Efficacy and Safety of GNSC-001 Intra-articular Injection for Knee Osteoarthritis
The goal of this clinical trial is to learn if GNSC-001 works to treat knee osteoarthritis in adults. It will also learn about the safety of GNSC-001. The main questions it aims to answer are: 1. Does GNSC-001 lower daily knee joint pain and improve function in participants? 2. What medical problems do participants have when taking GNSC-001? Researchers will compare GNSC-001 to a placebo (a look-alike substance that contains no drug) to see if GNSC-001 works to treat knee osteoarthritis. Participants will: 1. Receive a single injection of immune-modulation, and GNSC-001 or a placebo, in their knee 2. Take an oral immune-modulating pill every day for the first 22 days 3. Visit the clinic at least 9 times over 2 years for checkups and tests 4. Keep a diary of their symptoms and the number of times they use a rescue medication
OA in the target knee confirmed by radiograph and with a Kellgren-Lawrence (KL)... [+5]
Body mass index (BMI) > 38 kg/m2 [+14]