Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-31 @ 7:47 PM
Study NCT ID:
NCT01028794
Status:
COMPLETED
Last Update Posted:
2013-07-08
First Post:
2009-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Bone Marrow Mononuclear Cell Transplantation for Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020766', 'term': 'Intracranial Embolism'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002542', 'term': 'Intracranial Embolism and Thrombosis'}, {'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': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-04', 'studyFirstSubmitDate': '2009-12-08', 'studyFirstSubmitQcDate': '2009-12-08', 'lastUpdatePostDateStruct': {'date': '2013-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement of NIHSS（National Institute of Health Stroke Scale）', 'timeFrame': '30 days after treatment'}, {'measure': 'Frequency of change for the worse in NIHSS', 'timeFrame': '30 days aftrer treatment'}], 'secondaryOutcomes': [{'measure': 'Mean level of mRS (modified Rankin Scale)', 'timeFrame': '30 days after treatment'}, {'measure': 'Frequency of death', 'timeFrame': 'day 30 after treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['stroke', 'bone marrow', 'mononuclear cell', 'angiogenesis', 'neurogenesis'], 'conditions': ['Cerebral Embolism', 'Stroke']}, 'referencesModule': {'references': [{'pmid': '15286799', 'type': 'BACKGROUND', 'citation': 'Taguchi A, Soma T, Tanaka H, Kanda T, Nishimura H, Yoshikawa H, Tsukamoto Y, Iso H, Fujimori Y, Stern DM, Naritomi H, Matsuyama T. Administration of CD34+ cells after stroke enhances neurogenesis via angiogenesis in a mouse model. J Clin Invest. 2004 Aug;114(3):330-8. doi: 10.1172/JCI20622.'}, {'pmid': '12623341', 'type': 'BACKGROUND', 'citation': 'Taguchi A, Ohtani M, Soma T, Watanabe M, Kinosita N. Therapeutic angiogenesis by autologous bone-marrow transplantation in a general hospital setting. Eur J Vasc Endovasc Surg. 2003 Mar;25(3):276-8. doi: 10.1053/ejvs.2002.1831. No abstract available.'}, {'pmid': '15184275', 'type': 'BACKGROUND', 'citation': 'Taguchi A, Matsuyama T, Moriwaki H, Hayashi T, Hayashida K, Nagatsuka K, Todo K, Mori K, Stern DM, Soma T, Naritomi H. Circulating CD34-positive cells provide an index of cerebrovascular function. Circulation. 2004 Jun 22;109(24):2972-5. doi: 10.1161/01.CIR.0000133311.25587.DE. Epub 2004 Jun 7.'}, {'pmid': '17614944', 'type': 'BACKGROUND', 'citation': 'Taguchi A, Wen Z, Myojin K, Yoshihara T, Nakagomi T, Nakayama D, Tanaka H, Soma T, Stern DM, Naritomi H, Matsuyama T. Granulocyte colony-stimulating factor has a negative effect on stroke outcome in a murine model. Eur J Neurosci. 2007 Jul;26(1):126-33. doi: 10.1111/j.1460-9568.2007.05640.x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether autologous bone marrow mononuclear cells transplantation after stroke is safe and/or effective to improve neurological outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with cerebral embolism.\n* NIHSS score is more than (or equal to) 10.\n* On day 7 after onset of stroke, the improvement of NIHSS is less than (or equal to) 5, compared with the level at administration.\n* Bone marrow aspiration can be done in 10 days after onset of stroke\n\nExclusion Criteria:\n\n* Patient with cerebral hemorrhage or symptomatic hemorrhagic infarction.\n* Patient who expects brain surgery.\n* Patient with acute myocardial infarction.\n* Patient with coagulation disorder.\n* Number of Platelet \\< 100000/mm3\n* Serum creatinine level \\>2.0mg/dl\n* Patient with malignancy.\n* Patient with uncontrolled proliferative diabetic retinopathy.\n* Patient suspected infective endocarditis.\n* HBV, HCV, HIV or HTLV positive'}, 'identificationModule': {'nctId': 'NCT01028794', 'briefTitle': 'Autologous Bone Marrow Mononuclear Cell Transplantation for Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'National Cerebral and Cardiovascular Center, Japan'}, 'officialTitle': 'Phase 1/2A Study of Intravenous Autologous Bone Marrow Mononuclear Cell Transplantation for Patients After Cerebral Embolism', 'orgStudyIdInfo': {'id': 'UMIN000001133'}, 'secondaryIdInfos': [{'id': 'UMIN000001133', 'type': 'OTHER', 'domain': 'University hospital Medical Information Network in Japan'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'autologous bone marrow mononuclear cell', 'description': 'On day 7-10 after stroke, patient has 25ml of bone marrow cells aspiration. Mononuclear cells are purified by Ficoll and administrated intravenously.', 'interventionNames': ['Biological: autologous bone marrow mononuclear cells']}, {'type': 'EXPERIMENTAL', 'label': 'autologous bone marrow mononuclear cells', 'description': 'On day 7-10 after stroke, patient has 50ml of bone marrow cells aspiration. Mononuclear cells are purified by Ficoll and administrated intravenously.', 'interventionNames': ['Biological: autologous bone marrow mononuclear cells']}], 'interventions': [{'name': 'autologous bone marrow mononuclear cells', 'type': 'BIOLOGICAL', 'description': 'intravenous administration of autologous bone marrow derived mononuclear cells obtained from 25ml of bone marrow on day 7-10 after stroke (only once in that period)', 'armGroupLabels': ['autologous bone marrow mononuclear cell']}, {'name': 'autologous bone marrow mononuclear cells', 'type': 'BIOLOGICAL', 'description': 'intravenous administration of autologous bone marrow derived mononuclear cells obtained from 50ml of bone marrow on day 7-10 after stroke (only once in that period)', 'armGroupLabels': ['autologous bone marrow mononuclear cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '565-8565', 'city': 'Suita', 'state': 'Osaka', 'country': 'Japan', 'facility': 'Department of Cerebrovascular Disease, National Cardiovascular Center', 'geoPoint': {'lat': 34.76143, 'lon': 135.51567}}], 'overallOfficials': [{'name': 'Akihiko Taguchi, MD.PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Cerebrovascular Disease, National Cardiovascular Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cerebral and Cardiovascular Center, Japan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'guest investigator', 'investigatorFullName': 'Akihiko Taguchi', 'investigatorAffiliation': 'National Cerebral and Cardiovascular Center, Japan'}}}}