TissueGene, is a Rockville, Md.-based biopharmaceutical company focused on developing novel regenerative therapies, has completed patient enrollment for a U.S. phase II clinical trial of TG-C in patients with severe osteoarthritis of the knee.
TG-C is a therapy that involves human allogeneic chondrocytes developed to produce the therapeutic protein TGF-beta1 to regenerate cartilage.
The randomized, double-blind, placebo-controlled study has been designed to evaluate the safety and efficacy of TG-C in patients with Grade 3 chronic degenerative joint disease (DJD) of the knee. This multi-center study has been conducted at five hospitals and clinical research centers across the country specializing in orthopedics. Patients have received an intra-articular injection of either TG-C or placebo to the damaged joint area. Patients in this study are being followed for two years with the primary efficacy endpoint analysis being conducted once all patients have reached their one year follow-up.
In conjunction with this milestone, TissueGene's licensing partner, Kolon Life Science, a South Korea-based biochemical company, has completed patient enrollment for a phase IIb study of TG -C.
"We are very pleased with the clinical progress of TG-C in both the U.S. and Korea and look forward to reporting our phase II data in 2013," said Dr. Kwan Hee Lee, CMO of TissueGene.