TG-C is an allogeneic (donor) cell therapy involving human chondrocytes (cartilage cells) that have been genetically modified to produce the therapeutic growth factor TGF-ß1 and has been developed to induce cartilage regeneration in patients with osteoarthritis. Chondrocytes, when stimulated by the transforming growth factor beta 1 (TGF-ß1), have been shown to play a critical role in both the formation and maintenance of articular cartilage by regulating the homeostasis of the hyaline cartilage matrix. Due to lack of blood supply to the joints, articular cartilage is limited in its ability to repair itself, often leading to the joint degeneration observed in osteoarthritis. The knee joint typically endures the most extensive cartilage damage from constant weight bearing activities and therefore has been the company’s primary focus. Currently, a Phase II study in the US and a Phase IIb study in Korea are being conducted to evaluate the safety and efficacy of TG-C in patients with severe osteoarthritis of the knee.
Delivered through a local injection, TG-C offers a non-invasive therapy that treats not only the symptoms but also the causes of osteoarthritis through the regeneration of cartilage. TG-C involves a mixture of unmodified and modified human chondrocytes engineered to express the growth factor TGF-ß1. Cartilage regeneration by the modified chondrocytes has been shown to be significantly enhanced by the co-injection of unmodified chondrocytes at the site of degeneration. These results suggest that production of TGF-ß1 by the modified chondrocytes serve to stimulate both the unmodified chondrocytes of TG-C and the patient’s own chondrocytes to produce the components necessary for hyaline cartilage matrix formation. By providing a mixture of modified and unmodified chondrocytes, TG-C has been specifically developed to provide the key elements – cartilage cells, TGF-ß1 protein, type II collagen and glucoseaminoglycans (GAGs) – critical to regenerate the hyaline cartilage matrix and optimize articular cartilage repair.
Technology Platform: Cell therapy
Therapeutic Protein: TGF-ß1
Function: Cartilage regeneration
Indication: Knee osteoarthritis
Delivery Method: Intra-articular injection
Development Stage: Phase II