{ "FullStudy":{ "Rank":217688, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01518127", "OrgStudyIdInfo":{ "OrgStudyId":"Sao Paulo University" }, "Organization":{ "OrgFullName":"University of Sao Paulo", "OrgClass":"OTHER" }, "BriefTitle":"Intravitreal Bone Marrow-Derived Stem Cells in Patients With Macular Degeneration", "OfficialTitle":"Intravitreal Bone Marrow-Derived Stem Cells in Patients With Macular Degeneration", "Acronym":"AMDCELL" }, "StatusModule":{ "StatusVerifiedDate":"July 2017", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"August 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"September 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"December 2015", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"September 20, 2011", "StudyFirstSubmitQCDate":"January 22, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"July 18, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"July 21, 2017", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Rubens Camargo Siqueira", "ResponsiblePartyInvestigatorTitle":"MD,PhD - Principal Investigator", "ResponsiblePartyInvestigatorAffiliation":"University of Sao Paulo" }, "LeadSponsor":{ "LeadSponsorName":"University of Sao Paulo", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to evaluate the behavior of intravitreal injection of of autologous bone marrow stem cells in patients with age related macular degeneration.", "DetailedDescription":"A prospective phase I/II, nonrandomized open-label study of agen related macular degeneration and Stargartd patients with best-corrected ETDRS visual acuity (BCVA) worse than 20/200. Standardized ophthalmic evaluation will be perform at baseline and at weeks 1, 4,12 and 24 (±1) following intravitreal injection of 10 x 106 bone marrow stem cells/ 0,1ml . Three measures will be used to evaluate the short-term safety of intravitreal of bone marrow stem cells: 1) severe visual loss, defined as a drop in 15 letters on ETDRS visual acuity scale; 2) decrease in ERG response; 3) decrease in 5 square degrees on visual field; secondary safety outcomes : 1) increase in intra-ocular inflammation defined herein as anterior chamber cells and flare higher than 3+ for more than 1 month after injection according to a classification described elsewhere ; 2) decrease in CMT more than 50um; 3)genesis of abnormal tissues (teratomas) or tumors; 4) qualitative changes in retinal or choroidal perfusion, like macular nonperfusion. Secondary outcome measures will be used to evaluate the short-term efficiency of intravitreal of Bone Marrow Stem Cells: 1) improvement in ERG response; 2) increase in visual field: 3) increase in CSMT > 50um and not related to macular edemar or choroidal neovascularization; 4) increase > 5 letters on BCVA" }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Age Related Macular Degeneration and Stargartd" ] }, "KeywordList":{ "Keyword":[ "Macular Degeneration" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Not Applicable" ] }, "DesignInfo":{ "DesignInterventionModel":"Single Group Assignment", "DesignInterventionModelDescription":"intravitreal injection of autologous bone marrow stem cells", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"None (Open Label)" } }, "EnrollmentInfo":{ "EnrollmentCount":"20", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"stem cell group", "ArmGroupType":"Experimental", "ArmGroupDescription":"intravitreal injection of autologous bone marrow stem cells", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Other: intravitreal injection of autologous bone marrow stem cells" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Other", "InterventionName":"intravitreal injection of autologous bone marrow stem cells", "InterventionDescription":"intravitreal injection of autologous bone marrow stem cells", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "stem cell group" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Cell Therapy" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"ETDRS Visual acuity change", "PrimaryOutcomeDescription":"Primary safety outcome included visual acuity loss of 15 or more ETDRS letters after treatment", "PrimaryOutcomeTimeFrame":"Day 1 to Day 365" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nMale or female AMD and Stargartd patients 18 to 80 years old, inclusive.\nIn either eye, diagnosis of geographic atrophy or choroidal neovascularization due to AMD\nETDRS best corrected visual acuity of 60 letters or worse in the study eye.\n\nExclusion Criteria:\n\nRetinal disease other than AMD in study eye which, in the investigator's opinion, may pose a safety risk or interfere with the study.\nChoroidal neovascularization due to a cause other than AMD.\nIn the study eye, media opacity that interferes with fundus imaging or is likely to require surgery during the study period.\nAny of the following treatments to the study eye within 14 days prior to dosing: ranibizumab (Lucentis), bevacizumab (Avastin), pegaptanib (Macugen), or other VEGF inhibitor; OR likely requirement for one of the above treatments within 14 days of LFG316 administration.\nAny of the following within 30 days prior to dosing: photodynamic therapy treatment in the study eye; extrafoveal or juxtafoveal thermal laser photocoagulation in the study eye; systemic or topical (ophthalmic) steroid use in the study eye; bacterial keratitis in the study eye; OR intraocular surgery (including cataract surgery) in the fellow eye.\nAny of the following within 90 days prior to dosing: intraocular surgery (including cataract surgery) in the study eye; OR intravitreal or periocular corticosteroid injection in the study eye.\nParticipation in another interventional clinical study, or use of any experimental treatment for AMD or any other investigational new drug within 12 weeks prior to the start of study treatment. Clinical trials solely involving over-the-counter vitamins, supplements, or diets will not exclude the patients from study participation.\nAny medical condition likely to interfere with the patient's participation in the study, or likely to cause serious adverse events during the study.", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "MaximumAge":"80 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Rubens C Siqueira, MD,PhD", "OverallOfficialAffiliation":"University of Sao Paulo", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Rubens Siqueira Research Center", "LocationCity":"Sao Jose do Rio Preto", "LocationState":"SP", "LocationZip":"15010-100", "LocationCountry":"Brazil" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000008268", "ConditionMeshTerm":"Macular Degeneration" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000012162", "ConditionAncestorTerm":"Retinal Degeneration" },{ "ConditionAncestorId":"D000012164", "ConditionAncestorTerm":"Retinal Diseases" },{ "ConditionAncestorId":"D000005128", "ConditionAncestorTerm":"Eye Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M9843", "ConditionBrowseLeafName":"Macular Degeneration", "ConditionBrowseLeafAsFound":"Macular Degeneration", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M13580", "ConditionBrowseLeafName":"Retinal Degeneration", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13582", "ConditionBrowseLeafName":"Retinal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6854", "ConditionBrowseLeafName":"Eye Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC11", "ConditionBrowseBranchName":"Eye Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }