Adaptive and Trained Immunity in the Pathogenesis of IgG4-Related Disease

N/AActive Not RecruitingNCT06844864

IRCCS San Raffaele20 enrolled

Overview

Enquire involvement of trained immunity in the pathogenesis of IgG4RD

Enquire involvement of trained immunity in the pathogenesis of IgG4RD using primary macrophages and co-cultures with patient derived fibroblasts. The investigators will first assess whether macrophages from patients are trained compared to macrophages of healthy controls and then challenge them with IgG from IgG4RD patients to evaluate the functional effects on cultivated fibroblasts.

Study Type

OBSERVATIONAL

Enrollment

Conditions

IgG4 Related Disease

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Patients: * Adult subjects \> or = 18 years of age * Subjects capable of providing informed consent * Active IgG4-RD based on the IgG4-related disease activity index * Fulfillment of the 2019 ACR/EULAR Classification Criteria for IgG4RD Healthy Controls: * Adult subjects \> or = 18 years of age * Subjects capable of providing informed consent Exclusion Criteria: Patients and healthy controls: * Subjects \< 18 years of age * Pregnant women * Comorbidities (other ongoing active autoimmune diseases, ongoing cancer, ongoing infections) * Ongoing immunosuppressive therapy

Locations (1)

Ospedale San Raffaele

Milan, MI, Italy

Outcomes

Primary Outcomes

Concentration of collagen Ia in the supernant of macrophage/fibroblast co-cultures

Concentration of collagen Ia (ng/uL) in the supernant of macrophage/fibroblast co-cultures through ELISA assay

Time frame: 7 months

Data from ClinicalTrials.gov

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