A Single-blind, Randomized, Parallel-group, Multi-center Phase 2 Study to Determine the Efficacy and Safety of TissueGene-C Mixed With Fibrin-glue in Patients With Degenerative Arthritis

Study start date: October 1, 2012

Inclusion Criteria: Female or male aged 18 years or more Diagnosed with degenerative arthritis of the knee With an IKDC score of 60 or lower at the screening visit With a BMI of higher than18.5 and lower than 30 With an International Cartilage Repair Society(ICRS) Grade IV cartilage damage in the major lesions, as confirmed through an MRI scan With major lesions concentrated in one section of the knee, and with the major lesions considered the main cause of the clinical symptoms With major lesions defect size 2 cm2 ~ 10cm2 With no alleviation of the symptoms even after at least three months of non-surgical treatment Healthy, with no major findings from the physical examination, hematology, serum chemistry, and urine tests, and no significant medical history Agreed to use an effective contraceptive method during the study period Voluntarily agreed to participate in this study, and signed the informed consent form Exclusion Criteria: Showed clinically significant hematology, serum chemistry, and urine test results at the screening visit Mechanical axis (HKA) is greater than 5° Patients receiving injections to the treated knee within 2 months prior to study entry Patients who are pregnant or currently breast-feeding children With another joint disease (e.g., inflammatory arthritis, infectious arthritis) With an infectious disease, including HIV or hepatitis With any of the following clinically significant diseases: heart disease [e.g., myocardial infarction, arrhythmia, other serious heart diseases, kidney disease (e.g., chronic renal failure, glomerulonephritis) liver disease (e.g., liver cirrhosis, fatty liver, acute or chronic liver disease) endocrine disease (e.g., hyperthyroidism, hypothyroidism, thyroiditis, diabetes insipidus, Cushing's disease) insulin-dependent diabetes mellitus medical history of past or current malignant tumor In particular, the tumors that TissueGene-C may aggravate can be screened using the following tests: Leukemia (White Blood Cell level in the hematology) Osteochondroma, Chondromas, Chondroblastoma, Chondromyxoid fibroma, Chondrosarcoma(Alkaline phosphatase level in the hematology) Participated in another clinical trial (using the investigational drug or a medical device) within 30 days before enrollment in this study Considered inappropriate by the investigator for participation in this study