OncoMatch/Clinical Trials/NCT05789394
Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Recurrent Glioblastoma or Recurrent Astrocytoma in Patients Undergoing Craniotomy
Is NCT05789394 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies Allogeneic Adipose-derived Mesenchymal Stem Cells for recurrent glioblastoma, idh-wildtype.
Treatment: Allogeneic Adipose-derived Mesenchymal Stem Cells — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Glioblastoma
Biomarker criteria
Required: IDH1 wild-type
glioblastoma multiforme, isocitrate dehydrogenase (IDH) wildtype (WT)
Required: IDH2 wild-type
glioblastoma multiforme, isocitrate dehydrogenase (IDH) wildtype (WT)
Required: IDH1 mutation
astrocytoma, IDH-mutant World Health Organization (WHO) grade IV
Required: IDH2 mutation
astrocytoma, IDH-mutant World Health Organization (WHO) grade IV
Disease stage
Required: Stage WHO GRADE IV (WHO 2021 CNS)
Grade: IV (WHO)
measurable disease according to the immunotherapy response assessment in neuro-oncology (iRANO) criteria
Prior therapy
Cannot have received: vegf inhibitor (bevacizumab)
Lab requirements
Blood counts
hemoglobin >= 9 g/dL; platelets >= 100 x 10^9/L; ANC >= 1.5 x 10^9/L (<= 3 weeks prior to registration)
Kidney function
serum creatinine and urea <= 2x ULN (<= 3 weeks prior to registration)
Liver function
ALT, AST, and alkaline phosphatase <= 3x ULN; bilirubin <= 2.5 mg/dL (<= 3 weeks prior to registration)
Serum creatinine and urea <= 2 times the upper limit of normal (<= 3 weeks prior to registration); ALT, AST and alkaline phosphatase <= 3 times the upper limit of normal, and bilirubin <= 2.5 mg/dL (<= 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)
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic in Florida · Jacksonville, Florida
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