Ignite Creation Date:
2025-12-24 @ 5:04 PM
Ignite Modification Date:
2026-02-23 @ 8:06 PM
Study NCT ID:
NCT01845350
Status:
COMPLETED
Last Update Posted:
2016-11-04
First Post:
2013-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Autologous M2 Macrophage in Treatment of Non-Acute Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}, {'id': 'D000083302', 'term': 'Hemorrhagic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-03', 'studyFirstSubmitDate': '2013-04-24', 'studyFirstSubmitQcDate': '2013-04-29', 'lastUpdatePostDateStruct': {'date': '2016-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of patients with recurrent vascular episodes', 'timeFrame': '1-3 days, 6 months'}], 'primaryOutcomes': [{'measure': 'The number of patients with severe adverse events', 'timeFrame': '1-3 days, 6 months', 'description': 'Occurence of severe adverse events including mortality, neurological worsening and seizures'}], 'secondaryOutcomes': [{'measure': 'Improvement of functional outcome in National Institutes of Health Stroke Scale (NIHSS)', 'timeFrame': '1-3 days, 6 months'}, {'measure': 'Improvement in Barthel Index', 'timeFrame': '1-3 days, 6 months'}, {'measure': 'Improvement in modified Rankin scale', 'timeFrame': '1-3 days, 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ischemic Stroke', 'Hemorrhagic Stroke']}, 'referencesModule': {'references': [{'pmid': '26671426', 'type': 'RESULT', 'citation': 'Chernykh ER, Shevela EY, Starostina NM, Morozov SA, Davydova MN, Menyaeva EV, Ostanin AA. Safety and Therapeutic Potential of M2 Macrophages in Stroke Treatment. Cell Transplant. 2016;25(8):1461-71. doi: 10.3727/096368915X690279. Epub 2015 Dec 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether M2 macrophages are safe and feasible in the treatment of non-acute stroke patients', 'detailedDescription': 'Our primary hypothesis is that autologous M2 macrophage transplantation via intrathecal introduction is feasible and safe after non-acute stroke. Our secondary hypothesis is that autologous M2 macrophage transplantation is associated with improved neurological outcome after non-acute stroke'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Computed tomography confirmed ischemic or hemorrhagic stroke\n* Duration since stroke onset more than 3 and less than 12 months\n* Age between 18 and 75 years old\n* Persistent neurological deficits more than 4 points in NIHSS stroke scale\n* Signed informed consent\n\nExclusion Criteria:\n\n* The history of previous stroke\n* Seizures\n* Thrombophilias or primary hematological diseases\n* Malignancy\n* Hepatic or renal dysfunctions\n* Hemodynamic or respiratory instability\n* Autoimmune disease\n* HIV or uncontrolled bacterial, fungal, or viral infections\n* Pregnancy\n* Participation in other clinical trials'}, 'identificationModule': {'nctId': 'NCT01845350', 'briefTitle': 'Safety of Autologous M2 Macrophage in Treatment of Non-Acute Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'Siberian Branch of the Russian Academy of Medical Sciences'}, 'officialTitle': 'Safety and Feasibility of Autologous M2 Macrophage Transplantation in Treatment of Non-Acute Stroke Patients', 'orgStudyIdInfo': {'id': 'STR-M2-2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'M2 macrophages', 'description': 'M2 macrophage introduction', 'interventionNames': ['Other: M2 macrophage introduction']}], 'interventions': [{'name': 'M2 macrophage introduction', 'type': 'OTHER', 'description': '* Generation of autologous M2 macrophages from peripheral blood of non-acute stroke patients\n* Intrathecal introduction of autologous M2 macrophages', 'armGroupLabels': ['M2 macrophages']}]}, 'contactsLocationsModule': {'locations': [{'zip': '630099', 'city': 'Novosibirsk', 'country': 'Russia', 'facility': 'Research Institute of Clinical Immunology, Russian Academy of Medical Sciences (Siberian Branch)', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}], 'overallOfficials': [{'name': 'Elena R. Chernykh, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Research Institute of Clinical Immunology, Russian Academy of Medical Sciences (Siberian Branch)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Siberian Branch of the Russian Academy of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Researcher, Laboratory of Cellular Therapy, Research Institute of Clinical Immunology', 'investigatorFullName': 'Ekaterina Y. Shevela', 'investigatorAffiliation': 'Siberian Branch of the Russian Academy of Medical Sciences'}}}}