RecruitingPhase 1NCT05789394

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

Phase 1, Dose Escalation, Non-Randomized, Open Label, Clinical Trial Evaluating the Safety and Preliminary Efficacy of Allogenic Adipose-Derived Mesenchymal Stem Cells (AMSCs) for Recurrent Glioblastoma


Sponsor

Mayo Clinic

Enrollment

20 participants

Start Date

Jun 16, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether stem cells derived from fat tissue — called allogeneic adipose-derived mesenchymal stem cells — can help treat glioblastoma or high-grade astrocytoma that has come back after initial treatment. These patients are undergoing repeat brain surgery, and stem cells will be delivered directly into the tumor site. **You may be eligible if...** - You are 18 or older - You have been previously diagnosed with glioblastoma (IDH wildtype) or high-grade astrocytoma (IDH-mutant, WHO grade IV) - Your tumor has grown back and your surgeon believes you are a candidate for repeat brain surgery - Your functional status is reasonably good (KPS ≥ 60) - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You are pregnant - Your tumor has not shown measurable regrowth - Your liver, kidney, or clotting function is significantly impaired - You are not a suitable candidate for surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALAllogeneic Adipose-derived Mesenchymal Stem Cells

Receive IT

PROCEDUREBiospecimen Collection

Undergo blood and tissue sample collection

PROCEDURECraniotomy

Undergo craniotomy

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

PROCEDUREOmmaya Reservoir Tap

Undergo Ommaya reservoir placement for collection of CSF


Locations(1)

Mayo Clinic in Florida

Jacksonville, Florida, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05789394


Related Trials