Actively Recruiting
A Study to Evaluate the Safety of a Stem Cell-Based Gene and Cell Therapy in Patients With Newly Diagnosed Glioblastoma
Led by CHA University · Updated on 2026-01-22
10
Participants Needed
1
Research Sites
62 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Safety of a Stem Cell-Based Gene and Cell Therapy in Patients With Newly Diagnosed Glioblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 19 to 70
- Diagnosed with newly diagnosed glioblastoma based on medical imaging after standard therapy
- Expected survival of at least 3 months
- Have not received any other types of immunotherapy
- Provided informed consent prior to starting the trial
You will not qualify if you...
- Recurrent glioblastoma
- Known Dihydropyrimidine Dehydrogenase (DPD) deficiency
- Contraindications to contrast-enhanced MRI (e.g., pacemakers or other reasons preventing MRI scans)
- Received Gliadel wafer implantation during surgery
- Severe dysfunction of major organs (liver, kidney, bone marrow, lung, heart)
- Concurrent malignancies other than glioblastoma or history of malignancy within the past 5 years
- Uncontrolled hypotension or hypertension
- Serious infections including sepsis, hepatitis A, B, or C
- Karnofsky Performance Scale score less than 50
- Autoimmune diseases affecting the central nervous system (e.g., multiple sclerosis, myasthenia gravis, acute disseminated encephalomyelitis)
- Allergy to flucytosine (5-FC), its excipients, or 5-fluorouracil (5-FU)
- Pregnant or breastfeeding, planning pregnancy, or unwilling to use contraception during the study
- Participation in another clinical trial within 30 days prior to enrollment
- Any condition making the patient unsuitable for study participation in investigator's opinion
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Bundang CHA Medical Center
Seongnam, Kyunggido, South Korea, 13496
Actively Recruiting
Research Team
J
Jaejoon Lim, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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