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NCT05789394 · ClinicalTrials.gov registry record · Phase 1
Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Recurrent Glioblastoma or Recurrent Astrocytoma in Patients Undergoing Craniotomy
A Phase 1 study of Astrocytoma, Grade IV and Recurrent Glioblastoma, IDH-Wildtype, sponsored by Mayo Clinic.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT05789394 is a Phase 1 study of Astrocytoma, Grade IV and Recurrent Glioblastoma, IDH-Wildtype that is actively recruiting participants, run by Mayo Clinic. The registered enrollment target is 20 participants, below the 305-participant average among 4 other Astrocytoma, Grade IV trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05789394, a Phase 1 study of Astrocytoma, Grade IV and Recurrent Glioblastoma, IDH-Wildtype, is actively recruiting participants, sponsored by Mayo Clinic.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Magnetic Resonance Imaging
- BIOLOGICAL Allogeneic Adipose-derived Mesenchymal Stem Cells
- PROCEDURE Craniotomy
- PROCEDURE Ommaya Reservoir Tap
Study Locations (1)
Florida
- Mayo Clinic in Florida - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2023-06-16 |
| Est. Completion | 2026-07-24 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05789394
The ClinicalTrials.gov registry entry for NCT05789394 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 305-participant average among 4 other Astrocytoma, Grade IV trials with a reported enrollment target (93% lower). The listed sponsor is Mayo Clinic, which has 2,844 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Astrocytoma, Grade IV appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05789394 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT05789394 about?
NCT05789394 is a clinical study titled "Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Recurrent Glioblastoma or Recurrent Astrocytoma in Patients Undergoing Craniotomy". 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 ag...
What is the current status of trial NCT05789394?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2023-06-16. Estimated completion is 2026-07-24.
What conditions does trial NCT05789394 study?
This clinical trial studies the following conditions: Astrocytoma, Grade IV, Recurrent Glioblastoma, IDH-Wildtype, Recurrent Astrocytoma, IDH-Mutant, Grade 4.
What interventions are being tested in trial NCT05789394?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Magnetic Resonance Imaging (PROCEDURE), Allogeneic Adipose-derived Mesenchymal Stem Cells (BIOLOGICAL), Craniotomy (PROCEDURE), Ommaya Reservoir Tap (PROCEDURE).
Who is sponsoring clinical trial NCT05789394?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05789394 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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