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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
173
Autologous Adipose tissue derived Mesenchymal Stem Cells (AdMSC)
Normal Saline with autologous Serum
TriWest Research Associates
El Cajon, California, United States
BioSolutions Clinical Research Center
La Mesa, California, United States
Neurovations Research
Napa, California, United States
Newport Therapeutics
Newport Beach, California, United States
Source Healthcare
Santa Monica, California, United States
Keimyung University Dongsan Hospital
Daegu, Korea, South Korea
Kyung Hee University Medical Center
Seoul, Korea, South Korea
Kyung Hee University Hospital At Gangdong
Seoul, Korea, South Korea
Smg-Snu Boramae Medical Center
Seoul, Korea, South Korea
Western Ontario and McMaster Universities Arthritis Index (WOMAC) function Score
Change from baseline in WOMAC function score at Week 48
Time frame: Baseline and Week 48
Visual Analog Scale (VAS) score
Change from baseline on Visual Analog Scale (VAS) score at Week 48
Time frame: Baseline and Week 48
Western Ontario and McMaster Universities Arthritis Index (WOMAC) subscale (Function)
Change from baseline in WOMAC subscale (Function) score at Week 12, 24, and 36
Time frame: Week 12, 24 and 36
Western Ontario and McMaster Universities Arthritis Index (WOMAC) subscale (Pain)
Change from baseline in WOMAC subscale (Pain) score at Week 12, 24, 36, and 48
Time frame: Week 12, 24, 36, and 48
Total Western Ontario and McMaster Universities Arthritis Index (WOMAC) score
Change from baseline in total WOMAC score at Week 12, 24, 36, and 48
Time frame: Week 12, 24, 36, and 48
Visual Analog Scale (VAS) score
Change from baseline in VAS score at Week 12, 24 and 36
Time frame: Week 12, 24 and 36
International Knee Documentation Committee (IKDC) score
Change from baseline in IKDC score at Week 12, 24, 36, and 48
Time frame: Week 12, 24, 36, and 48
36-Item Short Form health survey questionnaires (SF-36) score
Change from baseline in SF-36 score at Week 12, 24, 36, and 48
Time frame: Week12, 24, 36, and 48
Kellgren-Lawrence grade
Change from screening in Kellgren-Lawrence grade of knee osteoarthritis determined by X-ray at Week 48
Time frame: Week 48
Number and amount of rescue medication use
The number and amount of rescue medication use at Week 12, 24, 36, and 48
Time frame: Week 12, 24, 36, and 48
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