NCT01221441

Study of TG-C in Patients With Grade 3 Degenerative Joint Disease of the Knee

A Phase II Study to Determine the Efficacy and Safety of Allogeneic Human Chondrocytes Expressing TGF-β1 (TissueGene-C) in Patients With Grade 3 Chronic Degenerative Joint Disease of the Knee

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Kolon TissueGene, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to see if we can safely regenerate cartilage without invasive surgery using a biologic product called TissueGene-C.

Detailed description

Protocol TGC09201 is a multi-center, double-blind, placebo-controlled, randomized study. A total of one hundred (100) adults with grade 3 chronic degenerative joint disease (DJD) of the knee joint (as determined by radiographic examination) will be enrolled into the study. TissueGene-C will be administered intra-articularly once via x-ray guidance. TissueGene-C will be administered at a dose of 3 x 10e7 cells. Patients receiving control treatment will receive a single normal saline injection. The objectives of this study are to: 1. Evaluate the efficacy of TissueGene-C with regard to knee functionality and symptoms of knee osteoarthritis including pain. 2. Evaluate the safety of administration of a single intra-articular dose of TissueGene-C as evidenced by observation of the injection site for irritation or other abnormalities, the incidence and severity of adverse events, and the changes in physical examination findings and laboratory tests, including immune analyses. 3. Evaluate the incidence and dose of analgesia and/or anti-inflammatory medication. 4. Evaluate the regeneration of hyaline cartilage as determined by 3T magnetic resonance imaging (MRI). 5. Evaluate distribution of hChonJb#7 cells out of the injection site. 6. Evaluate the efficacy of TissueGene-C by evaluating the need for total knee arthroplasty after treatment

Conditions

• Osteoarthritis, Knee

Interventions

Type	Name	Description
BIOLOGICAL	TissueGene-C	Single intraarticular injection at 3 x 10e7 cells
DRUG	Normal Saline	Single intraarticular injection of normal saline as a placebo control

Timeline

• Start date: 2011-05-01
• Primary completion: 2013-10-01
• Completion: 2014-10-01
• First posted: 2010-10-15
• Last updated: 2016-02-15
• Results posted: 2016-02-15

Locations

5 sites across 1 country: United States