The purpose of this study is to determine whether TissueGene-C, allogeneic human chondrocytes expressing Transforming Growth Factor(TGF)-b1, mixed with fibrin-glue is effective and safe in 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
18
TissueGene-C at 1.0 x 10\^6 cells mixed with fibrin-glue
TissueGene-C at 3.0 x 10\^6 cells mixed with fibrin-glue
Kyungpook National University Hospital
Daegu, South Korea
Inha University Hospital
Incheon, South Korea
Seoul National University Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Changes in IKDC Subjective Knee Evaluation
Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)
Time frame: Week 0 and 48
Changes in WOMAC scores
Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC)
Time frame: Week 0, 24 and 48
Changes in KOOS scores
Symptoms, pain and functionality of the knee joint will be evaluated via the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Week 0, 24 and 48
Changes in 100 mm-VAS
Pain of the knee will be measured by the 100mm Visual Analogue Scale (VAS)
Time frame: Week 0, 24 and 48
Comparative Evaluation of Knee Magnetic Resonance Images (MRIs)
Comparison of pre-procedure MRI scans to those obtained at pre-dosing and at months 6 and 12 by an independent radiographic reviewer
Time frame: Week 0, 24 and 48
Changes in ICRS Cartilage Repair Assessment
Time frame: week 0 and 48
Changes in IKDC Subjective Knee Evaluation
Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)
Time frame: Week 0 and 24
Changes in KOOS QOL Sub-scale scores
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Asan Medical Center
Seoul, South Korea
Ewha Womans University Mokdong Hospital
Seoul, South Korea
Time frame: Week 0, 24 and 48
Proportion of Patients Use of Rescue Medication
Time frame: Week 12, 24 and 48