Fat-Derived stem cells injected into brain during surgery to fight glioblastoma
NCT ID NCT05789394
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2023
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Mayo Clinic in Florida
RECRUITINGJacksonville, Florida, 32224-9980, United States
Contact Email: •••••@•••••
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