Efficacy and Safety Study of TissueGene-C Mixed With Fibrin-glue for the Patients With Degenerative Arthritis

TissueGene-C is a biological new drug which consists of non-transduced chondrocytes and transduced chondrocytes that express TGF-b1 to regenerate the damaged cartilage.

During the clinical trial Phase 2, the investigators compare low dose or high dose TissueGene-C in 12 - months trial with 18 outpatients who have degenerative arthritis. The patients are randomized to two dose levels of TissueGene-C by 1:1 ratio, and they are monitored and recorded for alleviating symptoms, sports activities, function of the knee, and the presence of adverse events.

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