Actively Recruiting
Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Recurrent Glioblastoma or Recurrent Astrocytoma in Patients Undergoing Craniotomy
Led by Mayo Clinic · Updated on 2026-04-02
20
Participants Needed
1
Research Sites
214 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This phase I trial tests the safety, side effects, and best dose of allogenic adipose-derived mesenchymal stem cells (AMSCs) in treating patients with glioblastoma or astrocytoma that has come back (recurrent) who are undergoing brain surgery (craniotomy). Glioblastoma is the most common and most aggressive form of primary and malignant tumor of the brain. Currently, the standard of care for this disease includes surgical resection, followed by radiation with chemotherapy and tumor treating fields. Despite this aggressive therapy, the survival after finishing treatment remains low and the disease often reoccurs. Unfortunately, the available therapy options for recurrent glioblastoma are minimal and do not have a great effect on survival. AMSCs are found in body fat and when separated from the fat, are delivered into the surgical cavity at the time of surgery. When in direct contact with tumor cells, AMSCs affect tumor growth, residual tumor cell death, and chemotherapy resistance. The use of AMSCs delivered locally into the surgical cavity of recurrent glioblastoma during a craniotomy could improve the long-term outcomes of these patients by decreasing the progression rate and invasiveness of malignant cells.
CONDITIONS
Official 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 score of 60 or higher
- Negative pregnancy test within 7 days prior to registration for persons who can become pregnant
- Histological diagnosis of glioblastoma multiforme, IDH wildtype, or astrocytoma, IDH-mutant WHO grade IV
- Candidate for and scheduled to undergo redo craniotomy for excision of recurrent tumor
- Measurable disease according to immunotherapy response assessment in neuro-oncology (iRANO) criteria
- Serum creatinine and urea levels not exceeding 2 times the upper limit of normal within 3 weeks prior to registration
- ALT, AST, and alkaline phosphatase not exceeding 3 times the upper limit of normal, and bilirubin ≤ 2.5 mg/dL within 3 weeks prior to registration
- Prothrombin time ≤ 1.5 times the upper limit of normal within 3 weeks prior to registration
- INR and PTT ≤ 1.5 times the upper limit of normal within 3 weeks prior to registration
- Hemoglobin level ≥ 9 g/dL within 3 weeks prior to registration
- Platelet count ≥ 100 x 10^9/L within 3 weeks prior to registration
- Absolute neutrophil count ≥ 1.5 x 10^9/L within 3 weeks prior to registration
- Willingness to return to the enrolling institution for follow-up during the active monitoring phase
- Ability to understand and provide written and verbal consent for the protocol
- Willingness to provide mandatory blood, tissue, and cerebrospinal fluid specimens for correlative research
You will not qualify if you...
- Patients undergoing needle biopsy only or not eligible for surgical intervention
- Tumors located only in the brain stem, midbrain, or thalamus without involvement of surrounding brain tissue
- Previous treatment with bevacizumab
- Radiographic evidence of leptomeningeal disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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