NCT01825811

Efficacy and Safety Study of TissueGene-C Mixed With Fibrin-glue for the Patients With Degenerative Arthritis

A Single-blind, Randomized, Parallel-group, Multi-center Phase 2 Study to Determine the Efficacy and Safety of TissueGene-C Mixed With Fibrin-glue in Patients With Degenerative Arthritis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (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, allogeneic human chondrocytes expressing Transforming Growth Factor(TGF)-b1, mixed with fibrin-glue is effective and safe in patients with degenerative arthritis.

Detailed description

TissueGene-C is a biological new drug which consists of non-transduced chondrocytes and transduced chondrocytes that express TGF-b1 to regenerate the damaged cartilage. During the clinical trial Phase 2, the investigators compare low dose or high dose TissueGene-C in 12 - months trial with 18 outpatients who have degenerative arthritis. The patients are randomized to two dose levels of TissueGene-C by 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)	TissueGene-C at 1.0 x 10\^6 cells mixed with fibrin-glue
BIOLOGICAL	TissueGene-C (High dose)	TissueGene-C at 3.0 x 10\^6 cells mixed with fibrin-glue

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-04-01
• Completion: 2014-06-01
• First posted: 2013-04-08
• Last updated: 2015-01-22

Locations

6 sites across 1 country: South Korea