Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Recurrent Glioblastoma or Recurrent Astrocytoma in Patients Undergoing Craniotomy

Recruiting now · Phase 1

Conditions studied: Recurrent Glioblastoma, IDH-Wildtype, Recurrent Astrocytoma, IDH-Mutant, Grade 4, Astrocytoma, Grade IV

In brief

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.

Key facts

Study ID: NCT05789394
Run by: Mayo Clinic
People needed: 20
Starts: 2023-06-16
Expected to finish: 2027-07-24
Last updated by the study team: 2026-04-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

Mayo Clinic in Florida — Jacksonville, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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