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Suicide gene stem cells take aim at glioblastoma

NCT ID NCT07143812

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tests a new treatment called MSC11FCD for people with newly diagnosed glioblastoma, an aggressive brain cancer. The treatment uses donor stem cells that carry a 'suicide gene' and are injected into the brain during surgery to kill any remaining cancer cells. The study will enroll 10 patients to check if the treatment is safe and to find the best dose.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MSC11FCD (stem cells with a suicide gene)
What this could lead to
If it works, this could point toward a new way to kill leftover tumor cells after surgery and delay glioblastoma recurrence.
What could go wrong
This is a very early, small Phase 1 trial focused on safety, not effectiveness. The approach may not work in humans, and there are risks from the surgery and the stem cells themselves.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 10 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: * 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 who received Gliadel wafer implantation during surgery * 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 a Karnofsky Performance Scale (KPS) score \< 50 * 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) * Pregnant or breastfeeding women, patients planning to become pregnant during the study period, or those unwilling to use appropriate contraception * Participation in another clinical trial within 30 days prior to enrollment * Any condition that, in the opinion of the investigator, would make the patient unsuitable for study participation

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bundang CHA Medical Center

    RECRUITING

    Seongnam, Kyunggido, 13496, South Korea

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