Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2025-12-26 @ 3:20 AM
Study NCT ID:
NCT01461720
Status:
UNKNOWN
Last Update Posted:
2015-04-01
First Post:
2011-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intravenous Autologous Mesenchymal Stem Cells Transplantation to Treat Middle Cerebral Artery Infarct
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020244', 'term': 'Infarction, Middle Cerebral Artery'}], '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': 'D020521', 'term': 'Stroke'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-30', 'studyFirstSubmitDate': '2011-10-25', 'studyFirstSubmitQcDate': '2011-10-26', 'lastUpdatePostDateStruct': {'date': '2015-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in NIH Stroke Scale', 'timeFrame': '1 year'}, {'measure': 'Change in Barthel Index', 'timeFrame': '1 year'}, {'measure': 'Change in modified Rankin Scale', 'timeFrame': '1 year'}, {'measure': 'Change in size of infarct based on brain MRI stroke sequences', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Change in Stroke Specific Quality of Life Scale', 'timeFrame': '1 year'}, {'measure': 'Change in Stroke Impact Scale', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bone marrow', 'Autologous', 'Mesenchymal stem cells', 'Unilateral middle cerebral artery infarct'], 'conditions': ['Middle Cerebral Artery Infarction']}, 'descriptionModule': {'briefSummary': 'This study aims to determine the efficacy of intravenous transplantation of autologous bone marrow-derived mesenchymal stem cells in patients with acute middle cerebral artery infarct.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Experiences stroke onset within 2 weeks to 2 months\n* NIHSS score of \\>10-35\n* Never received or failed thrombolysis\n* Evidence of unilateral middle cerebral artery infarct on brain MRI\n\nExclusion Criteria:\n\n* Medically unfit (eg. those are unstable haemodynamically despite treatment, with worsening conscious level and with other serious medical co-morbidity)\n* Evidence of any tumor or other space-occupying lesion on brain MRI\n* Evidence of hemorrhagic stroke on brain CT or MRI\n* Experiences transient ischemic attack or lacunar infarct\n* Has any acute or chronic infections such as Hepatitis B, Hepatitis C and HIV\n* Is diagnosed with concurrent malignancy or primary hematological disorders\n* Renal impairment indicated with serum creatinine greater than 200 umol/l or creatinine clearance less than 30 ml/min\n* Liver impairment indicated with serum aspartate transaminase and serum alanine transaminase greater than 4 times upper limit of the normal range\n* Any contraindication to stem cell transplantation or bone marrow biopsy\n* Any co-morbidity which will compromise the ability to obtain adequate stem cells (eg. chronic debilitating diseases, frail patients and patients with known osteoporosis)\n* Any contraindication to brain MRI (eg. metal implants, pacemaker, joint implants and ocular implants)'}, 'identificationModule': {'nctId': 'NCT01461720', 'briefTitle': 'Intravenous Autologous Mesenchymal Stem Cells Transplantation to Treat Middle Cerebral Artery Infarct', 'organization': {'class': 'OTHER', 'fullName': 'National University of Malaysia'}, 'officialTitle': 'An Open Lable, Phase II Exploratory Study Assessing the Efficacy of Intravenous Autologous Mesenchymal Stem Cells in Patients With Middle Cerebral Artery Infarct', 'orgStudyIdInfo': {'id': 'FF-115-2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard medical care', 'description': 'This is the control arm, which is given the best evidence-based standard treatment for the management of acute stroke', 'interventionNames': ['Other: Standard medical care']}, {'type': 'EXPERIMENTAL', 'label': 'BM-MSCs', 'description': 'Autologous bone marrow-derived mesenchymal stem cells(BM-MSCs)', 'interventionNames': ['Other: Standard medical care', 'Biological: Autologous bone marrow-derived mesenchymal stem cells']}], 'interventions': [{'name': 'Standard medical care', 'type': 'OTHER', 'description': 'Standard medical care includes treatment to prevent recurrence, optimal control of risk factors and post stroke follow-up rehabilitative treatment.', 'armGroupLabels': ['BM-MSCs', 'Standard medical care']}, {'name': 'Autologous bone marrow-derived mesenchymal stem cells', 'type': 'BIOLOGICAL', 'description': 'Single intravenous infusion of autologous bone marrow-derived mesenchymal stem cells concurrently with standard medical care.', 'armGroupLabels': ['BM-MSCs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56000', 'city': 'Kuala Lumpur', 'status': 'RECRUITING', 'country': 'Malaysia', 'contacts': [{'name': 'Norlinah Mohamed Ibrahim, MD', 'role': 'CONTACT'}, {'name': 'Norlinah Mohamed Ibrahim, MBBCH,MRCP,BAO', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hui-Jan Tan, MRCP, MMed', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UKM Medical Centre', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}], 'centralContacts': [{'name': 'Norlinah Mohamed Ibrahim, MD', 'role': 'CONTACT', 'email': 'norlinah@ppukm.ukm.edu.my, norlinah@gmail.com'}], 'overallOfficials': [{'name': 'Norlinah Mohamed Ibrahim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UKM Medical Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University of Malaysia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cytopeutics Sdn. Bhd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant Neurologist', 'investigatorFullName': 'Dr Norlinah Mohamed Ibrahim', 'investigatorAffiliation': 'National University of Malaysia'}}}}