Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis

Exclusion Criteria

• •Presence of clinically observed active infection in the index knee
• •Presence of symptomatic osteoarthritis in the non-study knee
• •Diagnosed with rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis, or arthritis secondary to other inflammatory diseases; HIV, viral hepatitis; chondrocalcinosis, Paget's disease, or villonodular synovitis
• •Diagnosed with leukemia, known presence of metastatic malignant cells, or ongoing or planned chemotherapeutic treatment
• •Untreated symptomatic injury of the index knee
• •Presence of surgical hardware or other foreign body intended to treat arthritis or cartilage-related pathology in the index knee
• •Previous cartilage repair procedure on the injured cartilage surface of the index knee
• •Arthroplasty or open surgery of the index knee within 6 months of screening
• •Intra-articular steroid injection in the index knee within 3 months of screening
• •Intra-articular hyaluronic acid injection in the index knee within 6 months of screening
• •Other intra-articular therapy in the index knee within 6 months prior to screening
• •Orally administered systemic steroid use within 2 weeks of screening
• •Planned/anticipated surgery of the index knee during the study period
• •Skin breakdown at the knee where the injection is planned to take place
• •Pregnant or nursing mothers or women planning on getting pregnant during the time they will be participating in the study
• •Participated in any investigational drug or device trial within 30 days prior to screening
• •Participated in any investigational biologic trial within 60 days prior to screening