NCT05789394Toboroz1. fázis
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. ápr. 2.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 1. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 20 (tervezett)
- Első benyújtás
- 2023. márc. 16.
- Kezdés
- 2023. jún. 16.
- Elsődleges befejezés
- 2027. júl. 24.
- Fő szponzor
- Mayo Clinic
- Betegségek
- Glioblasztóma
- NCT-szám
- NCT05789394
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 1. fázis
- Tervezett résztvevők: 20
- 2023. jún. 16. és az elsődleges befejezés (2027. júl. 24.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Korábbi kezelés
- Patients who are undergoing needle biopsy only or non-eligible for a surgical intervention
- Previous treatment with bevacizumab
Más betegség
- Radiographic evidence of leptomeningeal disease
Egyéb
- Tumors located solely in the brain stem, midbrain, or thalamus without inclusion/involvement of surrounding brain matter
Kiket keres a vizsgálat
- 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
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Mayo Clinic in Florida | Jacksonville | Egyesült Államok | Toboroz |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.