MedTrace Logo

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

NCT05789394 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-02

No results posted yet for this study

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

Interventions

BIOLOGICAL

Allogeneic Adipose-derived Mesenchymal Stem Cells

Receive IT

PROCEDURE

Biospecimen Collection

Undergo blood and tissue sample collection

PROCEDURE

Craniotomy

Undergo craniotomy

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Ommaya Reservoir Tap

Undergo Ommaya reservoir placement for collection of CSF

Sponsors & Collaborators

Principal Investigators

  • Alfredo Quinones-Hinojosa, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-16
Primary Completion
2027-07-24
Completion
2027-07-24
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05789394 on ClinicalTrials.gov