Safety Study of TissueGene-C in Degenerative Joint Disease of the Knee
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Joint Diseases
Intervention: TissueGene-C; Placebo
Intervention description: TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection; Placebo control (DMEM)
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: osteoarthritis, knee

Summary:

      The study is being conducted to investigate the safety and activity of TissueGene-C injected
      into the knee joint of patients with chronic degenerative joint disease (DJD) who will be
      undergoing total knee replacement.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or Female subjects

          2. Age 18 years and older

          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.

          4. Patients with Degenerative Joint Disease (DJD) of the knee that is refractory to
             existing drug therapies and who are scheduled for Total Knee Arthroplasty.

          5. Based on Radiographic findings, defect should be more than 2 cm.

          6. Patients providing written informed consent, after the nature of the study, are fully
             explained.

          7. Body Mass Index (BMI) should be between '18.5 - 45.5'. The applied scale is the same
             for both men and women.

          8. Blood Pressure measurements - Systolic Blood Pressure (SBP) should be between
             90-160mm. Hg, and Diastolic Blood Pressure (DBP) between 50-90mm.Hg,

          9. Osteoarthritis confirmed by the Radiographic Criteria of Kellgren and Lawrence

         10. Symptom of pain for more than four (4) consecutive months and intensity greater than
             Grade 4 on the 11-point numeric scale.

        Exclusion Criteria:

          1. Patients with abnormal hematology, serum chemistry, or urinalysis screening laboratory
             results

          2. Patients taking anti-inflammatory medications (prescription or over-the-counter),
             including herbal therapies, within 14 days of baseline visit

          3. Patients with a recent (within 1 year) history of drug abuse and/or a positive urine
             drug/alcohol test at the time of screening

          4. Patients receiving injections to the treated knee within 2 months prior to study entry

          5. Patients who are pregnant or currently breast-feeding children

          6. 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, and synovial chondromatosis.

          7. Patients with ongoing infectious disease, including HIV and hepatitis

          8. Patients with clinically significant cardiovascular, renal, hepatic, endocrine
             disease, cancer, or Type I diabetes

          9. Patients participating in a study of an experimental drug or medical device within 30
             days of study entry.

         10. Positive drug screen at screening visit