A Phase 2 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: JointStem; Synvisc-One
Intervention MeSH terms: Hylan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 28.0
Sex: All
Minimum age: 22 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      This study is a double-blind, randomized, controlled study with two arms to evaluate
      JointStem as a treatment for subjects with osteoarthritis. Following a 2-week screening
      period, approximately 30 subjects will be randomly assigned into one of the following two
      arms in a 2:1 ratio (2 JointStem : 1 positive control). After each subject completes 6-month
      visit (Visit 6) and the data management team confirms all data have no issue, the individual
      database will be locked and the blinding will be open for the statistical analysis.Only
      subjects who are assigned will be requested to visit the study center for 9-month and
      12-month follow-up visits (Visits 7 and 8). To see long-term effects of JointStem, all
      subjects who complete Visit 6 will be requested to visit the study center at 24-month after
      the injection.
    

Eligibility criteria:

        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