1. To assess the safety of allogeneic injection of expanded ADSCs to patients with knee osteoarthritis 2. To assess the efficacy of allogeneic injection of expanded ADSCs to patients with knee osteoarthritis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
57
ADSC 6.4\*10\^7 cells, allogeneic injection
Hya Joint Plus synovial fluid supplement 3mL, SciVision Biotech Inc.
ADSC 3.2\*10\^7 cells, allogeneic injection
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital Linkou
Taoyuan City, Taiwan
Changes from baseline to post-treatment visit of WOMAC pain score at week 24 after treatment
Time frame: Weeks 0, 24
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Week 48
Changes from baseline to post-treatment visits of Visual Analogue Scale (VAS) to measure Pain Levels
Time frame: Weeks 0, 2, 4, 12, 24, 36, 48
Changes from baseline to post-treatment visits of scores of sections in Knee Society Clinical Rating System (KSCRS) Score
Time frame: Weeks 0, 2, 4, 12, 24, 36, 48
Changes from baseline to post-treatment visits of MRI examination results
Time frame: Weeks 0, 24, 48, 72, 96
Changes from baseline to post-treatment visits of total score, and sub-scores of all sections in WOMAC
Time frame: Weeks 0, 2, 4, 12, 36, 48
Total acetaminophen consumption amount during the first 48 weeks and week 48 to week 96
Time frame: Week 0, 2, 4, 12, 24, 48, 96
Total non-steroidal anti-inflammatory drug (NSAID) consumption amount during the first 48 weeks and week 48 to week 96
Time frame: Weeks 0, 2, 4, 12, 24
Time to subject first time consumes acetaminophen
Time frame: Weeks 0, 2, 4, 12, 24
Time to subject first time consumes non-steroidal anti-inflammatory drug (NSAID)
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ADSC 1.6\*10\^7 cells, allogeneic injection
Time frame: Weeks 0, 2, 4, 12, 24
Number of patients with clinically abnormal laboratory values and/or adverse events that are related to treatment
Time frame: Weeks 0, 2, 4, 12, 24, 36, 48, 72, 96
Number of patients with clinically abnormal vital signs and/or adverse events that are related to treatment
Time frame: Weeks 0, 2, 4, 12, 24, 36, 48, 72, 96
Changes from baseline to week 96 visit in cartilage thickness in the total femorotibial joint by centralized (independent) imaging interpretation.
Time frame: Weeks 0, 24, 48, 72, 96