NCT02341378

Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis

A Multicenter, Single-blind, Phase 2A Clinical Trial to Evaluate the Efficacy and Safety of TissueGene-C, a Cell-mediated Gene Therapy, in Degenerative Arthritis Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Kolon Life Science · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

To assess the efficacy and safety of the intra-articular injection of TissueGene-C in patients with degenerative arthritis of the knee

Detailed description

TissueGene-C is a biological new drug which consists of non-transduced chondrocytes and transduced chondrocytes that express Transforming Growth Factor(TGF)-b1 to regenerate the damaged cartilage. During the clinical trial Phase 2A, we compare low dose or high dose TissueGene-C in 6 months trial with 28 outpatients who have degenerative arthritis. The patients are randomized to two dose levels of TisssueGene-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 6.0x10\^6 cells
BIOLOGICAL	TissueGene-C(High dose)	TissueGene-C at 1.8x10\^7 cells

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-06-01
• Completion: 2010-10-01
• First posted: 2015-01-19
• Last updated: 2015-01-22

Locations

3 sites across 1 country: South Korea