TG-C is an investigational cell-based gene therapy consisting of human allogeneic chondrocytes and irradiated GP2–293 cells expressing transforming growth factor beta 1 (TGF-β1).The two cell components of TG-C are combined in the application and have been designed to work synergistically. TG-C is currently being studied in Phase III trials focused on knee osteoarthritis (KOA). TG-C is studied as a one-time, single dose, administered via an intra-articular injection into the knee.
The US Phase II study for TG-C was designed as a multicenter, double-blind, placebo-controlled, randomized study to evaluate the safety and efficacy of TG-C in 102 patients with Grade 3 chronic degenerative joint disease of the knee. The primary efficacy endpoints were change from baseline in the International Knee Documentation Committee (IKDC) Subjective Knee Evaluation at 1 year and change from baseline in Visual Analog Scale (VAS) score at 1 year. In the study, one injection demonstrated compelling efficacy results for up to 24 months in improvement in pain and function.
View US Clinical Trial
The pivotal program consists of two trials:
