Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-28 @ 12:15 AM
Study NCT ID:
NCT05789394
Status:
RECRUITING
Last Update Posted:
2025-10-27
First Post:
2023-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Recurrent Glioblastoma or Recurrent Astrocytoma in Patients Undergoing Craniotomy
Sponsor:
Mayo Clinic
Organization:
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
PRIMARY OBJECTIVE:
I. To establish the maximum tolerated dose (MTD) of locally delivered adipose-derived mesenchymal stem cells (AMSCs) in patients with recurrent glioblastoma (GBM).
SECONDARY OBJECTIVES:
I. To assess the safety and toxicity profile of locally delivered AMSCs in patients with recurrent GBM.
II. To assess overall survival (OS) in recurrent GBM patients treated with locally delivered AMSCs.
III. To assess progression free survival (PFS) in recurrent GBM patients treated with locally delivered AMSCs.
CORRELATIVE OBJECTIVES:
I. To explore the systemic immune response after application of AMSCs through cytokine analysis on peripheral blood samples.
II. To explore the local changes on the brain parenchyma by analyzing tissue at recurrence.
III. To explore the presence of AMSCs on brain tissue at recurrence.
OUTLINE: This is a dose-escalation study.
Patients receive AMSCs intratumorally (IT) and undergo Ommaya reservoir placement during a craniotomy on study. Patients also undergo magnetic resonance imaging (MRI) on study and during follow-up, as well as blood sample, tissue sample and cerebrospinal fluid (CSF) sample collection on study.
After completion of study treatment patients are followed up every 2 months for 1 year.
I. To establish the maximum tolerated dose (MTD) of locally delivered adipose-derived mesenchymal stem cells (AMSCs) in patients with recurrent glioblastoma (GBM).
SECONDARY OBJECTIVES:
I. To assess the safety and toxicity profile of locally delivered AMSCs in patients with recurrent GBM.
II. To assess overall survival (OS) in recurrent GBM patients treated with locally delivered AMSCs.
III. To assess progression free survival (PFS) in recurrent GBM patients treated with locally delivered AMSCs.
CORRELATIVE OBJECTIVES:
I. To explore the systemic immune response after application of AMSCs through cytokine analysis on peripheral blood samples.
II. To explore the local changes on the brain parenchyma by analyzing tissue at recurrence.
III. To explore the presence of AMSCs on brain tissue at recurrence.
OUTLINE: This is a dose-escalation study.
Patients receive AMSCs intratumorally (IT) and undergo Ommaya reservoir placement during a craniotomy on study. Patients also undergo magnetic resonance imaging (MRI) on study and during follow-up, as well as blood sample, tissue sample and cerebrospinal fluid (CSF) sample collection on study.
After completion of study treatment patients are followed up every 2 months for 1 year.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: