2ccPA Study in Patients With Symptomatic Knee Osteoarthritis

Exclusion Criteria

• •1. Subjects with known hypersensitivity to study medication
• •2. Female subjects who are pregnant or lactating. Women of childbearing potential must agree to practice medically acceptable contraceptive regimen from screening visit until at least 1 month after the study treatment and must have a negative urine pregnancy test no earlier than 72 hours prior to study treatment.
• •3. Intra-articular use of corticosteroid, hyaluronic acid or other intra-articular injection in study knee within 3 months prior to study entry (randomization)
• •4. Use of chondroitin and/ or glucosamine within 4 weeks prior to study entry (randomization)
• •5. Subjects with known malignancy
• •6. History of Reiter's syndrome, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, lymphoma, arthritis associated with inflammatory bowel disease, sarcoidosis and amyloidosis
• •7. Prior arthroscopic or open surgery on the study knee within 6 months prior to study entry (randomization)
• •8. Clinical signs and symptoms of active knee infection or being treated for knee infection at screening
• •9. Patients with active inflammation: patients with CRP higher than upper limit of normal range at screening visit will be excluded from the study.
• •10. Subjects with concurrent medical or arthritic condition that could interfere with evaluation of the index knee joint, including fibromyalgia, based on investigator's clinical judgment
• •11. More significant pain from the back or the hip than the knee
• •12. Skin breakdown or lesion on the study knee that is not suitable for injection, based on investigator's discretion
• •13. Prior knee replacement on the study knee or planned knee replacement during the study period
• •14. Subjects with (1) meniscus tears which requires repairment surgery OR (2) anterior cruciate ligament rupture based on screening MRI results
• •15. Patients with known severe synovitis, synovium necrosis in the target knee joint judged by investigator at screening
• •16. Patients with PT/ APTT higher than the upper limit of normal range at screening
• •17. History of drug or alcohol dependence in the past 3 years
• •18. Having known infection with HIV-1, HBV, HCV
• •19. Use of any investigational drug or participation in any drug study within 4 weeks prior to study entry (randomization)
• •20. Subjects who are unwilling or unable to comply with study procedures
• •21. Any clinical condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk to participate in the study or confounds the ability to interpret data from the study as judged by the investigator.