NCT02341391

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Kolon Life Science · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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 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.

Conditions

• Degenerative Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	TissueGene-C(Low dose)	3.0 x 10\^6 cells
BIOLOGICAL	TissueGene-C(Medium dose)	1.0 x 10\^7 cells
BIOLOGICAL	TissueGene-C(High dose)	3.0 x 10\^7 cells

Timeline

• Start date: 2007-02-01
• Primary completion: 2008-08-01
• Completion: 2008-09-01
• First posted: 2015-01-19
• Last updated: 2018-07-05

Locations

1 site across 1 country: South Korea