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

Part of paid clinical trials in Jacksonville, Florida.

Sponsor
Mayo Clinic
Study ID
NCT05789394
Phase
PHASE1
Status
Recruiting
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Conditions

  • Astrocytoma, Grade IV
  • Recurrent Astrocytoma, IDH-Mutant, Grade 4
  • Recurrent Glioblastoma, IDH-Wildtype

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Allogeneic Adipose-derived Mesenchymal Stem Cells — BIOLOGICAL
    Receive IT
  • Biospecimen Collection — PROCEDURE
    Undergo blood and tissue sample collection
  • Craniotomy — PROCEDURE
    Undergo craniotomy
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Ommaya Reservoir Tap — PROCEDURE
    Undergo Ommaya reservoir placement for collection of CSF

Study Details

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 Dates

Start date
Jun 16, 2023
Status verified
Mar 2026
Primary completion
Jul 24, 2027
Completion
Jul 24, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in FloridaJacksonvilleFlorida32224-9980
Clinical Trials Referral Office
[email protected]
855-776-0015
Alfredo Quinones-Hinojosa, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Mayo Clinic in Florida· Jacksonville, FL

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