Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Astrocytoma, Grade IV | Astrocytoma | CURATED_BROADER | 0.80 |
| Recurrent Astrocytoma, IDH-Mutant, Grade 4 | Astrocytoma, IDH-Mutant, Grade 4 | CURATED_BROADER | 0.78 |
| Recurrent Glioblastoma, IDH-Wildtype | Glioblastoma, IDH-Wildtype | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Allogeneic Adipose-derived Mesenchymal Stem Cells | Biological | — | UNRESOLVED |
| Biospecimen Collection | Procedure | — | UNRESOLVED |
| Craniotomy | Procedure | — | UNRESOLVED |
| Magnetic Resonance Imaging | Procedure | — | UNRESOLVED |
| Ommaya Reservoir Tap | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (AMSCs)
- description
- 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.
- interventionNames
- Biological: Allogeneic Adipose-derived Mesenchymal Stem Cells
- Procedure: Biospecimen Collection
- Procedure: Craniotomy
- Procedure: Magnetic Resonance Imaging
- Procedure: Ommaya Reservoir Tap
Primary outcomes (1)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- Up to 4 weeks
- description
- Defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least one-third of patients (at least 2 of a maximum of 6 new patients). Will use the standard cohort 3+3 design.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants \>= 18 years * Karnofsky Performance Scale (KPS) \>= 60 * Negative pregnancy test done =\< 7 days prior to registration, for persons of childbearing potential only * Patients with a previous histological diagnosis of glioblastoma multiforme, isocitrate dehydrogenase (IDH) wildtype (WT) or astrocytoma, IDH-mutant World Health Organization (WHO) grade IV according to the 2021 WHO classification of tumors of the central nervous system , who are candidates to- and will undergo a redo craniotomy for excision of recurrent tumor * There is measurable disease according to the immunotherapy response assessment in neuro-oncology (iRANO) criteria * Serum creatinine and urea \<= 2 times the upper limit of normal (=\< 3 weeks prior to registration) * Alanine transaminase (ALT), aspartate transferase (AST) and alkaline phosphatase =\< 3 times the upper limit of normal, and bilirubin =\< 2.5 mg/dL (=\< 3 weeks prior to registration) * Prothrombin time =\< 1.5 times upper limit of normal (=\< 3 weeks prior to registration) * International normalized ratio (INR) and partial thromboplastin time (PTT) =\< 1.5 times the upper limit of normal (=\< 3 weeks prior to registration) * Hemoglobin \>= 9 g/dL (=\< 3 weeks prior to registration) * Platelets \>= 100 x 10\^9/L (=\< 3 weeks prior to registration) * Absolute neutrophil count (ANC) \>= 1.5 x 10\^9/L (=\< 3 weeks prior to registration) * Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) * Patient or legally authorized representative (LAR) is able to fully understand and provide written and verbal consent for the protocol * Willingness to provide mandatory blood specimens for correlative research * Willingness to provide mandatory tissue specimens for correlative research * Willingness to undergo Ommaya reservoir placement and provide cerebrospinal fluid (CSF) samples for correlative research Exclusion Criteria: * Patients who are undergoing needle biopsy only or non-eligible for a surgical intervention * Tumors located solely in the brain stem, midbrain, or thalamus without inclusion/involvement of surrounding brain matter * Previous treatment with bevacizumab * Radiographic evidence of leptomeningeal disease
References
Publications (0)
Data not yet available