Actively Recruiting
Phase 1 Dose Escalation Study Evaluating Safety and Preliminary Efficacy of Allogenic Adipose-Derived Mesenchymal Stem Cells for Recurrent Glioblastoma
Led by Mayo Clinic · Updated on 2026-04-02
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, side effects, and best dose of allogenic adipose-derived mesenchymal stem cells (AMSCs) for patients with recurrent glioblastoma or astrocytoma undergoing brain surgery. Glioblastoma is the most common and aggressive brain tumor, and despite standard treatments like surgery, radiation, chemotherapy, and tumor treating fields, survival remains low with frequent recurrence. This phase I trial aims to explore whether AMSCs delivered directly into the surgical cavity during craniotomy can affect tumor growth and improve outcomes. Participants receive AMSCs injected into the tumor area during a craniotomy, along with placement of an Ommaya reservoir to collect cerebrospinal fluid (CSF). Patients undergo magnetic resonance imaging (MRI) and provide blood, tissue, and CSF samples throughout the study. The study follows a dose-escalation design to determine the maximum tolerated dose of AMSCs. During the trial, participants are monitored closely with MRI scans and sample collections to assess safety, immune response, and tumor behavior. Follow-up visits occur every two months for one year to evaluate adverse effects, progression-free survival, and overall survival. The research also looks at changes in brain tissue over time and presence of AMSCs at recurrence, with safety monitored up to five years.
CONDITIONS
Brief Title
Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Recurrent Glioblastoma or Recurrent Astrocytoma in Patients Undergoing Craniotomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants 18 years or older
- Karnofsky Performance Scale (KPS) score of 60 or higher
- Negative pregnancy test within 7 days before registration for persons of childbearing potential
- Previous diagnosis of glioblastoma multiforme, IDH wildtype, or astrocytoma, IDH-mutant WHO grade IV
- Candidates for and will undergo craniotomy for recurrent tumor removal
- Measurable disease per immunotherapy response assessment in neuro-oncology (iRANO) criteria
- Serum creatinine and urea no more than twice the upper limit of normal within 3 weeks prior to registration
- Liver enzymes (ALT, AST, alkaline phosphatase) no more than three times upper limit, bilirubin ≤ 2.5 mg/dL within 3 weeks prior
- Prothrombin time ≤ 1.5 times upper limit within 3 weeks prior
- INR and PTT ≤ 1.5 times upper limit within 3 weeks prior
- Hemoglobin ≥ 9 g/dL within 3 weeks prior
- Platelets ≥ 100 x 10^9/L within 3 weeks prior
- Absolute neutrophil count ≥ 1.5 x 10^9/L within 3 weeks prior
- Willing to return for follow-up visits during monitoring phase
- Able to provide informed consent or have legally authorized representative
- Willing to provide blood, tissue, and cerebrospinal fluid samples for research
- Willing to undergo Ommaya reservoir placement
You will not qualify if you...
- Patients undergoing needle biopsy only or not eligible for surgery
- Tumors located only in brain stem, midbrain, or thalamus without surrounding brain involvement
- Prior treatment with bevacizumab
- Radiographic evidence of leptomeningeal disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 4 weeks
Participants undergo craniotomy with placement of an Ommaya reservoir and receive allogeneic adipose-derived mesenchymal stem cells (AMSCs) injected into the tumor. Blood, tissue, and cerebrospinal fluid samples are collected, and MRI scans are performed during treatment.
1 surgical visit and multiple assessments during hospital stay
Duration - 1 year
After treatment, participants are followed up every 2 months for 1 year to monitor safety, assess disease progression, and perform MRI scans and sample collections as needed.
Visits every 2 months for up to 1 year
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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