, {'measure': 'Change from baseline in SSS at 12 months', 'timeFrame': '1,3,6 and 12 months'}, {'measure': 'Change from baseline in mRS at 12 months', 'timeFrame': '1,3,6 and 12 months'}, {'measure': 'Improvement of vision measured by brain visual examination', 'timeFrame': '1,6 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stroke', 'Bone Marrow Mesenchymal Stem Cell', 'Transplantation'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.Stem cell transplantation provides a promising approach for rehabilitation. The main objective of this study is to evaluate the efficacy and safy of the transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic stroke.', 'detailedDescription': 'Stroke is a frequently occurring and common diseases in nervous system,and most of the survivors will remain disorders of motor,sensory and cognition function.It will brought heavy burden to patients themselves,their family and society.Drugs,rehabilitation excise and hyperbaric oxygen will improve functions after acute stroke.However,in the chronic ischemic stroke,there was few methods to improve the functions.In recently research,stem cell will be a new methods to improve the neural function after through differentiate to nervous cells and secrete some neurotrophic factors to repair the damage. In this study, the investigators will assess the safety and feasibility of intracerebral transplantation of autologous bone marrow mesenchymal stem cells in patients with chronic ischemic stroke. The neurological outcome will be determined after transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Aged 18-80 chronic ischemia stroke or patients\n* With stroke history of more than 6 months, less than 60 months\n* NIHSS (NIH stroke scale) score of 7 or more points\n* Internal carotid artery territory infarction measured by MRI\n* Can be hospitalized and signed informed consent\n* With fewer effect by traditional post-stroke treatments or rehabilitations\n\nExclusion Criteria:\n\n* Lacunar infarction\n* Recurrent thrombotic diseases less than 6 months\n* Hemorrhage stroke,brain tumor or MRI show the occlusion is not in the middle cerebral artery territory\n* Pregnant women\n* Can't tolerate the test because of other disease, such as heart failure, liver failure, renal failure, abnormal blood coagulation, AIDS, combine other tumor or special condition\n* Penicillin anaphylaxis or some other drugs allergy\n* Autoimmune disease\n* Inaccessibility for follow up"}, 'identificationModule': {'nctId': 'NCT02564328', 'briefTitle': 'Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Southern Medical University, China'}, 'officialTitle': 'Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Ischemic Stroke', 'orgStudyIdInfo': {'id': '201400000003-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous stem cell transplantation', 'description': 'Intravenous transplantation of autologous bone marrow mesenchymal stem cell plus conventional treatment include rehabilitation', 'interventionNames': ['Genetic: Intravenous stem cell transplantation']}, {'type': 'NO_INTERVENTION', 'label': 'Conventional treatment', 'description': 'Control group receive conventional stroke treatment that include rehabilitation'}], 'interventions': [{'name': 'Intravenous stem cell transplantation', 'type': 'GENETIC', 'description': 'Intravenous injection of autologous bone marrow mesenchymal stem cell transplantation', 'armGroupLabels': ['Intravenous stem cell transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510282', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaodan Jiang, MD,PhD', 'role': 'CONTACT', 'email': 'jiangxiao_dan@163.com', 'phone': '86 20 61643268'}, {'name': 'Xiaodan Jiang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Xiaodan Jiang', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Xiaodan Jiang, MD,PhD', 'role': 'CONTACT', 'email': 'jiangxiao_dan@163.com', 'phone': '86 20 61643268'}], 'overallOfficials': [{'name': 'Xiaodan Jiang, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Southern Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Southern Medical University, China', 'class': 'OTHER'}, 'collaborators': [{'name': 'Second Affiliated Hospital of Guangzhou Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Zhujiang Hospital,Southern Medical University, China', 'investigatorFullName': 'Xiaodan Jiang', 'investigatorAffiliation': 'Southern Medical University, China'}}}}