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Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis

Degenerative Arthritis Clinical Trial

Official title:
A Placebo Controlled, Double-blind, Randomized, Parallel-group, Multi-center Phase III Study to Determine the Efficacy and Safety of TissueGene-C in Patients With Degenerative Arthritis

Clinical Trial Summary

The purpose of this study is to determine whether TissueGene-C, an allogeneic human chondrocytes expressing Transforming Growth Factor(TGF)-b1, is effective and safe in patients with degenerative arthritis.

Clinical Trial Description

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 the Phase 3 clinical trial , we will compare TissueGene-C to placebo in 26, 52 weeks trial with 156 outpatients who have osteoarthritis. The outpatients are randomized to TissueGene-C or placebo in 1:1 ratio, and they will be monitored and recorded in terms of alleviating symptoms, sports activities, function of the knee, and the presence of adverse events. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02072070
Study type Interventional
Source Kolon Life Science
Contact
Status Completed
Phase Phase 3
Start date November 2013
Completion date August 2015
View Details
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