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

Launched by KOLON TISSUEGENE, INC. · Oct 13, 2010

Keywords

ClinConnect Summary

Protocol TGC09201 is a multi-center, double-blind, placebo-controlled, randomized study. A total of one hundred (100) adults with grade 3 chronic degenerative joint disease (DJD) of the knee joint (as determined by radiographic examination) will be enrolled into the study. TissueGene-C will be administered intra-articularly once via x-ray guidance. TissueGene-C will be administered at a dose of 3 x 10e7 cells. Patients receiving control treatment will receive a single normal saline injection.

The objectives of this study are to:

1. Evaluate the efficacy of TissueGene-C with regard to knee...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or Female subject
• • 2. Age 18 to 70 years
• • 3. In general good health as evidenced by physical examination, normal hematology, serum chemistry, and urinalysis screening laboratory results, and a negative history of significant organ system disorders. All laboratory values must be within 20% of normal ranges.
• • 1. Body Mass Index (BMI) should be between '18.5 - 45.5'. The applied scale is the same for both men and women.
• • 2. Blood Pressure measurements - Systolic Blood Pressure should be between 90-160mm. Hg, and Diastolic Blood Pressure between 50-90mm.Hg,
• • 4. Patients with Grade 3 chronic osteoarthritis of the knee as determined by the Radiographic Criteria of Kellgren and Lawrence.
• • 5. Symptom of pain for more than four (4) consecutive months and intensity of ≥ 40 and ≤ 90 on the 100-mm scale.
• • 6. Patients should be cleared to use protocol specified equipment: 3T MRI.
• • 7. Patients providing written informed consent after the nature of the study is fully explained and understood by the patient.
• 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.