Ignite Creation Date:
2025-12-24 @ 6:54 PM
Ignite Modification Date:
2026-02-23 @ 2:21 AM
Study NCT ID:
NCT00473057
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2007-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Autologous Stem Cell Transplantation for Patients With Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020244', 'term': 'Infarction, Middle Cerebral Artery'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002544', 'term': 'Cerebral Infarction'}, {'id': 'D020520', 'term': 'Brain Infarction'}, {'id': 'D002545', 'term': 'Brain Ischemia'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002539', 'term': 'Cerebral Arterial Diseases'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-05-18', 'studyFirstSubmitDate': '2007-05-10', 'studyFirstSubmitQcDate': '2007-05-10', 'lastUpdatePostDateStruct': {'date': '2011-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Absence of new neurological deficits during the procedure and/or in the 4 months follow-up.', 'timeFrame': '4 months'}], 'secondaryOutcomes': [{'measure': 'Improvement of neurological deficits', 'timeFrame': '4 months'}, {'measure': 'Improvement in the neuroimaging exams', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute stroke', 'middle cerebral artery', 'autologous transplantation', 'bone marrow cells', 'stem cells', 'cell therapy'], 'conditions': ['Infarction, Middle Cerebral Artery']}, 'descriptionModule': {'briefSummary': 'This is a open label study to assess the safety of autologous bone marrow transplantation in patients with a ischemic stroke in the middle cerebral artery territory within 90 days from symptoms onset.', 'detailedDescription': 'Objective: The purpose of this study is to evaluate the safety and feasibility of intra-arterial and intravenous injection of autologous bone marrow mononuclear cells in patients in the acute and sub-acute phase (\\> 3 and \\< 90 days after symptoms onset) of ischemic cerebral infarct in the middle cerebral artery territory.\n\nMethods: 15 patients with cerebral infarct within the middle cerebral artery territory will be enrolled in this prospective, nonrandomized, open-labeled study. Up to 10 patients will receive up to 500x 10 6 autologous bone marrow cells injected intra-arterially into the middle cerebral artery through percutaneous approach. The procedure is monitored by Transcranial Doppler (TCD) and electroencephalogram (EEG). Other 5 patients will receive up to 500x 10 6 autologous bone marrow cells injected intravenously. Changes in neurological deficits and improvements in functions will be evaluated at baseline and at regular intervals during follow-up ( 4 months). EEG and neuroimaging exams will be performed at baseline and at regular intervals during the follow-up period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* clinical diagnosis of ischemic stroke lasting for more than 3 hours and less than 90 days from symptoms onset\n* neuroimages exams showing ischemic cerebral infarct in the middle cerebral artery territory\n* age between 18 and 75 years old\n* NIHSS between 4 and 20\n* spontaneous re-canalization of the middle cerebral artery documented by TCD or MRI\n* signed informed consent\n\nExclusion Criteria:\n\n* difficult in obtaining vascular access for percutaneous procedures\n* vascular impossibility to reach the middle cerebral artery through percutaneous approach\n* severe carotid stenosis( \\>70%, by Doppler) related to the severe stroke\n* neurological worsening (\\>4 points in the NIHSS ) due to edema or intracerebral hemorrhage\n* primary hematological disease\n* neurodegenerative disorder\n* previous stroke with mRS \\> 2\n* intracardiac thrombosis\n* auto-imune disorders\n* osteopathies that could increase the risk of bone marrow harvesting procedure\n* thrombophilias\n* liver failure\n* chronic renal failure (creatinine \\> 2mg/ml)\n* life support dependence\n* lacunar stroke\n* pregnancy\n* history of neoplasia or other comorbidity that could impact patient's short-term survival\n* any condition that in the judgment of the investigator would place the patient under undue risk"}, 'identificationModule': {'nctId': 'NCT00473057', 'briefTitle': 'Study of Autologous Stem Cell Transplantation for Patients With Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Universidade Federal do Rio de Janeiro'}, 'officialTitle': 'Phase I Study of Autologous Bone Marrow Cell Transplantation in Patient With Ischemic Stroke', 'orgStudyIdInfo': {'id': 'CONEP-10385'}, 'secondaryIdInfos': [{'id': 'CEP-HUCFF/UFRJ-169/03'}, {'id': 'Proc.-CNPq-55.2201/2005-7'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Autologous cell transplantation', 'type': 'OTHER', 'description': 'Intra-arterial or intravenous delivery of autologous bone marrow cells'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21.941-590', 'city': 'Rio de Janeiro', 'state': 'Rio de Janeiro', 'country': 'Brazil', 'facility': 'Hospital Universitário Clementino Fraga Filho/UFRJ', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}], 'overallOfficials': [{'name': 'Charles André, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Federal do Rio de Janeiro'}, {'name': 'Gabriel R de Freitas, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Federal do Rio de Janeiro'}, {'name': 'Rosalia Mendez-Otero, Md, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Federal do Rio de Janeiro'}, {'name': 'Lea Mirian Barbosa da Fonseca, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade Federal do Rio de Janeiro'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade Federal do Rio de Janeiro', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Science and Technology, Brazil', 'class': 'OTHER'}, {'name': 'Ministry of Health, Brazil', 'class': 'OTHER_GOV'}, {'name': 'National Research Council, Brazil', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Charles Andre, MD, PhD', 'oldOrganization': 'Universidade Federal do Rio de Janeiro'}}}}