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

Open to people ages 18 years and up

• 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