Using fat-derived stem cells to treat recurrent brain tumors during surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase I trial evaluates the safety and optimal dosage of allogenic adipose-derived mesenchymal stem cells (AMSCs) in patients with recurrent glioblastoma or astrocytoma undergoing craniotomy. The study aims to determine the maximum tolerated dose of AMSCs delivered directly into the tumor site during surgery. Secondary objectives include assessing the safety profile, overall survival, and progression-free survival of participants. Additionally, the trial will explore the immune response and local brain tissue changes post-treatment through various analyses.

Why it matters

Who can join: the full rules

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

Where it's running

• Mayo Clinic in Florida
  Jacksonville, Florida, United States Recruiting

Study contacts

• Principal investigator: Alfredo Quinones-Hinojosa, MD — Mayo Clinic
• Study coordinator: Clinical Trials Referral Office
• Email: mayocliniccancerstudies@mayo.edu
• Phone: 855-776-0015

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.