{
  "FullStudy":{
    "Rank":218275,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510431",
          "OrgStudyIdInfo":{
            "OrgStudyId":"CRD 620"
          },
          "Organization":{
            "OrgFullName":"Mesoblast, Ltd.",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Safety and Treatment Outcome Study of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease",
          "OfficialTitle":"An Open-label Compassionate Treatment Protocol to Evaluate the Safety and Treatment Outcomes of PROCHYMAL® (Remestemcel-L) Intravenous Infusion in Subjects With Treatment-resistant Crohn's Disease"
        },
        "StatusModule":{
          "StatusVerifiedDate":"March 2020",
          "OverallStatus":"No longer available",
          "StudyFirstSubmitDate":"January 9, 2012",
          "StudyFirstSubmitQCDate":"January 11, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 16, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"March 6, 2020",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"March 10, 2020",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Mesoblast, Inc.",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{},
        "DescriptionModule":{
          "BriefSummary":"Protocol 620 provides PROCHYMAL(R) adult human mesenchymal cells to specifically chosen Crohn's disease patients at participating centers who typically have already demonstrated good response in another PROCHYMAL study, are not eligible for other PROCHYMAL studies, and in the view of the investigator, would not benefit significantly from other Crohn's therapies but would benefit from use of PROCHYMAL.\n\nThe study is not placebo-controlled or randomized."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Crohn's Disease"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Expanded Access",
          "ExpandedAccessTypes":{
            "ExpAccTypeIntermediate":"Yes"
          }
        },
        "ArmsInterventionsModule":{
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"PROCHYMAL (remestemcel-L)",
                "InterventionDescription":"intravenous administration of 200 million cells on days 0, 3, 7, and 14, and then, at investigator discretion, periodically thereafter"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\ncurrently active moderate-to-severe Crohn's disease\nexhausted standard-of-care options\nage 18 to 70 inclusive\nbody weight between 30 and 150 kg\nadequate renal function\nnot at risk for tuberculosis (TB) activation or re-activation\n\nExclusion Criteria:\n\nbiologic therapy for Crohn's within last 8 weeks\nconfirmed adverse reactions during prior PROCHYMAL study participation\nalcohol or substance abuse, current or within past 6 months\nactive HIV or hepatitis B or C infection\nsurgery or trauma with 6 weeks\nallergy to bovine or porcine products\nelevated serum liver enzymes\nelevated serum bilirubin\nactive malignancy within 5 years (other than some resected skin cancers)\nbacteremia or other serious bacterial or fungal infection within 3 months\ncolonic dysplasia\nunstable arrhythmia or serious heart condition",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"70 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Mahboob Rahman, MD",
                "OverallOfficialAffiliation":"Mesoblast, Inc.",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Unviersity of California, San Francisco",
                "LocationCity":"San Francisco",
                "LocationState":"California",
                "LocationZip":"94115",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"Stormont-Vail",
                "LocationCity":"Topeka",
                "LocationState":"Kansas",
                "LocationZip":"66606",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"Mount Sinai Hospital",
                "LocationCity":"New York",
                "LocationState":"New York",
                "LocationZip":"10128",
                "LocationCountry":"United States"
              },{
                "LocationFacility":"Vanderbilt University Medical Center",
                "LocationCity":"Nashville",
                "LocationState":"Tennessee",
                "LocationZip":"37232-2285",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000003424",
                "ConditionMeshTerm":"Crohn Disease"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000015212",
                "ConditionAncestorTerm":"Inflammatory Bowel Diseases"
              },{
                "ConditionAncestorId":"D000005759",
                "ConditionAncestorTerm":"Gastroenteritis"
              },{
                "ConditionAncestorId":"D000005767",
                "ConditionAncestorTerm":"Gastrointestinal Diseases"
              },{
                "ConditionAncestorId":"D000004066",
                "ConditionAncestorTerm":"Digestive System Diseases"
              },{
                "ConditionAncestorId":"D000007410",
                "ConditionAncestorTerm":"Intestinal Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M5221",
                "ConditionBrowseLeafName":"Crohn Disease",
                "ConditionBrowseLeafAsFound":"Crohn's Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9027",
                "ConditionBrowseLeafName":"Intestinal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M16500",
                "ConditionBrowseLeafName":"Inflammatory Bowel Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7458",
                "ConditionBrowseLeafName":"Gastroenteritis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7466",
                "ConditionBrowseLeafName":"Gastrointestinal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5838",
                "ConditionBrowseLeafName":"Digestive System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC06",
                "ConditionBrowseBranchName":"Digestive System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}