Study of TG-C in Patients With Grade 3 Degenerative Joint Disease of the Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Joint Diseases
Intervention: TissueGene-C; Normal Saline
Intervention description: Single intraarticular injection at 3 x 10e7 cells; Single intraarticular injection of normal saline as a placebo control
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Cartilage; Knee; Osteoarthritis

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.
    

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.