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
Nature Cell Co. Ltd.
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.
Description
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)
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
\<Inclusion Criteria\> 1. Male or female of any race, adult aged 18 years or older 2. Subject who had osteoarthritis of knee diagnosed (according to the clinical and American College of Rheumatology Criteria) 3. Subject who has ≥ 45 on WOMAC function score at Screening and Baseline 4. Subject who has knee pain ≥ 70 mm for the study knee out of 100 mm on VAS (Visual Analog Scale) at Screening and Baseline 5. Subject who has radiographic evidence of grade 3 osteoarthritis in the study knee based on the Kellgren and Lawrence radiographic criteria 6. Subject who has a varus angle of 5 degrees or…
Interventions
- DrugJointStem
Autologous Adipose tissue derived Mesenchymal Stem Cells (AdMSC)
- OtherPlacebo Control
Normal Saline with autologous Serum
Locations (9)
- TriWest Research AssociatesEl Cajon, California
- BioSolutions Clinical Research CenterLa Mesa, California
- Neurovations ResearchNapa, California
- Newport TherapeuticsNewport Beach, California
- Source HealthcareSanta Monica, California
- Keimyung University Dongsan HospitalDaegu, Korea