Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis

Inclusion Criteria: * Male or female ≥ 21 and ≤ 80 years old at the time of screening * Willingness and ability to comply with the study procedures and visit schedules and ability to follow oral and written instructions * A standing radiograph of the knee showing a Kellgren-Lawrence grade of 2 to 4 and an absence of severe osteoarthritis * Body Mass Index ≤ 40 * A qualifying WOMAC LK 3.1 pain subscale total score * Has undergone at least one prior conservative osteoarthritis treatment * Signed an institutional review board approved informed consent 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