None listed
Conditions
Interventions
Biological/Vaccine, Stem Cell : 1) Drug Name:
Genetically Modified Allogeneic Bone Marrow-Derived Mesenchymal Stem Cells (MSC11FCD)
2) Dosage:
Cohort 1: 1.0 × 10,000,000 cells/kg
Cohort 2: 3.0 × 10,0
Sponsors
Bundang CHA General Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults aged 19 to 70 years 2. Patients diagnosed with glioblastoma 3. Individuals with an expected survival of at least 3 months 4. Patients not receiving any other immunotherapy 5. Patients (or their legal guardian/representative) who have provided written informed consent after receiving a thorough explanation from the investigator regarding the purpose, details of the study, and characteristics of the investigational product before the initiation of the clinical trial.
Exclusion criteria
Exclusion criteria: 1. Patients with recurrent glioblastoma 2. Patients with known dihydropyrimidine dehydrogenase (DPD) deficiency 3. Patients with contraindications to contrast-enhanced MRI (e.g., those with a pacemaker or other conditions preventing MRI scans according to the clinical trial schedule) 4. Patients who have received Gliadel wafer implantation during surgery 5. Patients with severe dysfunction of major organs (liver, kidney, bone marrow, lungs, or heart) as determined by the investigator 6. Patients with concurrent malignant tumors other than glioblastoma or a history of malignancy within the past five years 7. Patients with uncontrolled hypotension or hypertension 8. Patients with severe infections, including sepsis, hepatitis B, or hepatitis C, as determined by the investigator 9. Patients with a Karnofsky Performance Scale (KPS) score < 50 10. Patients with autoimmune diseases affecting the central nervous system, such as multiple sclerosis, myasthenia gravis, or acute disseminated encephalomyelitis (ADEM) 11. Patients with a history of allergy to flucytosine (5-FC), its excipients, or 5-fluorouracil (5-FU) 12. Pregnant or breastfeeding women, or those who plan to become pregnant during the clinical trial and do not agree to use an appropriate method of contraception 13. Individuals who have participated in another clinical trial within 30 days prior to enrollment 14. Patients deemed unsuitable for participation by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Event | — |
Secondary
| Measure | Time frame |
|---|---|
| clinical laboratory tests, Clinical assessment, Radiological assessment | — |
Countries
Korea, Republic of
Contacts
Public ContactYoungSoon Ahn
Bundang CHA General Hospital
Outcome results
None listed