Using fat-derived stem cells to treat recurrent brain tumors during surgery
Phase 1, Dose Escalation, Non-Randomized, Open Label, Clinical Trial Evaluating the Safety and Preliminary Efficacy of Allogenic Adipose-Derived Mesenchymal Stem Cells (AMSCs) for Recurrent Glioblastoma
This study is testing whether injecting fat-derived stem cells directly into the brain during surgery can help people with recurrent brain tumors feel better and live longer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | bevacizumab, immunotherapy, chemotherapy, radiation |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT05789394 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of recurrent glioblastoma or astrocytoma who are scheduled for craniotomy.
Not a fit: Patients with non-recurrent brain tumors or those who do not meet the eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve survival rates and treatment outcomes for patients with recurrent glioblastoma and astrocytoma.
How similar studies have performed: While the use of stem cells in treating brain tumors is an emerging field, this specific approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Jacksonville, Florida
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.