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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see if we can safely regenerate cartilage without invasive surgery using a biologic product called TissueGene-C.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kolon TissueGene, Inc.; TissueGene, Inc.

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.