Microfluidic Organotypic Model for Monocyte Transendothelial Migration to the Joint in Obese Osteoarthritic Patients

NCT03347500 | Unknown

• 1 other identifier: MOTEM
• Study Type: observational
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief Summary

Osteoarthritis (OA) is the fastest growing cause of disability worldwide due to population ageing and increasing obesity incidence. Obese individuals have a higher risk of OA insurgence and severe progression due to several risk factors, including their systemic inflammation state and superior migratory ability of monocytes. In the present project we aim at the development of a novel 3D microfluidic organotypic model resembling the joint to investigate the migration ability of monocytes from obese and non-obese OA patients. We hypothesize that monocytes from obese OA patients display superior migration ability and a specific pattern of chemokine surface receptors compared to monocytes from non-obese OA patients. We also hypothesize that these features lead to a superior infiltration of monocytes/macrophages to the synovial membrane in obese OA patients. Based on this, our main aim will be to highlight differences between Mo from obese and non-obese OA patients in terms of surface receptors and migration ability in a microfluidic organotypic model.

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• Chemokine receptor expression

  To evaluate and compare the expression of chemokine surface receptors on monocytes from obese and non-obese OA patients.

  24 hours

Secondary Outcomes (1)

• Monocyte transendothelial migration

  48 hours

Study Arms (2)

obese OA patients

Use of patient-derived biological samples Inclusion Criteria: * Subscription of informed consent * BMI ≥ 30 * age between 60-80 years included * Kelgrenn-Lawrence equal or superior to grade III * presence of synovitis * patients undergoing knee replacement * suspension of NSAIDs from one week before the surgical procedure according to the standard clinical practice Exclusion criteria: \- HCV, HIV, HBV, TPHA infection

Other: use of patient-derived biological samples

Non-obese OA patients

Use of patient-derived biological samples Inclusion criteria: * Subscription of informed consent * BMI ≤ 28 * age between 60-80 years included * Kelgrenn-Lawrence equal or superior to grade III * presence of synovitis * patients undergoing knee replacement * suspension of NSAIDs from one week before the surgical procedure according to the standard clinical practice Exclusion criteria: \- HCV, HIV, HBV, TPHA infection

Other: use of patient-derived biological samples

Interventions

use of patient-derived biological samples OTHER

We will use biological samples that are routinely collected as waste material from patients undergoing prosthetic surgery at IRCCS Istituto Ortopedico Galeazzi. Peripheral blood will be also collected from patients during the pre-surgery visit and during the post-surgery hospitalization coinciding with routine blood sample collection.

Non-obese OA patients; obese OA patients

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

OA patients undergoing prosthetic surgery at IRCCS Istituto Ortopedico Galeazzi

You may qualify if:

• Obese OA patients
• Subscription of informed consent
• BMI ≥ 30
• age between 60-80 years included
• Kelgrenn-Lawrence equal or superior to grade III
• presence of synovitis
• patients undergoing knee replacement
• suspension of NSAIDs from one week before the surgical procedure according to the standard clinical practice
• Non-obese OA patients
• Subscription of informed consent
• BMI ≤ 28
• age between 60-80 years included
• Kelgrenn-Lawrence equal or superior to grade III
• presence of synovitis
• patients undergoing knee replacement

You may not qualify if:

• Obese OA patients - HCV, HIV, HBV, TPHA infection
• Non-obese OA patients
• \- HCV, HIV, HBV, TPHA infection

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 20, 2017
• Study Start: December 1, 2017
• Primary Completion: December 1, 2018
• Study Completion: July 1, 2019
• Last Updated: November 20, 2017

Record last verified: 2017-11