Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis
Degenerative Arthritis
About this trial
This is an interventional treatment trial for Degenerative Arthritis focused on measuring chondrocyte cells, Osteoarthritis, gene therapy
Eligibility Criteria
Inclusion Criteria:
- Male or female patients at least 19 years of age
- Patients diagnosed with degenerative arthritis
- Patients with IKDC(Knee Documentation Committee subjective score) score of 60 or below
- Patients with 100 mm VAS(Visual Analog Scale) score of 40 or above
- With Grade 3 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence
- With an International Cartilage Repair Society(ICRS) Grade III or IV cartilage damage in the major lesions, as confirmed through an MRI scan
- With a Body Mass Index(BMI) of higher than18.5 and lower than 30
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
- With major lesions concentrated in one section of the knee, and with the major lesions considered the main cause of the clinical symptoms
- With no alleviation of the symptoms even after at least three months of non-surgical treatment
- Healthy, with no major findings from the physical examination, hematology, serum chemistry, and urine tests, and no significant medical history
- Agreed to use an effective contraceptive method during the study period
- Voluntarily agreed to participate in this study, and signed the informed consent form
Exclusion Criteria:
- Showed clinically significant hematology, serum chemistry, and urine test results at the screening visit
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),
- Patient who had skin disease around target knee
- patients who have a positive skin reaction to CS-10
- Patients who had been administered with drugs such as oriental medicine, glucosamine and chondroitin within 14 days of baseline visit
- Patients taking steroidal anti-inflammatory medications within 14 days of baseline visit
- Patients with severe pain in other areas that could effect the diagnosis of the symptoms of the
- History of surgery like arthroendoscopy within the past 6 months on the target knee
- Patients who had been administered with immunosuppressants, including antirheumatic drugs (including methotrexate or antimetabolite), within the past 3 months
- Patients who had been treated with physical therapy or herbal remedy (acupuncture, heat etc.) within 2 weeks of baseline visit
- History of injection within the past 3 months on the target knee
- Pregnant or breastfeeding female
- 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)
- With an infectious disease, including HIV or hepatitis
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)
- Participated in another clinical trial (using the investigational drug or a medical device) within 30 days before enrollment in this study
- Patients who administered the TissueGene-C from past clinical trial
- Considered inappropriate by the investigator for participation in this study
Sites / Locations
- Chungbuk National University Hospital
- Kyungpook National Univ. Hospital
- Inha University Hospital
- Chonbuk National University Hospital
- Inje University Seoul Paik Hospital
- Seoul National University Hospital
- Hanyang University Medical Center
- Samsung Medical Center
- The Catholic University of Korea Seoul St. Mary's Hospital
- ASAN Medical Center
- Ewha Womans University Mokdong Hospital
- Ulsan University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
TissueGene-C
Placebo
Single intra-articular injection to the damaged knee joint at a dose of 1.8 x 10^7 cells
Single intra-articular injection to the damaged knee joint