Recruiting
Phase 1

Adipose-Derived Stem Cells

Sponsor:

Mayo Clinic

Code:

NCT05789394

Conditions

Recurrent Glioblastoma, IDH-Wildtype

Recurrent Astrocytoma, IDH-Mutant, Grade 4

Astrocytoma, Grade IV

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Allogeneic Adipose-derived Mesenchymal Stem Cells

Biospecimen Collection

Craniotomy

Magnetic Resonance Imaging

Ommaya Reservoir Tap

Study Details

Brief summary:

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

Recurrent Glioblastoma, IDH-Wildtype

Recurrent Astrocytoma, IDH-Mutant, Grade 4

Astrocytoma, Grade IV

Study ID

NCT05789394

Start date

Jun 16, 2023

Status verified date

Mar, 2026

Completion date

Jul 24, 2027

Anticipated

Primary completion date

Jul 24, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (AMSCs)

Patients receive AMSCs IT and undergo Ommaya reservoir placement during a craniotomy on study. Patients also undergo MRI on study and during follow-up, as well as blood sample, tissue sample, and CSF sample collection on study.

Interventions

Allogeneic Adipose-derived Mesenchymal Stem Cells

Receive IT

Biospecimen Collection

Undergo blood and tissue sample collection

Craniotomy

Undergo craniotomy

Magnetic Resonance Imaging

Undergo MRI

Ommaya Reservoir Tap

Undergo Ommaya reservoir placement for collection of CSF

Primary outcome measure

  • Maximum tolerated dose (MTD) [ Time Frame: Up to 4 weeks ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Locations

Mayo Clinic in Florida

Recruiting

Jacksonville, Florida, United States, 32224-9980

Contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Principal Investigator:

Alfredo Quinones-Hinojosa, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Apr 2, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-04-02.