A Phase 2b/3a Study to Evaluate the Efficacy and Safety of JointStem in Patients Diagnosed as Knee Osteoarthritis
Status:
Recruiting
Trial end date:
2022-12-30
Target enrollment:
Participant gender:
Summary
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.