Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2026-02-22 @ 4:52 PM
Study NCT ID:
NCT01714167
Status:
UNKNOWN
Last Update Posted:
2015-06-08
First Post:
2012-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D002543', 'term': 'Cerebral Hemorrhage'}], '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'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-04', 'studyFirstSubmitDate': '2012-10-19', 'studyFirstSubmitQcDate': '2012-10-22', 'lastUpdatePostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in NIH Stroke Scale at 12 months', 'timeFrame': '1, 6 and 12 months'}], 'secondaryOutcomes': [{'measure': 'Improvement of infarct size measured by brain MRI', 'timeFrame': '1,6 and 12 months after transplantation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic', 'Ischemic Stroke', 'Intracerebral Hemorrhage', 'Bone Marrow Mesenchymal Stem Cell'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Stroke is one of the leading causes of disability in the world, and stem cell - transplantation provides a promising approach for rehabilitation. The main objective of this study is to evaluate the efficacy of the intracerebral injection of autologous bone marrow mesenchymal stem cells in patients with chronic stroke.', 'detailedDescription': 'For many stroke survivors, the best hope is a lengthy program of rehabilitation, followed by a life-long process of clinical support. However, even with rehabilitation therapy, 50% to 95% of stroke survivors remain impaired. There is thus a great need for new therapeutic developments for patients with disability after stroke, which is largely unexplored. Regenerative cell-based therapies offer long-term hope for many patients with stroke, as stem cells might be possible for dead or injured neural cells to be replaced after acute stroke. 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 stroke. The neurological outcome will be determined after transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 40-70 ischemia stroke or intracerebral hemorrhage patient\n* With stroke history of more than 3 months, less than 60 months\n* With stable hemiplegia condition\n* NIHSS (NIH stroke scale) score of 7 or more points\n* Patient is stable (normal respiration, afebrile, BP less than mean arterial pressure of 125 mm of Hg, fasting blood sugar \\<7 mg, and normal urea/electrolytes for at least 48 hours.)\n\nExclusion Criteria:\n\n* Patients aged less than 40 or more than 70\n* Lacunar infarction\n* History of neurological disease, head injury or psychiatric disorder with disablity\n* Pregnant women\n* Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition\n* Inaccessibility for follow up\n* Unwillingness to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT01714167', 'briefTitle': 'Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Chronic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Wenzhou Medical University'}, 'officialTitle': 'Autologous Bone Marrow Mesenchymal Stem Cell Transplantation for Treatment of Chronic Stroke', 'orgStudyIdInfo': {'id': 'WZMC-2011-8'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'intracerebral stem cell transplantation', 'description': 'Intracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient plus conventional treatment include rehabilitation', 'interventionNames': ['Genetic: intracerebral stem cell transplantation']}, {'type': 'NO_INTERVENTION', 'label': 'conventional treatment', 'description': 'Control group receive conventional stroke treatment that include rehabilitation'}], 'interventions': [{'name': 'intracerebral stem cell transplantation', 'type': 'GENETIC', 'description': 'Intracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient', 'armGroupLabels': ['intracerebral stem cell transplantation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32500', 'city': 'Wenzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'facility': 'The First Affiliated Hospital of Wenzhou Medical College', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}], 'centralContacts': [{'name': 'Qichuan Zhuge, M.D.', 'role': 'CONTACT', 'email': 'zhugeqichuan@vip.163.com'}], 'overallOfficials': [{'name': 'Kunlin Jin, M.D., Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of North Texas Health Science Center'}, {'name': 'Qichuan Zhuge, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'First Affiliated Hospital of Wenzhou Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wenzhou Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of North Texas Health Science Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Neurosurgery', 'investigatorFullName': 'Qichuan Zhuge', 'investigatorAffiliation': 'Wenzhou Medical University'}}}}