- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03347500
Microfluidic Organotypic Model for Monocyte Transendothelial Migration to the Joint in Obese Osteoarthritic Patients (MOTEM)
Development of a Microfluidic Organotypic Model to Evaluate Monocyte Transendothelial Migration to the Joint in Obese Osteoarthritic Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
obese OA patients
Use of patient-derived biological samples Inclusion Criteria:
Exclusion criteria: - HCV, HIV, HBV, TPHA infection |
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:
Exclusion criteria: - HCV, HIV, HBV, TPHA infection |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chemokine receptor expression
Time Frame: 24 hours
|
To evaluate and compare the expression of chemokine surface receptors on monocytes from obese and non-obese OA patients.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Monocyte transendothelial migration
Time Frame: 48 hours
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOTEM
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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