{
  "FullStudy":{
    "Rank":218026,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513694",
          "OrgStudyIdInfo":{
            "OrgStudyId":"CSM/Fusión/2009"
          },
          "Organization":{
            "OrgFullName":"Red de Terapia Celular",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Clinical Trial Based on the Use of Mesenchymal Stem Cells From Autologous Bone Marrow in Patients With Lumbar Intervertebral Degenerative Disc Disease",
          "OfficialTitle":"Clinical Trial Phase I / II Prospective, Open, Non-randomized for Treatment of Lumbar Intervertebral Degenerative Disc Disease With Posterolateral Instrumented and Autologous Mesenchymal Stem Cells."
        },
        "StatusModule":{
          "StatusVerifiedDate":"May 2017",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2010"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"May 4, 2017",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"May 4, 2017",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 16, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"June 1, 2017",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"June 2, 2017",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Red de Terapia Celular",
            "LeadSponsorClass":"INDUSTRY"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Haematology Service,University Hospital of Salamanca, MªConsuelo del Cañizo Fernández-Roldán",
                "CollaboratorClass":"OTHER"
              },{
                "CollaboratorName":"Spanish National Health System",
                "CollaboratorClass":"OTHER"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this trial is to test the effectiveness of the use of a new therapeutic strategy in treating patients with degenerative disc disease lumbar intervertebral fusion with instrumented posterolateral autologous mesenchymal stem cells and arranged in a calcium phosphate ceramic (Conduit TM)."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Intervertebral Disc Disease"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Mesenchymal Stem Cells",
              "Stem Cells",
              "Intervertebral disc disease"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 1",
              "Phase 2"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"15",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"MSC seeded onto a phosphate ceramic",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Instrumented posterolateral fusion and autologous mesenchymal stem cells arranged in a phosphate ceramic.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: Instrumented posterolateral arthrodesis"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"Instrumented posterolateral arthrodesis",
                "InterventionDescription":"Cell suspension of mesenchymal stem cells (MSCs) obtained from bone marrow aspirate from the patient and expanded in vitro in a specific medium enriched with platelet lysate without addition of animal products.\n\nThey used a minimum dose of 0.5 x106 CSM / kg and a maximum of 1, 5x106 CSM / kg of patient weight.\n\nDosage Form: Suspension cell support hydroxyapatite and calcium phosphate Route of administration: placement in the fusion bed during surgery.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "MSC seeded onto a phosphate ceramic"
                  ]
                }
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nClinical\n\nBox symptomatic (back pain and / or root) of lumbar degenerative disc disease monosegmental.\nDiscopathy refractory to conservative treatment (drugs, physical therapy.)\nEvolution greater than or equal to 6 months. Radiological\nDiscopathy radiation. Disc space narrowing, osteophytes, abnormal mobility, etc\nNMR: grades IV and V of Pfirman.\n\nExclusion Criteria:\n\nRejection of surgical treatment.\nSystemic inflammatory disease (spondylitis, rheumatoid arthritis etc), tumor or infection.\nImmunosuppressive treatment.\nCongenital or acquired anatomical abnormality that prevents the surgical procedure.\nNeuropsychiatric pathology, drug addiction, psychosis, severe personality disorder.\nHigh surgical risk (ASA> IV), or contraindication to anesthesia.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"65 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Trauma Service. Hospital Universitario de Salamanca",
                "LocationCity":"Salamanca",
                "LocationState":"Castilla-León",
                "LocationZip":"37007",
                "LocationCountry":"Spain"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"30795797",
                "ReferenceType":"derived",
                "ReferenceCitation":"Blanco JF, Villarón EM, Pescador D, da Casa C, Gómez V, Redondo AM, López-Villar O, López-Parra M, Muntión S, Sánchez-Guijo F. Autologous mesenchymal stromal cells embedded in tricalcium phosphate for posterolateral spinal fusion: results of a prospective phase I/II clinical trial with long-term follow-up. Stem Cell Res Ther. 2019 Feb 22;10(1):63. doi: 10.1186/s13287-019-1166-4."
              }
            ]
          },
          "SeeAlsoLinkList":{
            "SeeAlsoLink":[
              {
                "SeeAlsoLinkLabel":"Spanish cell therapy network (TerCel)",
                "SeeAlsoLinkURL":"http://www.red-tercel.com"
              },{
                "SeeAlsoLinkLabel":"Salamanca University Foundation",
                "SeeAlsoLinkURL":"http://fundacion.usal.es"
              },{
                "SeeAlsoLinkLabel":"Spanish Health Institute Carlos III",
                "SeeAlsoLinkURL":"http://www.isciii.es"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000013122",
                "ConditionMeshTerm":"Spinal Diseases"
              },{
                "ConditionMeshId":"D000055959",
                "ConditionMeshTerm":"Intervertebral Disc Degeneration"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000001847",
                "ConditionAncestorTerm":"Bone Diseases"
              },{
                "ConditionAncestorId":"D000009140",
                "ConditionAncestorTerm":"Musculoskeletal Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M26992",
                "ConditionBrowseLeafName":"Intervertebral Disc Degeneration",
                "ConditionBrowseLeafAsFound":"Degenerative Disc Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M14502",
                "ConditionBrowseLeafName":"Spinal Diseases",
                "ConditionBrowseLeafAsFound":"Disc Disease",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M3708",
                "ConditionBrowseLeafName":"Bone Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10680",
                "ConditionBrowseLeafName":"Musculoskeletal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC05",
                "ConditionBrowseBranchName":"Muscle, Bone, and Cartilage Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}