[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648453":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":19,"locations":29,"responsibleParty":66,"collaborators":11,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":11,"eligibilityCriteria":74,"healthyVolunteers":70,"sex":75,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":11,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":90,"whyStopped":11,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Kringle Pharma, Inc.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"KP-100IT","EXPERIMENTAL",null,[13],"Drug: KP-100IT",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":11},"DRUG","The contents of each vial were dissolved in the distilled water for injection, and the study drug (0.6 mg as KP-100) was administered intrathecally once per week a total of 5 times.",[9],[20,25],{"name":21,"role":22,"phone":23,"phoneExt":11,"email":24},"Daichika Hayata","CONTACT","'+81-6-7653-6728","hayata@kringle-pharma.com",{"name":26,"role":22,"phone":27,"phoneExt":11,"email":28},"Yurika Abe","+81-6-7653-6728","y.abe@kringle-pharma.com",[30,46,56],{"facility":31,"status":11,"city":32,"state":33,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Japan Organization for Occupational Health and Safety Comprehensive Spinal Cord Injuries Center","Iizuka","Fukuoka","820-8508","Japan","JP",{"type":38,"coordinates":39},"Point",[40,41],130.68678,33.63654,{"lat":41,"lon":40},[44],{"name":11,"role":22,"phone":45,"phoneExt":11,"email":11},"+81-948-24-7500",{"facility":47,"status":11,"city":48,"state":49,"zip":50,"country":35,"countryCode":36,"cosmosGeoPoint":51,"geoPoint":55,"contacts":11},"Japan Organization for Occupational Health and Safety Hokkaido Spinal Cord Injury Center","Bibai","Hokkaido","072-0015",{"type":38,"coordinates":52},[53,54],141.85861,43.32472,{"lat":54,"lon":53},{"facility":57,"status":11,"city":58,"state":59,"zip":60,"country":35,"countryCode":36,"cosmosGeoPoint":61,"geoPoint":65,"contacts":11},"National Hospital Organization Murayama Medical Center","Musashimurayama","Tokyo","208-0011",{"type":38,"coordinates":62},[63,64],139.42635,35.74242,{"lat":64,"lon":63},{"type":67,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100648453","phase-3-additional-phase-3-study-of-kp-100it-in-subjects-with-acute-spinal-cord-injury-100648453",false,"NCT07722962","Additional Phase 3 Study of KP-100IT in Subjects With Acute Spinal Cord Injury","An Additional Phase 3, Multicenter Study of Intrathecal Administration of KP-100IT in Subjects With Acute Spinal Cord Injury","Inclusion Criteria:\n\n* Patients whose AIS grade is A at 72 hours (± 6 hours) after injury\n* age: 18 years to 89 years\n* MRI imaging and other tests confirm the continuity of the spinal cord\n\nExclusion Criteria:\n\n* The injury site is C1-C2 or C2-C3\n* The patient with a spinal crd compression rate of 70% or higher.\n* The patient in whom a spinal cord rupture is strongle suspected.\n* The patient cannot start rehabilitation necessary for recovery of function at an early stage.\n* External trauma or concurrent organ injury.\n* High dose steroid therapy administered for the treatment of spinal cord injury\n* History or concurrent presence of malignant tumor.\n* It is inappropriate for the subject to be included in the study, in the opinion of the investigator.","ALL","18 Years","89 Years",{"count":79,"type":80},10,"ESTIMATED","INTERVENTIONAL",[83],"PHASE3","This is a Phase 3, multicenter, open-label, single-arm additional study to evaluate the efficacy of intrathecal KP-100IT in patients with acute spinal cord injury. Eligible patients will receive KP-100 0.6 mg\u002Fbody by intrathecal administration once per week for a total of 5 doses and will be followed for approximately 24 weeks after the first dose.",[86],"Acute Spinal Cord Injury (SCI)",[9,88,89],"Hepatocyte growth factor","Intrathecal administration","NOT_YET_RECRUITING","2026-07-20",{"date":93,"type":94},"2026-07-23","ACTUAL",{"date":96,"type":80},"2026-07-31",{"date":98,"type":80},"2028-12-31",{"name":5,"class":6},3]