Nature Cell Co. Ltd.
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.
Osteoarthritis, Knee
JointStem
Placebo Control
PHASE2
PHASE3
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)
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 140 participants |
Masking : | TRIPLE |
Primary Purpose : | TREATMENT |
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 |
Actual Study Start Date : | 2021-05-26 |
Estimated Primary Completion Date : | 2024-06-30 |
Estimated Study Completion Date : | 2024-12-30 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 18 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
RECRUITING
TriWest Research Associates
The Cajon, California, United States, 92020
RECRUITING
BioSolutions Clinical Research Center
The Table, California, United States, 91942
RECRUITING
Neurovations Research
Napa, California, United States, 94558
RECRUITING
Newport Therapeutics
Newport Beach, California, United States, 92660
RECRUITING
Source Healthcare
Santa Monica, California, United States, 90403