ABOUT THE STUDY
Osteoarthritis is a joint disease that causes an inflammatory response (the body’s response to disease or injury such as redness, swelling, warmth, and pain), which worsens over time. Osteoarthritis is a serious condition that can affect the entire joint structure including cartilage, bone, synovium (membrane that covers the joint and releases fluid), ligaments (connects bones to each other), and meniscus (cartilage between joints). Cartilage is a thin covering on the surface of joints that acts as a cushion, which protects your bones and helps your joints to move smoothly.
The Sponsor has developed TG-C to reduce damage caused by osteoarthritis. TG-C is a gene transfer product made from cartilage cells from a single healthy living human donor. Gene transfer means that copies of a gene are put into other living cells to make the product. These donor cartilage cells have been changed in a laboratory to make a growth factor called TGF‑β1. TGF‑β1 is a type of protein called a cytokine that is normally present in your body in low levels. In animal studies, TGF‑β1 has been shown to cause the growth of cartilage. In a laboratory, a retrovirus (a type of virus) is used to insert the copied gene needed to make TGF‑β1 and put it into the human donor cartilage cells. The retrovirus that is used to insert the gene into the new cell is called a vector. TG-C is being studied in subjects who have osteoarthritis of the knee to see if it will cause new cartilage to grow in the diseased joint.