Degenerative Arthritis Clinical Trial
Official title:
A Dose-escalating, Single-center, Phase I Clinical Trial to Investigate the Safety and Biological Efficacy of TissueGene-C in Degenerative Arthritis Patients.
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.
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