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Grafts of GSCs Into Brain Organoids for Testing Anti-invasion Drugs

Grafts of Patient-derived Glioblastoma Stem Cells Onto Autologous Brain Organoids. A Precision Medicine Model for Testing Drugs Against Tumor Invasion

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05772741
Acronym
2253
Enrollment
160
Registered
2023-03-16
Start date
2018-12-03
Completion date
2023-12-31
Last updated
2023-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glioblastoma, Glioma, Malignant

Keywords

glioma stem-like cells, brain organoids, brain invasion, ciliogenesis

Brief summary

In patients operated for glioblastoma, glioma stem-like cell lines will be obtained from tumor tissue, and IPSCs from skin fibroblasts or PBMCs. Brain organoids will be generated from IPSCs and co-cultured with IPSCs to study brain invasion and ciliogenesis. 3D genome architecture of glioma stem-like cells will be investigated. Gene modulation and pharmacologic strategies to inhibit invasion and restore ciliogenesis will be explored.

Interventions

OTHERBiological sample collection

Collection of biological samples

Sponsors

Catholic University of the Sacred Heart
CollaboratorOTHER
Istituto Superiore di Sanità
CollaboratorOTHER
Heinrich-Heine University, Duesseldorf
CollaboratorOTHER
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

o be enrolled in the study patients must: 1. Have a radiological diagnosis of supratentorial glioblastoma, or 2. Have a radiological diagnosis of first recurrence of a primary supratentorial glioblastoma (for which a formal histopathologic diagnosis of glioblastoma had made at first surgery), according with RANO criteria (Wen, 2010); 3. Be a candidate to neurosurgery for glioblastoma; 4. Be of an age of 18 years or above; 5. Provide written informed consent for participation to the study.

Exclusion criteria

To be enrolled in the study patients must not: 1. Have not enough pathological material removed at surgery available both for mandatory routine histopathological diagnosis and for the present study, as judged by the Principal Investigator; 2. Have not a definitive pathological diagnosis of a primary supratentorial glioblastoma, according with 2016 WHO classification.

Design outcomes

Primary

MeasureTime frameDescription
Invasionthrough study completion, an average of 4 yearsDistance travelled by glioma stem cells into brain organoids
Gene assessmentthrough study completion, an average of 4 yearsIdentification of genes responsible of GSC invasion, among those reportedly involved in self-renewal and ciliogenesis

Countries

Italy

Contacts

Primary ContactRoberto Pallini, MD, PhD
roberto.pallini@unicatt.it+39 06 3015 5414
Backup ContactLucia Ricci-Vitiani, PhD
lucia.riccivitiani@iss.it+39 06 49901

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026