Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis

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

During the clinical trial Phase 2A, we compare low dose or high dose TissueGene-C in 6 months trial with 28 outpatients who have degenerative arthritis. The patients are randomized to two dose levels of TisssueGene-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

• Male or female, aged 45 years or more
• With grade 4 degenerative arthritis of the knee [based on the International Cartilage Repair Society(ICRS) evaluation criteria from the MRI results]
• With less than 6 cm2major lesions
• With major lesions (grade 4) concentrated in only one section of the knee and considered the main cause of the clinical symptoms
• Unresponsive to conventional symptomatic treatment
• Healthy and with no major physical examination, hematology, serum chemistry, and urine test findings 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

• Abnormal screening laboratory test (hematology, serum, and urine test) findings
• Took anti-inflammatory medications (prescribed or over-the-counter), including natural medicines, within 14 days before the injection of the investigational product
• Took antirheumatic drugs (e.g., methotrexate or antimetabolites) within three months before enrollment in this study
• Has a history of drug abuse within one year from the enrolment, or has positive results in the urine drug test or serum alcohol test at the screening visit
• Received an injection in the target knee within two months before enrollment in this study
• Pregnant or breastfeeding female
• With another joint disease apart from degenerative arthritis (e.g., systemic rheumatic inflammatory disease associated with the knee or chondrocalcinosis, hemachromatosis, inflammatory arthritis, necrosis of the trochanter, Paget's disease adjacent to a joint in the femur or tibia, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's disease in the knee joint, villonodular synovitis, and synovial chondromas)
• With a current infectious disease, including HIV or hepatitis
• Has any of the following clinically significant diseases:

• heart disease [e.g., myocardial infarction, arrhythmia, other serious heart disease, coronary artery bypass graft (CABG)]
• 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 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 by the investigator inappropriate for participation in this study