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

NCT ID: NCT03347500

Last Updated: 2017-11-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 88 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-31
• Study Completion Date: 2019-07-31

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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

use of patient-derived biological samples

Intervention Type: 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

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

use of patient-derived biological samples

Intervention Type: 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.

Interventions

use of patient-derived biological samples

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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
• suspension of NSAIDs from one week before the surgical procedure according to the standard clinical practice

Exclusion Criteria

Obese OA patients - HCV, HIV, HBV, TPHA infection

Non-obese OA patients

• HCV, HIV, HBV, TPHA infection

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

MOTEM

Identifier Type: -

Identifier Source: org_study_id