An Exploratory Clinical Study to Investigate Biomarkers of Senescence in Patients With Osteoarthritis of the Knee

Exclusion Criteria

• •1. Any condition, including laboratory findings and findings in the medical history or in the pre-study assessments, that, in the opinion of the Investigator constitutes a risk or contraindication for participation in the study or that could interfere with the study objectives, conduct or evaluation
• •2. Prior open knee surgery to the target knee including but not limited to Anterior Cruciate Ligament Repair
• •3. Patients who have had prior arthroscopy and intraarticular treatments for the management of osteoarthritis such as administration of hyaluronic acid or corticosteroids within the last 6 months
• •4. Patients with traumatic knee injury who are scheduled for arthroscopic repair procedures to either target or non-target knee
• •5. Patients who are deemed to be at risk of acute renal insufficiency of any severity due to hepato-renal syndrome or who are in the peri-operative liver transplant period.
• •6. Patients with Diabetes Mellitus.
• •7. Patients with renal dysfunction as defined by a Glomerular Filtration Rate \<60 ml/min/1.73m2 by laboratory testing.
• •8. Known allergic or hypersensitivity reaction to gadolinium-based contrast agents or patients who have other contraindications for MRI
• •9. Patients requiring anticoagulation therapy other than low dose (81 mg or less) aspirin
• •10. Treatment with an unapproved investigational therapeutic agent and/or experimental therapeutic procedure on the target knee within 24 weeks prior to screening
• •11. Any active known or suspected systemic autoimmune disease Permitted on Study
• •* vitiligo
• •* residual hypothyroidism due to autoimmune condition only requiring hormone replacement
• •* psoriasis not requiring systemic treatment for 2 years
• •* conditions not expected to recur in the absence of an external trigger Excluded on Study
• •* documented history of inflammatory bowel disease (including ulcerative colitis and Crohn's disease)
• •* symptomatic autoimmune conditions (e.g., rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\])
• •* systemic lupus erythematosus
• •* autoimmune vasculitis (e.g. Wegener's Granulomatosis)
• •* patients with motor neuropathy considered of autoimmune origin (e.g. Guillain-Barré Syndrome)
• •12. History of previous surgery (Total or Partial Knee Replacement) on the Target knee
• •13. Lesions at the planned site of arthroscopy which would present a contraindication to the procedure such as open wounds or infection of the skin
• •14. Any known active infection, including suspicion of intra-articular infection and/or infections that may compromise the immune system such as HIV, Hepatitis B or Hepatitis C infection
• •15. History of sarcoma and/or history of other active malignancy within the last 5 years, except basal cell carcinoma, carcinoma in situ of the cervix and squamous cell carcinoma of the skin
• •16. Secondary osteoarthritis, including:
• •* Joint dysplasias
• •* Crystal-induced arthropathy (gout, calcium pyrophosphate deposition disease)
• •* Aseptic osteonecrosis
• •* Acromegaly
• •* Paget's disease
• •* Ehlers-Danlos Syndrome
• •* Gaucher's disease
• •* Stickler's syndrome
• •* Joint infection
• •* Hemophilia
• •* Hemochromatosis
• •* Neuropathic arthropathy of any cause
• •17. Patients with risk factors for OA of the knee (e.g.: obesity, meniscectomy) are not considered as having secondary OA and can be included in this study
• •18. Female patients who are pregnant. Female patients who are breast-feeding are eligible for enrollment providing the patient agrees not to breast-feed for 24 hours after receiving gadolinium for GE-MRI. Female patients of child-bearing potential must agree to utilize adequate contraceptive measures during the course of the study.
• •19. Patients who do not have the legal capacity or medical competency to provide consent; consent via legally authorized representative is not accepted.