A Phase 2 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis

This is an interventional treatment trial for Osteoarthritis, Knee Read More

Inclusion Criteria:

• Subject who can give written informed consent
• Male or female of any race, aged 22-60
• Subject who had osteoarthritis of knee diagnosed at least six months prior to Screening
• Subject who has joint pain ≥ 40mm on VAS (Visual Analog Scale) at Screening
• Subject who has swelling, tenderness and active range of motion ≥ Grade I at Screening
• Subject who seeks invasive interventions of intra-articular injections
• 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 has radiographic evidence of grade 3 to 4 osteoarthritis based on the Kellgren and Lawrence radiographic criteria.
• Female subject who is neither pregnant nor lactating
• Subject who is able to comply with lifestyle guidelines, scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

• Subject who has Body Mass Index (BMI) > 35 kg/m2
• Subject who has unstable knees
• Subject who took any NSAID within two weeks from Screening
• Subject who had any intra-articular injection therapy in any joint within 2 months from Screening
• Subject who has any clinically significant disease, which is judged by the investigator to affect this clinical trial
• Subject who has inflammatory arthropathy (rheumatoid, psoriatic, or avascular necrosis), and post traumatic or septic arthritis
• Subject who has chondrocalcinosis, Paget's disease, Villonodular synovitis, and other non-OA joint diseases
• Subject who has HIV/viral hepatitis
• Subject who had knee surgery or radiation therapy in the affected joint within 6 months from Screening
• Subject who had CVA attack within 6 months from Screening
• Subject for whom the investigator judges the liposuction can cause any problem
• Subject who has significant lab abnormalities
• Subject who has history of local anesthetic allergy
• Subject who took immunosuppressants such as Cyclosporin A or azathioprine within 6 weeks from Screening
• (If a subject uses aspirin or plavix) Subject for whom it is determined that it would not be safe to stop the aspirin/plavix therapy for 2 weeks prior to Visit 2
• Subject who uses anticoagulants which cannot be stopped or corrected
• Subject who had oral or intra-muscular corticosteroids within 30 days from Visit 2
• Subject who had intra-articular corticosteroid injection in any joint within 30 days from Visit 2
• Subject who had intra-articular hyaluronic acid injection within 30 days from Visit 2
• Subject who has known hypersensitivity (allergy) to hyaluronan (sodium hyaluronate) preparations or gram positive proteins
• Subject who has knee joint infections or skin diseases or infections in the area of the injection site
• Subject who has known systemic bleeding disorders
• Subject who is an active drug/EtOH abuser
• Subject who was enrolled in any other clinical trials within 2 months from Screening
• Subject who the principal investigator considers inappropriate for the study due to any other reasons than those listed above
• Subject whose MRI scan results at screening do not demonstrate any sign of cartilage damage