Abstract
Purpose: TG-C (3:1 mixture of non-irradiated allogeneic human chondrocytes and irradiated transduced allogeneic human GP2-293 cells over-expressing transforming growth factor-beta 1 [TGF-β1]) is a cell-mediated gene therapy that is in clinical development for the treatment of knee osteoarthritis (OA). The safety and efficacy of a single intra-articular injection of TG C into the knee joint have been evaluated in a Phase 1, multicenter, single-blind, randomized, placebo-controlled, dose escalation trial, a Phase 2, multicenter, double-blind, randomized, placebo-controlled, fixed-dose trial, and an ongoing Phase 3, multicenter, double-blind, randomized, placebo-controlled trial.
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