A Randomized Double-Blind Placebo-Controlled Multi-Center Phase 3 Study to Determine the Efficacy and Safety of TG-C in Subjects with Kellgren and Lawrence Grade 2 or 3 Osteoarthritis of the Knee

Brief description of study

The purpose of this clinical research study is to investigate the safety and efficacy (how well something works) of a drug named TG-C to treat osteoarthritis (degenerative joint disease). “Investigational new drug” means that it is a drug that has not been approved for marketing by the United States (US) Food and Drug Administration (FDA), except for use in research studies. The FDA is allowing TG-C to be used in this research study. This clinical research study is being sponsored by Kolon TissueGene, Inc. (hereafter referred to as the Sponsor). Osteoarthritis is a joint disease that causes an inflammatory response (the body’s response to disease or injury such as redness, swelling, warmth, and pain), which worsens over time. Osteoarthritis is a serious condition that can affect the different parts of the joint including cartilage, bone, synovium (membrane that covers the joint and releases fluid), ligaments (connects bones to each other), and meniscus (cartilage between joints). Cartilage is a thin covering on surface of joints that acts as a cushion, which protects your bones and helps your joints to move smoothly.

Clinical Study Identifier: s21-00761
ClinicalTrials.gov Identifier: NCT03291470

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