The primary purpose of the this study is to evaluate the safety of TissueGene-C, a gene therapy product that uses allogenic human chondrocytes expressing Transforming Growth Factor(TGF)-β1 by assessing the inflammation at the injection site, the incidence and severity of the adverse events, the physical examination findings, and the laboratory test results after the intra-articular injection of TissueGene-C. And Secondary purpose is to evaluate the biological efficacy (knee pain, range of motion, functional tests, and MRI) of TissueGene-C and the distribution of TissueGene-C outside the injection site.
TissueGene-C is a biological new drug which consists of normal chondrocyte cells and transduced chondrocyte cells that express growth factor to modify osteoarthritis symptom for long term period. During clinical trial Phase 1, we compare three different dose levels of TisssueGene-C in 6 months with 12 outpatients with degenerative arthritis. The patients are randomized by three different dose levels of TisssueGene-C in 1:1:1 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
12
3.0 x 10\^6 cells
1.0 x 10\^7 cells
3.0 x 10\^7 cells
Samsung Medical Center
Seoul, South Korea
Number of Participants with Adverse Events after the administration of TissueGene-C
Number of Participants with Adverse Events after the administration of TissueGene-C
Time frame: 6 months
Changes in MRI scan
Change in the MRI scan results after the administration of TissueGene-C
Time frame: before and 28 days, 3 months, and 6 months
Change in the Knee Society Clinical Rating System(KSCRS) test results
Comparative Evaluation of knee exam
Time frame: before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
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: before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
Changes in 100 mm-VAS
Pain of the knee will be measured by the 100mm Visual Analogue Scale (VAS)
Time frame: before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
Analysis of the TGF-β1 expression using Enzyme-linked Immunosorbent Assay(ELISA) and Polymerase Chain Reaction(PCR)
Analysis of the TGF-β1 expression using Enzyme-linked Immunosorbent Assay(ELISA) and Polymerase Chain Reaction(PCR)
Time frame: before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
Replication-competent retrovirus test (RCR test)
Replication-competent retrovirus test (RCR test)
Time frame: before and 7 days, 14 days, 21 days, 28 days, 3 months, and 6 months
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