Gel-200 Versus Placebo in Osteoarthritis of the Knee

A Multi-Center, Randomized, Double-Blind, Controlled, Parallel-Group Study of a Single Intra-Articular Injection of Gel-200 With a Single Intra-Articular Injection of Phosphate Buffered Saline (PBS) in Osteoarthritis of the Knee.

The purpose of this study is to determine if a single intra-articular injection of Gel-200 is superior to a single injection of Phosphate Buffered Saline (PBS) in subjects with symptomatic osteoarthritis of the knee.

Inclusion Criteria:

• Subjects with a diagnosis of painful, symptomatic tibio-femoral osteoarthritis of the knee (Grade 1-3 on Kellgren - Lawrence (K-L) score).

Exclusion Criteria:

• Subjects with Grade 4 on K-L score
• Subjects with inflammatory diseases of the knee other than osteoarthritis such as rheumatoid arthritis
• Serious systemic diseases
• Female subjects who are pregnant or lactating