Efficacy and Safety Study of TissueGene-C Mixed With Fibrin-glue for the Patients With Degenerative Arthritis

Launched by KOLON LIFE SCIENCE · Apr 5, 2013

Keywords

ClinConnect Summary

TissueGene-C is a biological new drug which consists of non-transduced chondrocytes and transduced chondrocytes that express TGF-b1 to regenerate the damaged cartilage.

During the clinical trial Phase 2, the investigators compare low dose or high dose TissueGene-C in 12 - months trial with 18 outpatients who have degenerative arthritis. The patients are randomized to two dose levels of TissueGene-C by 1:1 ratio, and they are monitored and recorded for alleviating symptoms, sports activities, function of the knee, and the presence of adverse events.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Female or male aged 18 years or more
• • 2. Diagnosed with degenerative arthritis of the knee
• • 3. With an IKDC score of 60 or lower at the screening visit
• • 4. With a BMI of higher than18.5 and lower than 30
• • 5. With an International Cartilage Repair Society(ICRS) Grade IV cartilage damage in the major lesions, as confirmed through an MRI scan
• • 6. With major lesions concentrated in one section of the knee, and with the major lesions considered the main cause of the clinical symptoms
• • 7. With major lesions defect size 2 cm2 \~ 10cm2
• • 8. With no alleviation of the symptoms even after at least three months of non-surgical treatment
• • 9. Healthy, with no major findings from the physical examination, hematology, serum chemistry, and urine tests, and no significant medical history
• • 10. Agreed to use an effective contraceptive method during the study period
• • 11. 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. Mechanical axis (HKA) is greater than 5°
• • 3. Patients receiving injections to the treated knee within 2 months prior to study entry
• • 4. Patients who are pregnant or currently breast-feeding children
• • 5. With another joint disease (e.g., inflammatory arthritis, infectious arthritis)
• • 6. With an infectious disease, including HIV or hepatitis
• 7. With any of the following clinically significant diseases:
• • heart disease \[e.g., myocardial infarction, arrhythmia, other serious heart diseases,
• • 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)
• • 8. Participated in another clinical trial (using the investigational drug or a medical device) within 30 days before enrollment in this study
• • 9. Considered inappropriate by the investigator for participation in this study