Saline-Controlled Study of nSTRIDE APS for Knee Osteoarthritis

A Multicenter, Double-Blind, Randomized, Saline-Controlled Study of a Single, Intra-articular Injection of Autologous Protein Solution in Patients With Knee Osteoarthritis

A double-blind, multicenter, randomized, controlled trial (RCT) that will evaluate the efficacy of a single dose of Autologous Protein Solution (APS) in patients with Osteoarthritis (OA) of the knee.

A double-blind, multicenter, randomized, saline-controlled trial (RCT) that will evaluate the efficacy of a single dose of Autologous Protein Solution (APS) in patients with symptomatic osteoarthritis (OA) of the knee who have not been able to get satisfactory pain relief with prior treatment.

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