A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Clinical Study to Evaluate the Efficacy and Safety of IxCell hUC-MSC-O in Patients With Knee Osteoarthritis
To evaluate the efficacy of IxCell hUC-MSC-O in the treatment of patients with knee osteoarthritis. To evaluate the safety of IxCell hUC-MSC-O in the treatment of patients with knee osteoarthritis.
• Patients diagnosed with knee osteoarthritis according to the Guidelines for the Diagnosis and Treatment of Osteoarthritis (2018 Edition) by the Joint Surgery Group of the Orthopedics Branch of the Chinese Medical Association;
• Patients with persistent pain for more than half a year, or those whose knee osteoarthritis recurs or worsens after discontinuing conventional clinical treatments such as hormones, opioids, non-steroidal anti-inflammatory drugs, viscosupplementary therapy, etc.;
• The study side knee joint Kellgren-Lawrence grade is II～III, and the other side knee Kellgren-Lawrence is ≤II;
• Patients with a total WOMAC score of ≥50 and ≤150 at the time of screening;
• Patients with a VAS pain score of ≥50mm (total score of 100mm) in the study side knee joint at the time of screening;
• Ages between 40 and 80, with no gender restrictions. BMI (Body Mass Index, weight \[kg\]/height\^2 \[m\^2\]) ≤30;
• Able to understand and voluntarily sign the informed consent form, and willing to complete the trial procedures and follow-up examinations.