Summary:
This is a Phase 3 clinical research study of an investigational new drug named TG-C to treat knee osteoarthritis (degenerative joint disease). If you meet the study criteria and agree to take part in this study, you will come to the study center for about 11 visits over the duration of 2 years.
The possible direct benefits of taking part in this study are delayed progression of your knee osteoarthritis, longer preservation of your knee joint, and improved quality of life. 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.
Qualified Participants Must:
• Be 40 years of age or older
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Have documented Grade 2 or 3 Osteoarthritis
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Not use a crutch, cane, or walker
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Not uses chronic narcotics (longer than 21 days)
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Not have had surgery of the target knee within the last 6 months
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Not have had a previous knee cartilage repair
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Not have any major organ system disorders or active malignancy within the last 5 years