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New treatment option for Recurrent Glioblastoma, IDH-Wildtype
Official title Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Recurrent Glioblastoma or Recurrent Astrocytoma in Patients Undergoing Craniotomy
ClinicalTrials.gov ID: NCT05789394
What this study is testing
What is Allogeneic Adipose-derived Mesenchymal Stem Cells?
Allogeneic Adipose-derived Mesenchymal Stem Cells is an investigational medicine, being studied as a potential treatment for recurrent glioblastoma, idh-wildtype.
Also referred to as Allogeneic Adipose-derived MSCs, Allogeneic Adipose-derived Stem/Stromal Cells.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- There is measurable disease according to the immunotherapy response assessment in neuro-oncology (iRANO) criteria
You likely can't join if
- 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
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Jacksonville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jacksonville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.