{ "FullStudy":{ "Rank":217680, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01518231", "OrgStudyIdInfo":{ "OrgStudyId":"Zhejiang Hospital" }, "Organization":{ "OrgFullName":"Zhejiang Hospital", "OrgClass":"OTHER" }, "BriefTitle":"Autologous Hematopoietic Stem Cell Transplantation in Ischemic Stroke", "OfficialTitle":"Phase 1 Study of Autologous Peripheral Hematopoietic Stem Cell Transplantation in Ischemic Stroke", "Acronym":"AHSCTIS" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Unknown status", "LastKnownStatus":"Recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"December 2012", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"December 2013", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 10, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 24, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 25, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Yaguo Li", "ResponsiblePartyInvestigatorTitle":"Yaguo Li", "ResponsiblePartyInvestigatorAffiliation":"Zhejiang Hospital" }, "LeadSponsor":{ "LeadSponsorName":"Zhejiang Hospital", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"Zhejiang University", "CollaboratorClass":"OTHER" } ] } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to evaluate the safety and efficacy of autologous peripheral hematopoietic stem cell transplantation in ischemic stroke.", "DetailedDescription":"Stroke is among the main causes of mortality and disability of elderly population which still lack of efficient therapy. Stem sell transplantation provides a functional improvement after cerebral ischemia in rat models. Our study will recruit 40 ischemic stroke patients which will be divided into 2 groups (20 patients each): treatment group and control group. The former will be implanted with peripheral blood stem cell through anterior cerebral artery or middle cerebral artery (determined by the section of infarction) and receive convention stroke therapy. The latter only receive convention stroke therapy. The investigators expect that transplantation of the peripheral hematopoietic stem cell is safe and efficient to neurological recovery." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Stroke" ] }, "KeywordList":{ "Keyword":[ "stroke", "hematopoietic stem cell transplantation" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"40", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"cell transplantation", "ArmGroupType":"Experimental", "ArmGroupDescription":"The study group will not only be implanted with autologous hematopoietic stem cells, but also receive drug therapy.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Procedure: autologous hematopoiesis stem cell transplantation", "Drug: Aspirin", "Drug: Warfarin", "Drug: Atorvastatin", "Drug: Edaravone" ] } },{ "ArmGroupLabel":"Convention therapy", "ArmGroupType":"No Intervention", "ArmGroupDescription":"The control group just receive drug therapy.", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Aspirin", "Drug: Warfarin", "Drug: Atorvastatin", "Drug: Edaravone" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Procedure", "InterventionName":"autologous hematopoiesis stem cell transplantation", "InterventionDescription":"Every participant will be transplanted with about 4 million autologous peripheral blood stem cell(CD34+) through cerebral artery.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "cell transplantation" ] } },{ "InterventionType":"Drug", "InterventionName":"Aspirin", "InterventionDescription":"aspirin 100mg,qd,po(patients with no fibrillation atrial)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "cell transplantation" ] } },{ "InterventionType":"Drug", "InterventionName":"Warfarin", "InterventionDescription":"warfarin 2~6mg,qd,po(patients with fibrillation atrial);", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "cell transplantation" ] } },{ "InterventionType":"Drug", "InterventionName":"Atorvastatin", "InterventionDescription":"atorvastatin 20mg,qd,po", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "cell transplantation" ] } },{ "InterventionType":"Drug", "InterventionName":"Edaravone", "InterventionDescription":"edaravone 30mg,bid,ivgtt.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "cell transplantation" ] } },{ "InterventionType":"Drug", "InterventionName":"Aspirin", "InterventionDescription":"aspirin 100mg,qd,po(patients with no fibrillation atrial)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Convention therapy" ] } },{ "InterventionType":"Drug", "InterventionName":"Warfarin", "InterventionDescription":"warfarin 2~6mg,qd,po(patients with fibrillation atrial)", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Convention therapy" ] } },{ "InterventionType":"Drug", "InterventionName":"Atorvastatin", "InterventionDescription":"atorvastatin 20mg,qd,po", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Convention therapy" ] } },{ "InterventionType":"Drug", "InterventionName":"Edaravone", "InterventionDescription":"edaravone 30mg,bid,ivgtt", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Convention therapy" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change from Baseline in NIH-stroke scale (NIHSS) at 12 months", "PrimaryOutcomeTimeFrame":"1,3,6,12 months after cell transplantation" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Barthel index", "SecondaryOutcomeTimeFrame":"1,3,6,12 months after cell transplantation" },{ "SecondaryOutcomeMeasure":"perfusion magnetic resonance imaging scan", "SecondaryOutcomeTimeFrame":"1,3,6,12 months after cell transplantation" },{ "SecondaryOutcomeMeasure":"Modified Rankin Scale(mRS)", "SecondaryOutcomeTimeFrame":"3,6,12 months after cell transplantation" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\naged 40~70\nno consciousness disorders\ninternal carotid artery territory infarction\nstroke happened < 1 year\nwith stable hemiplegia, but remain dependent in daily life\nSSS(Scandinavian Stroke Scale) < 40\n\nExclusion Criteria:\n\npregnant women\ncan't tolerate the test because of other disease, such as heart failure, liver failure, renal failure, abnormal blood coagulation, AIDS, combine other tumor or special condition", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"40 Years", "MaximumAge":"70 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "CentralContactList":{ "CentralContact":[ { "CentralContactName":"Yaguo Li, master", "CentralContactRole":"Contact", "CentralContactPhone":"0086-0571-87987373", "CentralContactPhoneExt":"5103", "CentralContactEMail":"tjqlyg@163.com" },{ "CentralContactName":"Yumiao Zhou, master", "CentralContactRole":"Contact", "CentralContactPhone":"0086-0571-87987373", "CentralContactPhoneExt":"5094", "CentralContactEMail":"zlf859@yahoo.com.cn" } ] }, "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Yaguo Li, master", "OverallOfficialAffiliation":"Zhejiang Hospital", "OverallOfficialRole":"Study Director" },{ "OverallOfficialName":"Yumiao Zhou, master", "OverallOfficialAffiliation":"Zhejiang Hospital", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Yaguo Li", "LocationStatus":"Recruiting", "LocationCity":"Hangzhou", "LocationState":"Zhejiang", "LocationZip":"310013", "LocationCountry":"China", "LocationContactList":{ "LocationContact":[ { "LocationContactName":"Yumiao Zhou, master", "LocationContactRole":"Contact", "LocationContactPhone":"0086-0571-87987373", "LocationContactPhoneExt":"5094", "LocationContactEMail":"zlf859@yahoo.com.cn" } ] } } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000001241", "InterventionMeshTerm":"Aspirin" },{ "InterventionMeshId":"D000077553", "InterventionMeshTerm":"Edaravone" },{ "InterventionMeshId":"D000014859", "InterventionMeshTerm":"Warfarin" },{ "InterventionMeshId":"D000069059", "InterventionMeshTerm":"Atorvastatin" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000894", "InterventionAncestorTerm":"Anti-Inflammatory Agents, Non-Steroidal" },{ "InterventionAncestorId":"D000018712", "InterventionAncestorTerm":"Analgesics, Non-Narcotic" },{ "InterventionAncestorId":"D000000700", 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"InterventionAncestorTerm":"Cyclooxygenase Inhibitors" },{ "InterventionAncestorId":"D000004791", "InterventionAncestorTerm":"Enzyme Inhibitors" },{ "InterventionAncestorId":"D000058633", "InterventionAncestorTerm":"Antipyretics" },{ "InterventionAncestorId":"D000000924", "InterventionAncestorTerm":"Anticholesteremic Agents" },{ "InterventionAncestorId":"D000000960", "InterventionAncestorTerm":"Hypolipidemic Agents" },{ "InterventionAncestorId":"D000000963", "InterventionAncestorTerm":"Antimetabolites" },{ "InterventionAncestorId":"D000057847", "InterventionAncestorTerm":"Lipid Regulating Agents" },{ "InterventionAncestorId":"D000019161", "InterventionAncestorTerm":"Hydroxymethylglutaryl-CoA Reductase Inhibitors" },{ "InterventionAncestorId":"D000000925", "InterventionAncestorTerm":"Anticoagulants" },{ "InterventionAncestorId":"D000016166", "InterventionAncestorTerm":"Free Radical Scavengers" },{ "InterventionAncestorId":"D000000975", "InterventionAncestorTerm":"Antioxidants" },{ "InterventionAncestorId":"D000018696", "InterventionAncestorTerm":"Neuroprotective Agents" },{ "InterventionAncestorId":"D000020011", "InterventionAncestorTerm":"Protective Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M3129", "InterventionBrowseLeafName":"Aspirin", "InterventionBrowseLeafAsFound":"Aspirin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M351", "InterventionBrowseLeafName":"Atorvastatin", "InterventionBrowseLeafAsFound":"Atorvastatin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M16185", "InterventionBrowseLeafName":"Warfarin", "InterventionBrowseLeafAsFound":"Warfarin", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M1831", "InterventionBrowseLeafName":"Edaravone", "InterventionBrowseLeafAsFound":"Edaravone", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2799", "InterventionBrowseLeafName":"Anti-Inflammatory Agents, Non-Steroidal", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2798", "InterventionBrowseLeafName":"Anti-Inflammatory Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2613", "InterventionBrowseLeafName":"Analgesics", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19370", "InterventionBrowseLeafName":"Analgesics, Non-Narcotic", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19188", "InterventionBrowseLeafName":"Antirheumatic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M7056", "InterventionBrowseLeafName":"Fibrinolytic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M12448", "InterventionBrowseLeafName":"Platelet Aggregation Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M17792", "InterventionBrowseLeafName":"Cyclooxygenase Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M27763", "InterventionBrowseLeafName":"Antipyretics", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2824", "InterventionBrowseLeafName":"Anticholesteremic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2859", "InterventionBrowseLeafName":"Hypolipidemic Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2862", "InterventionBrowseLeafName":"Antimetabolites", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M27470", "InterventionBrowseLeafName":"Lipid Regulating Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19739", "InterventionBrowseLeafName":"Hydroxymethylglutaryl-CoA Reductase Inhibitors", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2825", "InterventionBrowseLeafName":"Anticoagulants", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2873", "InterventionBrowseLeafName":"Antioxidants", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M19357", "InterventionBrowseLeafName":"Neuroprotective Agents", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M20453", "InterventionBrowseLeafName":"Protective Agents", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Antipy", "InterventionBrowseBranchName":"Antipyretics" },{ "InterventionBrowseBranchAbbrev":"Infl", "InterventionBrowseBranchName":"Anti-Inflammatory Agents" },{ "InterventionBrowseBranchAbbrev":"ARhu", "InterventionBrowseBranchName":"Antirheumatic Agents" },{ "InterventionBrowseBranchAbbrev":"FiAg", "InterventionBrowseBranchName":"Fibrinolytic Agents" },{ "InterventionBrowseBranchAbbrev":"Analg", "InterventionBrowseBranchName":"Analgesics" },{ "InterventionBrowseBranchAbbrev":"PlAggInh", "InterventionBrowseBranchName":"Platelet Aggregation Inhibitors" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" },{ "InterventionBrowseBranchAbbrev":"Lipd", "InterventionBrowseBranchName":"Lipid Regulating Agents" },{ "InterventionBrowseBranchAbbrev":"AnCoag", "InterventionBrowseBranchName":"Anticoagulants" },{ "InterventionBrowseBranchAbbrev":"NeuroAg", "InterventionBrowseBranchName":"Neuroprotective Agents" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000020521", "ConditionMeshTerm":"Stroke" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000002561", "ConditionAncestorTerm":"Cerebrovascular Disorders" },{ "ConditionAncestorId":"D000001927", "ConditionAncestorTerm":"Brain Diseases" },{ "ConditionAncestorId":"D000002493", "ConditionAncestorTerm":"Central Nervous System Diseases" },{ "ConditionAncestorId":"D000009422", "ConditionAncestorTerm":"Nervous System Diseases" },{ "ConditionAncestorId":"D000014652", "ConditionAncestorTerm":"Vascular Diseases" },{ "ConditionAncestorId":"D000002318", "ConditionAncestorTerm":"Cardiovascular Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M20890", "ConditionBrowseLeafName":"Stroke", "ConditionBrowseLeafAsFound":"Stroke", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9126", "ConditionBrowseLeafName":"Ischemia", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4393", "ConditionBrowseLeafName":"Cerebrovascular Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3786", "ConditionBrowseLeafName":"Brain Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4325", "ConditionBrowseLeafName":"Central Nervous System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M15983", "ConditionBrowseLeafName":"Vascular Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC10", "ConditionBrowseBranchName":"Nervous System Diseases" },{ "ConditionBrowseBranchAbbrev":"BC14", "ConditionBrowseBranchName":"Heart and Blood Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" } ] } } } } } }