A Phase 2 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis
Status:
Completed
Trial end date:
2018-12-28
Target enrollment:
Participant gender:
Summary
This study is a double-blind, randomized, controlled study with two arms to evaluate
JointStem as a treatment for subjects with osteoarthritis. Following a 2-week screening
period, approximately 30 subjects will be randomly assigned into one of the following two
arms in a 2:1 ratio (2 JointStem : 1 positive control). After each subject completes 6-month
visit (Visit 6) and the data management team confirms all data have no issue, the individual
database will be locked and the blinding will be open for the statistical analysis.Only
subjects who are assigned will be requested to visit the study center for 9-month and
12-month follow-up visits (Visits 7 and 8). To see long-term effects of JointStem, all
subjects who complete Visit 6 will be requested to visit the study center at 24-month after
the injection.