drugset / Trial / NCT02072070

Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis

NCT02072070 ↗

Phase 3 Completed 163 enrolled Kolon Life Science
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2013-11
Primary completion
2015-08
Completion
2015-08

Outcome

Met primary endpoint

paper statistically significant improvement over placebo in the total IKDC score and individual categories, and in the VAS score at 26, 39, and 52 weeks. PMID 29641281 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject TissueGene-C Cell therapy 1.8e+07 cells Other

Indications