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Safety and Biological Efficacy Study of TisssueGene-C to Degenerative Arthritis

Kolon Life Science · 2007
ClinicalTrials.gov · Datasets · License: Public Domain · 2007
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gene-therapyosteoarthritis
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.
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