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Fat-Derived stem cells injected into brain during surgery to fight glioblastoma

NCT ID NCT05789394

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests whether stem cells taken from fat tissue can be safely injected into the brain during surgery for recurrent glioblastoma. The stem cells are meant to attack remaining tumor cells and make them more sensitive to chemotherapy. About 20 adults whose brain cancer has returned will receive the treatment, and researchers will look for side effects and the best dose to use.

What this could mean

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

Active substance
allogeneic adipose-derived mesenchymal stem cells (AMSCs)
What this could lead to
If it works, this could point toward a new way to slow or stop recurrent glioblastoma by delivering stem cells directly into the brain during surgery.
What could go wrong
This is a very early Phase 1 trial with only 20 people, focused on safety and dosing. It may not show any benefit, and there are risks from the surgery and the stem cell injection itself.

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 20 people

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

Started

Jun 2023

Expected to finish

Jul 2027

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

18 years and older

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: * Participants \>= 18 years * Karnofsky Performance Scale (KPS) \>= 60 * Negative pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only * Patients with a previous histological diagnosis of glioblastoma multiforme, isocitrate dehydrogenase (IDH) wildtype (WT) or astrocytoma, IDH-mutant World Health Organization (WHO) grade IV according to the 2021 WHO classification of tumors of the central nervous system , who are candidates to- and will undergo a redo craniotomy for excision of recurrent tumor * There is measurable disease according to the immunotherapy response assessment in neuro-oncology (iRANO) criteria * Serum creatinine and urea \<= 2 times the upper limit of normal (=\< 3 weeks prior to registration) * Alanine transaminase (ALT), aspartate transferase (AST) and alkaline phosphatase =\< 3 times the upper limit of normal, and bilirubin =\< 2.5 mg/dL (=\< 3 weeks prior to registration) * Prothrombin time =\< 1.5 times upper limit of normal (=\< 3 weeks prior to registration) * International normalized ratio (INR) and partial thromboplastin time (PTT) =\< 1.5 times the upper limit of normal (=\< 3 weeks prior to registration) * Hemoglobin \>= 9 g/dL (=\< 3 weeks prior to registration) * Platelets \>= 100 x 10\^9/L (=\< 3 weeks prior to registration) * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (=\< 3 weeks prior to registration) * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) * Patient or legally authorized representative (LAR) is able to fully understand and provide written and verbal consent for the protocol * Willingness to provide mandatory blood specimens for correlative research * Willingness to provide mandatory tissue specimens for correlative research * Willingness to undergo Ommaya reservoir placement and provide cerebrospinal fluid (CSF) samples for correlative research Exclusion Criteria: * Patients who are undergoing needle biopsy only or non-eligible for a surgical intervention * Tumors located solely in the brain stem, midbrain, or thalamus without inclusion/involvement of surrounding brain matter * Previous treatment with bevacizumab * Radiographic evidence of leptomeningeal disease

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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 study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

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

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Mayo Clinic in Florida

    RECRUITING

    Jacksonville, Florida, 32224-9980, United States

    Contact Email: •••••@•••••

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