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Validation of a Preclinical Model Based on Patient-derived Organoids for the Study of the Gut-joint Axis in Spondyloarthritis

Validation of a Preclinical Model Based on Patient-derived Organoids for the Study of the Gut-joint Axis in Spondyloarthritis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06421116
Acronym
ORGANOSPA
Enrollment
60
Registered
2024-05-20
Start date
2024-03-07
Completion date
2025-12-31
Last updated
2024-05-20

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

Conditions

Inflammatory Bowel Diseases, Spondyloarthritis

Brief summary

This project aims to develop and validate a model of human organoids derived from patients with Spondyloarthritis, focusing on synovial and intestinal tissues as targets of the gut-joint axis. The tissue marker profile of patient-derived organoids studied by gene expression, immunohistochemistry, and cytokine production profile will be compared with that of controls in order to test for the presence of specific biomarkers.

Interventions

PROCEDURESynovial ultrasound-guided biopsy Intestinal biopsy

Patients will undergo biopsies if needed for standard-of-care follow-up and after clinical indication.

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* More than 18 years of age; * Ability to understand and sign an informed consent form; * Clinical indication for intestinal and/or synovial biopsy; * Only for SpA patients group: meeting ASAS classification criteria.

Exclusion criteria

* Actively treated cancer; * Severe comorbidities that, in the investigator's opinion, may affect the quality of samples for planned experimental applications; * Only for patients undergoing ileal-colic biopsy: history of colorectal cancer disease, celiac disease; * Only for patients undergoing a synovial biopsy: septic arthritis.

Design outcomes

Primary

MeasureTime frameDescription
Viability assessment24 monthsThe viability of organoids will be determined using an adenosine triphosphate (ATP) detection assay based on luminescence using a commercially available luciferase.

Secondary

MeasureTime frameDescription
Production of pro-inflammatory cytokines24 monthsThe production of cytokines in the culture supernatant of organoids will be evaluated using enzyme-linked immunosorbent assay (ELISA)

Other

MeasureTime frameDescription
Invasion capacity assessment (synovial organoids)24 monthsFibroblast-like synoviocytes (FLS) will be dispensed into a well of a Fluorobook invasion plate. The fluorescence will be measured as an index of FLS invasion capacity in the presence of a basement membrane extract.

Countries

Italy

Contacts

Primary ContactMaria Antonietta D'Agostino, Professor
mariaantoniettadagostino@policlinicogemelli.it+390630157807
Backup ContactGerlando Natalello, Dr
gerlando.natalello1@guest.policlinicogemelli.it+390630157807

Outcome results

None listed

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