A Phase 2b/3a Study to Evaluate the Efficacy and Safety of JointStem in Patients Diagnosed as Knee Osteoarthritis

Eligibility Criteria

• * Subject who had osteoarthritis of knee diagnosed (according to the clinical and American College of Rheumatology Criteria)
• * Subject who has ≥ 34 on WOMAC function score at Screening and Baseline
• * Subject who has knee pain ≥ 70 mm for one knee out of 100 mm on VAS (Visual Analog Scale) at Screening and Baseline
• * Subject who has radiographic evidence of grade 3 osteoarthritis in the study knee based on the Kellgren and Lawrence radiographic criteria.
• * Subjects whose knee pain persists for at least 12 weeks (about 3 months) prior to screening and does not improve symptoms with non-operative treatment options
• * Subject who is willing to discontinue all pain medications for osteoarthritis except rescue medication (\< acetaminophen 3.25 g per day) at least 72 hours prior to screening and throughout the duration of study
• * Subject who is willing and able to give written informed consent for participation in the study
• * Subject who has Body Mass Index (BMI) \> 35 kg/m2
• * Subject judged by the investigator to have a history of clinically significant disease
• * Subject who has any of following clinically significant disease
• * Autoimmune diseases
• * Paget's disease, ochronosis, acromegaly, hemochromatosis, or Wilson's disease
• * Genetic diseases (hyperkinesia, collagen gene abnormality, etc.)
• * Inflammatory joint disorders (e.g. rheumatoid inflammation)
• * Infectious joint disorders (e.g. septic arthritis)
• * Other joint disorders (e.g. gout, recurrent pseudogout, articular fracture, primary osteochondrosis, villonodular synovitis)
• * Subject who has any history of cancer or currently receiving treatment for a current cancer diagnosis
• * Subject who is positive in pathogenic test (HIV, viral hepatitis, or syphilis)
• * Subject who has heart diseases (myocardial infarction, coronary artery bypass graft surgery, arrhythmia, or other serious heart diseases) or has history of heart diseases within 6 months prior to Screening
• * Subject who have received any intra-articular therapy in any joint within 6 months prior to Screening, or surgery on the relevant knee including articular endoscopic procedures within 6 months prior to Screening
• * Subject who has history of prolotherapy, or platelet rich plasma injection within 6 months prior to Screening
• * Subject who have received long-acting hyaluronic acid injection (e.g. Synvisc-One®, etc.) within 6 months prior to Screening
• * Subject who has history of stem cell therapy
• * Subject who have significant lab abnormalities for the following parameters (If the value is within 10% of the listed laboratory exclusion criterion value and the value is considered not to be clinically significant by the investigator, the subject can be considered for enrollment):
• * Serum ALT and AST \> 2 x upper limit of normal
• * Serum creatinine out of normal range
• * PT/INR out of normal range
• * Hemoglobin \< 10 g/dL for female subject and hemoglobin \< 11 g/dL for male subject
• * Platelets out of normal range
• * Subject for whom the investigator judges the lipoaspiration can cause any problem
• * Subject who has history of local anesthetic allergy
• * Subject who has taken anti-inflammatory drugs (prescription and non-prescription NSAIDs), symptomatic slow acting drugs (glucosamine, chondroitin sulfate, diacerhein etc.), or oral steroids (prednisone etc.) within 14 days prior to Screening (however, those who undergo a 14-day wash-out period can participate.)
• * Subject who is an active drug/alcohol abuser
• * Pregnant or breast-feeding women, or women or men who are not using appropriate method of contraception (appropriate method includes hormones, bilateral tubal ligation, and barrier method with spermicide, and intra-uterine device for women and vasectomy and barrier method with spermicide for men; subjects should agree to use appropriate method)
• * Subject who is enrolled in any other clinical trials within 3 months from Screening
• * Subject who received the COVID-19 vaccines within 1 week from Visit 2 (Lipoaspiration, baseline)
• * Subject who the principal investigator considers inappropriate for the study due to any other reasons than those listed above