Osteoarthritis, Knee Clinical Trial
Official title:
A 48-Weeks, Phase 2b/3a, Double-Blind, Randomized, Placebo Controlled, Multi-center, Superiority Study to Evaluate the Efficacy and Safety of JointStem, Autologous Adipose Tissue Derived Mesenchymal Stem Cells in Patients Diagnosed as Knee Osteoarthritis
This study is a double-blind, randomized, placebo controlled, multi-center, superiority study to evaluate the efficacy and safety of JointStem, autologous adipose tissue derived mesenchymal stem cells (AdMSC), in patients diagnosed as knee osteoarthritis. Following a 2-week screening period, approximately 140 subjects will be randomly assigned into one of the following two arms in a 1:1 ratio (1 JointStem : 1 Placebo). After each subject completes 48-Weeks visit (Visit 8) and the data management team confirms all individual data have no issue, the individual database will be locked and the blinding will be open for the statistical analysis.
Study Procedures: - Visit 1 (Week -7) - Screening - Visit 2 (Week -5) - Baseline and Randomization (Lipoaspiration) - Visit 3 (Week 0) - Treatment (Intra-articular injection) - Visit 4 (Week 4) - 4 weeks follow-up - Visit 5 (Week 12) - 12 weeks follow-up - Visit 6 (Week 24) - 24 weeks follow-up - Visit 7 (Week 36) - 36 weeks follow-up - Visit 8 (Week 48) - 48 weeks follow-up (End of Study) ;
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