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

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