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

Osteoarthritis Clinical Trial

— MOTEM  

Official title:

Development of a Microfluidic Organotypic Model to Evaluate Monocyte Transendothelial Migration to the Joint in Obese Osteoarthritic Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03347500
• Other study ID #: MOTEM
• Status: Not yet recruiting
• Phase: N/A
• First received: November 15, 2017
• Last updated: November 15, 2017
• Start date: December 2017
• Est. completion date: July 2019

Study information

• Verified date: November 2017
• Source: Istituto Ortopedico Galeazzi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: July 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Other:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Ortopedico Galeazzi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Monocyte transendothelial migration	To monitor the transendothelial migration of monocytes from OA patients in response to chemokines present in the synovial fluid using a microfluidic organotypic model.	48 hours