NCT01671072

Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis

A Placebo Controlled, Single-blind, Randomized, Multi-center Phase 2B Study to Determine the Efficacy and Safety of TissueGene-C, an Allogeneic Human Chondrocytes Expressing TGF-b1, in Patients With Degenerative Arthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Kolon Life Science · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

TissueGene-C is a biological new drug which consists of normal chondrocytes and transduced chondrocytes that express growth factors to regenerate the damaged cartilage tissues. In the clinical trial Phase 2b, the investigators compared TissueGene-C to placebo during 6 - months trial with 54 outpatients who have had degenerative arthritis. The outpatients are assigned to TissueGene-C or placebo in 1:1 ratio, and will be monitored and recorded for improving clinical symptoms, sports activities, and function of the knee, and for the presence of adverse events.

Conditions

• Degenerative Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	TissueGene-C	TissueGene-C at 1.8 x 10\^7 cells
DRUG	Normal Saline	Sodium chloride 0.9%, 3.5ml

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-10-01
• Completion: 2013-01-01
• First posted: 2012-08-23
• Last updated: 2015-01-22

Locations

3 sites across 1 country: South Korea