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

NCT05789394 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: MC22070421-004561
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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; Astrocytoma, Grade IV; Recurrent Astrocytoma, IDH-Mutant, Grade 4

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD)

  Defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients). Will use the standard cohort 3+3 design.

  Up to 4 weeks

Secondary Outcomes (5)

• Incidence of adverse events (AEs)

  Up to 1 year

• Best response

  Up to 5 years

• Response rate (RR)

  Up to 5 years

• Progression free survival

  From time of AMSCs application until the first occurrence of progression or death, assessed up to 5 years

• Overall survival

  From beginning the time of AMSCs application to the date of death, assessed up to 5 years

Study Arms (1)

Treatment (AMSCs)

EXPERIMENTAL

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.

Biological: Allogeneic Adipose-derived Mesenchymal Stem Cells; Procedure: Biospecimen Collection; Procedure: Craniotomy; Procedure: Magnetic Resonance Imaging; Procedure: Ommaya Reservoir Tap

Interventions

Allogeneic Adipose-derived Mesenchymal Stem Cells BIOLOGICAL

Receive IT

Also known as: Allogeneic Adipose-derived MSCs, Allogeneic Adipose-derived Stem/Stromal Cells, Allogeneic Mesenchymal Stem/Stromal Cells

Treatment (AMSCs)

Biospecimen Collection PROCEDURE

Undergo blood and tissue sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Treatment (AMSCs)

Craniotomy PROCEDURE

Undergo craniotomy

Also known as: incision of the skull, Open Craniotomy

Treatment (AMSCs)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance, Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), MRIs, sMRI, Structural MRI

Treatment (AMSCs)

Ommaya Reservoir Tap PROCEDURE

Undergo Ommaya reservoir placement for collection of CSF

Also known as: Ommaya Reservoir Access

Treatment (AMSCs)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

You may not qualify if:

• Patients who are undergoing needle biopsy only or non-eligible for a surgical intervention
• Previous treatment with bevacizumab
• Radiographic evidence of leptomeningeal disease

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Glioblastoma; Astrocytoma

Interventions

Specimen Handling; Craniotomy; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Alfredo Quinones-Hinojosa, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: March 29, 2023
• Study Start: June 16, 2023
• Primary Completion (Estimated): July 24, 2027
• Study Completion (Estimated): July 24, 2027
• Last Updated: April 2, 2026

Record last verified: 2026-03

Locations

US (1)