Summary:
This is a Phase 3 clinical research study of investigational drug 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.
TG-C is being studied in subjects who have knee osteoarthritis and resulting knee pain to see if it will cause new cartilage to grow in the diseased joint. TG-C is composed of two different components: 1) cartilage cells from a single healthy living human donor; and 2) a gene transfer product made from GP2-293 cells. The GP2-293 cells produce a growth factor called TGFβ1. 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.
- Be male or female aged 40 years or older
- Have body mass index (BMI) between 18.5 and 40.0
- Have no clinically relevant abnormalities on physical examination or clinical laboratory testing
- Have KL Grade 2 or 3 OA of the target knee
- Not be taking opiates and/or oxycodone for pain within 2 months prior to the Screening visit
- Not have received any injection to the target knee within 2 months prior to Screening
Qualified Participants May Receive:
This is a study of the effects of TG-C treatment on osteoarthritis of the knee. This study will include men and women 40 years of age and older who have osteoarthritis of the knee that meet certain X-ray and medical standards. Eligible subjects who agree to be in this study will receive a single injection (using a needle) of either TG-C or placebo into the joint space of one of your knees called the “target” knee.
There will be no cost to you or your insurance company for the study treatment or the study related procedures and examinations. You will recevie $100 per completed visit in the form of a VISA gift card.