NCT07143812RecruitingPhase 1
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
Source: ClinicalTrials.gov · Last updated 22 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 4 Aug 2025
- Start date
- 23 Oct 2025
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- CHA University
- Diseases
- Glioblastoma
- NCT number
- NCT07143812
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 10
- From 23 Oct 2025 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients who received Gliadel wafer implantation during surgery
- Participation in another clinical trial within 30 days prior to enrollment
Other illness
- Patients with severe dysfunction of major organs (liver, kidney, bone marrow, lung, heart) as determined by the investigator
- Patients with concurrent malignancies other than glioblastoma or a history of malignancy within the past 5 years
- Patients with uncontrolled hypotension or hypertension
- Patients with serious infections as determined by the investigator, including sepsis, hepatitis A, B, or C
- Patients with autoimmune diseases involving the central nervous system (e.g., multiple sclerosis, myasthenia gravis, acute disseminated encephalomyelitis)
- Patients with a history of allergy to flucytosine (5-FC), its excipients, or 5-fluorouracil (5-FU)
- Any condition that, in the opinion of the investigator, would make the patient unsuitable for study participation
Other
- 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)
- Patients with a Karnofsky Performance Scale (KPS) score \< 50
- Pregnant or breastfeeding women, patients planning to become pregnant during the study period, or those unwilling to use appropriate contraception
Who the study is looking for
- Patients aged 19 to 70
- Patients diagnosed with newly diagnosed glioblastoma based on medical imaging after receiving standard therapy for glioblastoma
- Patients whose expected survival period is at least 3 months
- Patients who have not received any other types of immunotherapy
- 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
Age in the registry: 19 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bundang CHA Medical Center Coordinator of this site? Confirm its status | Seongnam | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.