Abstract

Purpose: TG-C (3:1 mixture of non-irradiated allogeneic human chondrocytes and irradiated allogeneic human GP2-293 cells transduced with a retroviral vector that encodes transforming growth factor-beta 1 [TGF-β1]) is a cell-mediated gene therapy that is under development for the treatment of osteoarthritis (OA) of the knee. 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 and in a Phase 2, multicenter, double-blind, randomized, placebo-controlled, fixed-dose trial.

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