A Phase 2b/3a Study to Evaluate the Efficacy and Safety of JointStem in Patients Diagnosed as Knee Osteoarthritis

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)

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.

A Phase 2b/3a Study to Evaluate the Efficacy and Safety of JointStem in Patients Diagnosed as Knee Osteoarthritis

Recruitment

Summary

Participation Requirements

Description

Tracking Information