{
  "FullStudy":{
    "Rank":217634,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01518842",
          "OrgStudyIdInfo":{
            "OrgStudyId":"Siqueira Research Center"
          },
          "Organization":{
            "OrgFullName":"University of Sao Paulo",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy",
          "OfficialTitle":"Effect of Intravitreal Bone Marrow Stem Cells on Ischemic Retinopathy",
          "Acronym":"RetinaCell"
        },
        "StatusModule":{
          "StatusVerifiedDate":"October 2018",
          "OverallStatus":"Active, not recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"September 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"October 2018",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"January 2020",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 22, 2012",
          "StudyFirstSubmitQCDate":"January 25, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"October 15, 2018",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"October 16, 2018",
            "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":"This study aims to evaluate the behavior of the intravitreal use of bone marrow derived stem cells in patients with ischemic retinopathy.",
          "DetailedDescription":"Evaluate the effects on visual acuity, electroretinography, fluorescein angiography and optical coherence tomography in 30 patients with ischemic retinopathy, including diabetic retinopathy with severe loss of retinal capillaries undergoing intravitreal injection of bone marrow derived stem cells."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Ischemia"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "ischemic retinopathy, stem cell,bone marrow"
            ]
          }
        },
        "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":"30",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"test group intravitreal stem cell",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Open-label study of Ischemic Retinopathy patients with best-corrected visual acuity (BCVA) worse than 20/200.\n\nIntervention: Biological: intravitreal injection of autologous bone marrow stem cells",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Biological: Intravitreal Bone Marrow Stem Cells"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Biological",
                "InterventionName":"Intravitreal Bone Marrow Stem Cells",
                "InterventionDescription":"One intravitreal injection of a 0.1-ml cell suspension containing around 10x106 bone marrow mononuclear stem cells(BMMSC). All treatments were performed by a single retinal specialist using topical proparacaine drops under sterile conditions (eyelid speculum and povidone-iodine). Autologous BMMSC were injected into the vitreous cavity using a 27 gauge needle inserted through the inferotemporal pars plana 3.0 - 3.5 mm posterior to the limbus. After the injection, central retinal artery perfusion was confirmed with indirect ophthalmoscopy. Patients were instructed to instill one drop of 0.3% ciprofloxacin into the injected eye four times daily for 1 week after the procedure.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "test group intravitreal stem cell"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Change in size of FAZ at 48 weeks",
                "PrimaryOutcomeTimeFrame":"1 day to 48 weeks"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Change in central foveal thickness and best corrected visual acuity at 48 weeks",
                "SecondaryOutcomeTimeFrame":"1 day to 48 weeks"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\ndiagnosis of Ischemic Retinopathy\nEnlargement of foveal avascular zone-FAZ (ischaemia or capillary drop out of >30% on Fluorescein retinography\nlogarithm of minimum angle of resolution (logMAR) BCVA of 1.0 (Snellen equivalent, 20/200) or worse\nAble (in the Investigator's opinion) and willing to comply with all study requirements\n\nExclusion Criteria:\n\nprevious ocular surgery other than cataract\npresence of cataract or other media opacity that would influence ocular fundus documentation and adequate ERG and visual field evaluation\nother ophthalmic disease like glaucoma and uveitis\nprevious history of blood disorders like leukemia\nknown allergy to fluorescein or indocyanine green",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"70 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Rubens C Siqueira, MD, PhD",
                "OverallOfficialAffiliation":"Rubens Siqueira Research Center",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Rubens Siqueira Research Center",
                "LocationCity":"Sao Jose do Rio Preto",
                "LocationState":"SP",
                "LocationZip":"15010-100",
                "LocationCountry":"Brazil"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"24954079",
                "ReferenceType":"background",
                "ReferenceCitation":"Siqueira RC, Messias A, Gurgel VP, Simões BP, Scott IU, Jorge R. Improvement of ischaemic macular oedema after intravitreal injection of autologous bone marrow-derived haematopoietic stem cells. Acta Ophthalmol. 2015 Mar;93(2):e174-6. doi: 10.1111/aos.12473. Epub 2014 Jun 22."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000012164",
                "ConditionMeshTerm":"Retinal Diseases"
              },{
                "ConditionMeshId":"D000007511",
                "ConditionMeshTerm":"Ischemia"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000010335",
                "ConditionAncestorTerm":"Pathologic Processes"
              },{
                "ConditionAncestorId":"D000005128",
                "ConditionAncestorTerm":"Eye Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M9126",
                "ConditionBrowseLeafName":"Ischemia",
                "ConditionBrowseLeafAsFound":"Ischemia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M13582",
                "ConditionBrowseLeafName":"Retinal Diseases",
                "ConditionBrowseLeafAsFound":"Retinopathy",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M6854",
                "ConditionBrowseLeafName":"Eye Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC11",
                "ConditionBrowseBranchName":"Eye Diseases"
              }
            ]
          }
        }
      }
    }
  }
}