Clinical trial: Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis (NCT02072070)

Eligibility criteria:
Inclusion Criteria:

          1. Male or female patients at least 19 years of age

          2. Patients diagnosed with degenerative arthritis

          3. Patients with IKDC(Knee Documentation Committee subjective score) score of 60 or below

          4. Patients with 100 mm VAS(Visual Analog Scale) score of 40 or above

          5. With Grade 3 osteoarthritis as determined by the radiographic criteria of Kellgren and
             Lawrence

          6. With an International Cartilage Repair Society(ICRS) Grade III or IV cartilage damage
             in the major lesions, as confirmed through an MRI scan

          7. With a Body Mass Index(BMI) of higher than18.5 and lower than 30

          8. Patients who satisfies the clinical/radiational criteria by the American College of
             Rheumatology (ACR) guidelines, and applies to one of the following.

               -  Older than 50

               -  Morning stiffness for less than 30 minutes

               -  Crepitus and Osteophytes

          9. With major lesions concentrated in one section of the knee, and with the major lesions
             considered the main cause of the clinical symptoms

         10. With no alleviation of the symptoms even after at least three months of non-surgical
             treatment

         11. Healthy, with no major findings from the physical examination, hematology, serum
             chemistry, and urine tests, and no significant medical history

         12. Agreed to use an effective contraceptive method during the study period

         13. Voluntarily agreed to participate in this study, and signed the informed consent form

        Exclusion Criteria:

          1. Showed clinically significant hematology, serum chemistry, and urine test results at
             the screening visit

          2. Regarding inclusion criteria 6. following patients should not be included

               -  patients with a major lesion of ICRS grade 4 which is larger than 6cm2(for
                  patient with ICRS grade 4)

               -  patients with a major lesion of ICRS grade 3 which is larger than 6cm2(for
                  patient without a ICRS grade 4),

          3. Patient who had skin disease around target knee

          4. patients who have a positive skin reaction to CS-10

          5. Patients who had been administered with drugs such as oriental medicine, glucosamine
             and chondroitin within 14 days of baseline visit

          6. Patients taking steroidal anti-inflammatory medications within 14 days of baseline
             visit

          7. Patients with severe pain in other areas that could effect the diagnosis of the
             symptoms of the

          8. History of surgery like arthroendoscopy within the past 6 months on the target knee

          9. Patients who had been administered with immunosuppressants, including antirheumatic
             drugs (including methotrexate or antimetabolite), within the past 3 months

         10. Patients who had been treated with physical therapy or herbal remedy (acupuncture,
             heat etc.) within 2 weeks of baseline visit

         11. History of injection within the past 3 months on the target knee

         12. Pregnant or breastfeeding female

         13. With another joint disease apart from degenerative arthritis (e.g., systemic rheumatic
             inflammatory disease associated with the knee or chondrocalcinosis, hemachromatosis,
             inflammatory arthritis, necrosis of the trochanter, Paget's disease adjacent to a
             joint in the femur or tibia, ochronosis, hemophilic arthropathy, infectious arthritis,
             Charcot's disease in the knee joint, villonodular synovitis, synovial chondromas)

         14. With an infectious disease, including HIV or hepatitis

         15. With any of the following clinically significant diseases:

               -  heart disease (e.g., myocardial infarction, arrhythmia, other serious heart
                  diseases, coronary artery bypass graft)

               -  kidney disease (e.g., chronic renal failure, glomerulonephritis)

               -  liver disease (e.g., liver cirrhosis, fatty liver, acute or chronic liver
                  disease)

               -  endocrine disease (e.g., hyperthyroidism, hypothyroidism, thyroiditis, diabetes
                  insipidus, Cushing's disease)

               -  insulin-dependent diabetes mellitus

               -  medical history of past or current malignant tumor

               -  In particular, the tumors that TissueGene-C may aggravate can be screened using
                  the following tests:

                    -  Leukemia (White Blood Cell level in the hematology)

                    -  Osteochondroma, Chondromas, Chondroblastoma, Chondromyxoid fibroma,
                       Chondrosarcoma (Alkaline phosphatase level in the hematology)

         16. Participated in another clinical trial (using the investigational drug or a medical
             device) within 30 days before enrollment in this study

         17. Patients who administered the TissueGene-C from past clinical trial

         18. Considered inappropriate by the investigator for participation in this study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.


Patient description (medical language): A 66-year-old woman comes to the office due to joint pain in the hands and periodic morning stiffness that lasts less than 15 minutes.  The pain is moderately severe and worsens with daily activity. The patient used Tylenol with minimal relief.  Past medical history is notable for hypertension and hypercholesteremia.  Physical examination shows firm nodules over the distal interphalangeal joints, bilaterally. The patient has pain in her knees as well. The knees are stiff in the morning for less than 30 minutes and become worse with climbing stairs. She has some sensation of bone friction during activity. X-ray shows narrowing of the joint space, subchondral bone sclerosis and osteophyte formation along the joints.

Patient description (patient's own words): I'm a 66-year-old woman and I went to my doctor's office because of a bloody joint pain in my hands that has been lasting for a while. The pain comes and go in the morning usually. I feel like a stiffness that last less than 15 minutes. The pain is moderately severe but it gets worse when I'm using my hands. I used Tylenol which helped a little. Apart from that, I suffer from hypertension and high cholesterol. The doctor made me notice that I have bumps around both of my hand joints. I also suffer from my knees and they are also stiff in the morning for around 30 min. It's even worse when I climb up the stairs! I also feel like my bones are rubbing against each other when I'm moving. The X-ray showed that I have narrow joint space, I have sclerosis, and abnormal growths of bone along my joints.

Does the patient match the trial criteria? Entailment