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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS60 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Spondyloarthritis Inflammatory Bowel Diseases

Interventions

Synovial ultrasound-guided biopsy Intestinal biopsyPROCEDURE

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

Eligibility

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Viability assessment

The viability of organoids will be determined using an adenosine triphosphate (ATP) detection assay based on luminescence using a commercially available luciferase.

Time frame: 24 months

Secondary Outcomes

Production of pro-inflammatory cytokines

The production of cytokines in the culture supernatant of organoids will be evaluated using enzyme-linked immunosorbent assay (ELISA)