NCT00599248

Safety Study of TissueGene-C in Degenerative Joint Disease of the Knee

A Phase 1 Study to Determine the Safety and Biological Activity of Cell-Mediated Gene Therapy Using TissueGene-C in Patients With Degenerative Joint Disease Prior to Total Knee Arthroplasty

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Kolon TissueGene, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is being conducted to investigate the safety and activity of TissueGene-C injected into the knee joint of patients with chronic degenerative joint disease (DJD) who will be undergoing total knee replacement.

Detailed description

The purpose of this first human study is to investigate the safety and biological activity of intra-articularly applied TissueGene-C in patients with chronic degenerative joint disease (DJD) who will be undergoing total knee replacement. In addition, data on joint pain, range of motion, and functionality will be obtained in this patient population prior to total knee replacement. The primary objective of this study is to evaluate the safety and biological activity of intra-articularly administered TissueGene-C as evidenced by observation of the injection site for irritation or other abnormalities affecting the incidence and severity of adverse events, and the changes in physical examination findings and laboratory tests as compared to the placebo control. The secondary objectives of this study are to: 1. Evaluate the dose response of the hChonJb#7 cells in grafting at the defect as compared to the placebo control. 2. Evaluate distribution of hChonJb#7 cells out of the injection site. 3. Evaluate the regeneration of hyaline cartilage as determined by the histological analysis of the resected knee tissue. 4. Evaluate the joint for evidence of tissue overgrowth or transformation. 5. Evaluate the biological activity of TissueGene-C on joint pain, range of motion and functionality as compared to the placebo control

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
BIOLOGICAL	TissueGene-C	TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection
BIOLOGICAL	Placebo	Placebo control (DMEM)

Timeline

• Start date: 2007-01-01
• Primary completion: 2009-05-01
• Completion: 2010-05-01
• First posted: 2008-01-23
• Last updated: 2017-07-07
• Results posted: 2016-06-30

Locations

2 sites across 1 country: United States