This is an exploratory non-drug, interventional biomarker study in approximately 30 eligible patients with active osteoarthritis to investigate the degree of senescence-associated disease. Patients will provide blood and urine and undergo MRI imaging with and without gadolinium enhancement. Following imaging, arthrocentesis of both knees and an arthroscopy of the target knee will occur to obtain fluid, synovium and cartilage for analysis.
This is an exploratory non-drug, interventional, hypothesis generating biomarker study. No Investigational Product will be administered in the study, however, there are study related procedures which are interventional such as arthroscopy, arthrocentesis and infusion of a gadolinium-containing contrast agent. Consented patients who meet the selection criteria undergo MRI imaging with and without gadolinium contrast of both knees. Approximately seven days following the MRI imaging, patients undergo an arthrocentesis of both knees to obtain synovial fluid and then an arthroscopy of the target knee to obtain synovial and non-weight bearing cartilage tissues. The patient will return to the clinic approximately seven days following the arthroscopy and arthrocentesis procedures for a routine safety follow-up.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
30
Arthroscopy of the target knee
Arthrocentesis of the target knee and contralateral knee (if patient consents)
MRI with and without a gadolinium-based contrast agent
The Arthritis Treatment Center
Frederick, Maryland, United States
Degree of synovial senescence as defined by the percentage of cells staining positive for candidate molecular markers of senescence on IHC in patients with osteoarthritis
Percentage of cells staining positive for candidate molecular markers of senescence on IHC
Time frame: Study Visit 3 (Day 14)
Concentration of candidate biomarkers in serum, plasma, and urine and correlate with concentration in synovial fluid include but not limited to p16, p21, IL6
Correlation between candidate biomarkers in serum or plasma and urine with synovial fluid biomarkers
Time frame: Screening (Day 1) and Visit 3 (Day 14)
Correlation between senescence burden in synovial tissue (percentage of cells staining positive om IHC) and synovitis (semi-quantitative scoring of synovium by gadolinium-enhanced MRI)
Relationship between the synovial senescence, synovitis via biopsy samples and synovitis using gadolinium-enhanced MRI
Time frame: Visit 2 (Day 7) and Visit 3 (Day 14)
Inter-interval variability of candidate biomarkers of senescence
Inter-interval variability of candidate biomarkers of senescence
Time frame: Screening (Day 1) and Visit 3 (Day 14)
Correlation between degree of synovitis (semi-quantitative scoring of synovium by gadolinium-enhanced MRI) with concentration of biomarkers in plasma or synovial fluid
To determine the relationship between GE-MRI-based assessment of synovium and plasma or synovial candidate biomarkers
Time frame: Screening (Day 1), Visit 2 (Day 7) and Visit 3 (Day 14)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.