Study of TG-C in Patients With Grade 3 Degenerative Joint Disease of the Knee

Exclusion Criteria

• •1. Age 71 or older
• •2. Patients with abnormal hematology, serum chemistry, or urinalysis screening laboratory results.
• •3. Patients taking non-steroidal anti-inflammatory medications within 14 days of baseline visit unless washed out as per section 3.6.4 above.
• •4. Patients taking steroidal anti-inflammatory medications within 2 months of baseline visit.
• •5. Patients with a recent (within 1 year) history of drug abuse and/or a positive urine drug test at the time of screening.
• •6. Patients receiving injections to the treated knee within 2 months prior to study entry
• •7. Patients who are contraindicated for 3T MRI.
• •8. Patients who are pregnant or currently breast-feeding children.
• •9. Patients with systemic, rheumatic or inflammatory disease of the knee or chondrocalcinosis, hemochromatosis, inflammatory arthritis, necrosis of the femoral condyle, arthropathy of the knee associated with juxta-articular Paget's disease of the femur or tibia, ochronosis, hemophilic arthropathy, infectious arthritis, Charcot's knee joint, villonodular synovitis, synovial chondromatosis, and/or history of inflammatory arthropathy.
• •10. Patients with ongoing infectious disease, including HIV and hepatitis B or C.
• •11. Patients with clinically significant cardiovascular, renal, hepatic, endocrine disease, cancer, or Type I diabetes.
• •12. Patients participating in a study of an experimental drug or medical device within 30 days of study entry.
• •13. Patients that will be unable to comply with the requisite study follow-up and are not able to complete all of the follow-up office visits and 3T MRI exams.