[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100603999":3},{"organization":4,"armGroups":7,"interventions":13,"overallOfficials":20,"centralContacts":24,"locations":29,"responsibleParty":47,"collaborators":19,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":19,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":19,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":32,"whyStopped":19,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"CHA University","OTHER",[8],{"label":9,"type":6,"description":10,"interventionNames":11},"The investigational drug into the Intratumoral administration","The investigational drug in the amount of 1x10\\^7, 3x10\\^7cells per dose into the tumor or the tumor removal site using a syringe during surgery",[12],"Drug: MSC11FCD",[14],{"type":15,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","MSC11FCD","Administration period: Single dose Route of administration: Intratumoral administration Dose: 1x10\\^7, 3x10\\^7cells\u002Fdose Summary: Administer the investigational drug in the amount of 1x10\\^7, 3x10\\^7cells per dose into the tumor or the tumor removal site using a syringe during surgery.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Jaejoon Lim, PhD","PRINCIPAL_INVESTIGATOR",[25],{"name":22,"role":26,"phone":27,"phoneExt":19,"email":28},"CONTACT","+82-31-780-5688","einses218@gmail.com",[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":19,"cosmosGeoPoint":37,"geoPoint":42,"contacts":43},"Bundang CHA Medical Center","RECRUITING","Seongnam","Kyunggido","13496","South Korea",{"type":38,"coordinates":39},"Point",[40,41],127.7548,36.4052,{"lat":41,"lon":40},[44],{"name":45,"role":26,"phone":46,"phoneExt":19,"email":28},"Jaejoon Lim, M.D., Ph.D","82-31-780-5688",{"type":48,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100603999","phase-1-a-study-to-evaluate-the-safety-of-a-stem-cell-based-gene-and-cell-therapy-in-patients-with-newly-diagnosed-glioblastoma-100603999",false,"NCT07143812","A Study to Evaluate the Safety of a Stem Cell-Based Gene and Cell Therapy in Patients With Newly Diagnosed Glioblastoma","Clinical Research of Suicide Gene Expressing Allogenic Bone Marrow Derived Mesenchymal Stem Cells(MSC11FCD) in Patients With Newly Diagnosed Glioblastoma","Inclusion Criteria:\n\n* Patients aged 19 to 70\n* Patients diagnosed with newly diagnosed glioblastoma based on medical imaging after receiving standard therapy for glioblastoma\n* Patients whose expected survival period is at least 3 months\n* Patients who have not received any other types of immunotherapy\n* Patients who have been given a sufficient explanation of the purpose and details of the clinical trial and the characteristics of the investigational drug from an investigator and who signed the consent form or had a legal guardian or representative sign the consent form prior to the beginning of this clinical trial\n\nExclusion Criteria:\n\n* Patients with recurrent glioblastoma. Known Dihydropyrimidine Dehydrogenase (DPD) deficiency Contraindications to contrast-enhanced MRI (e.g., patients with pacemakers or other reasons preventing MRI scans according to the study schedule)\n* Patients who received Gliadel wafer implantation during surgery\n* Patients with severe dysfunction of major organs (liver, kidney, bone marrow, lung, heart) as determined by the investigator\n* Patients with concurrent malignancies other than glioblastoma or a history of malignancy within the past 5 years\n* Patients with uncontrolled hypotension or hypertension\n* Patients with serious infections as determined by the investigator, including sepsis, hepatitis A, B, or C\n* Patients with a Karnofsky Performance Scale (KPS) score \\\u003C 50\n* Patients with autoimmune diseases involving the central nervous system (e.g., multiple sclerosis, myasthenia gravis, acute disseminated encephalomyelitis)\n* Patients with a history of allergy to flucytosine (5-FC), its excipients, or 5-fluorouracil (5-FU)\n* Pregnant or breastfeeding women, patients planning to become pregnant during the study period, or those unwilling to use appropriate contraception\n* Participation in another clinical trial within 30 days prior to enrollment\n* Any condition that, in the opinion of the investigator, would make the patient unsuitable for study participation","ALL","19 Years","70 Years",{"count":60,"type":61},10,"ESTIMATED","INTERVENTIONAL",[64],"PHASE1","This is a phase I clinical trial evaluating the safety, tolerability, and maximum tolerated dose of MSC11FCD, an investigational allogeneic bone marrow-derived mesenchymal stem cell therapy expressing a suicide gene, in patients with newly diagnosed glioblastoma. The investigational product is administered intratumorally following surgical resection. This study aims to explore whether MSC11FCD can provide a targeted, localized treatment option during the postsurgical period, potentially addressing residual tumor cells and reducing early recurrence.",[67,68],"Glioblastoma (GBM)","Newly Diagnosed Glioblastoma Multiforme",[70,71,72,73],"Glioblastoma","mesenchymal stem cell","gene therapy","suicide gene","2026-01-20",{"date":76,"type":77},"2026-01-22","ACTUAL",{"date":79,"type":77},"2025-10-23",{"date":81,"type":61},"2026-12-31",{"name":5,"class":6},1]