Actively Recruiting
Clinical Research of Suicide Gene Expressing Allogenic Bone Marrow Derived Mesenchymal Stem Cells (MSC11FCD) in Patients With Newly Diagnosed Glioblastoma
Led by CHA University · Updated on 2026-01-22
10
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating MSC11FCD, an investigational allogeneic bone marrow-derived mesenchymal stem cell therapy that expresses a suicide gene, in patients with newly diagnosed glioblastoma, a highly aggressive brain tumor. This phase I clinical trial aims to assess the safety, tolerability, and maximum tolerated dose of MSC11FCD, which is given directly into the tumor site after surgical removal to target remaining tumor cells and potentially reduce early recurrence. The investigational treatment involves administering a single dose of MSC11FCD, delivered intratumorally in amounts of 1x10^7 or 3x10^7 cells during surgery using a syringe. The treatment is given immediately following tumor resection to explore its potential as a localized, targeted therapy during the postsurgical period. Participants will be monitored for up to 12 months after treatment to track any adverse events related to the therapy. Assessments include medical imaging and clinical evaluations to observe safety and tolerability. The study also aims to gather preliminary information on the treatment's effects, with ongoing follow-up to support patient safety and understand treatment impact over time.
CONDITIONS
Brief 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 years
- Newly diagnosed glioblastoma confirmed by medical imaging after standard therapy
- Expected survival of at least 3 months
- No prior immunotherapy treatments
- Provided informed consent or had legal guardian consent before participation
You will not qualify if you...
- Recurrent glioblastoma
- Known Dihydropyrimidine Dehydrogenase (DPD) deficiency
- Contraindications to contrast-enhanced MRI (e.g., pacemakers)
- Gliadel wafer implantation during surgery
- Severe dysfunction of major organs (liver, kidney, bone marrow, lung, heart)
- Other malignancies or cancer history within past 5 years
- Uncontrolled high or low blood pressure
- Serious infections including sepsis or hepatitis A, B, or C
- Karnofsky Performance Scale (KPS) score below 50
- Autoimmune diseases affecting the central nervous system
- Allergy to flucytosine (5-FC), its excipients, or 5-fluorouracil (5-FU)
- Pregnant or breastfeeding, or unwilling to use contraception during study
- Participation in another clinical trial within 30 days
- Any condition making the patient unsuitable for the study as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single day (surgery day)
Participants receive a single dose of the investigational stem cell-based gene therapy administered directly into the tumor site during surgery.
1 surgical visit (in-person)
Duration - Up to 12 months
Participants are monitored for safety and adverse events for up to 12 months after treatment administration.
Regular follow-up visits over 12 months
Trial Site Locations
Total: 1 location
1
Bundang CHA Medical Center
Seongnam, Kyunggido, South Korea, 13496
Actively Recruiting
Research Team
J
Jaejoon Lim, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here