Status:
COMPLETED
Efficacy and Safety Study of TissueGene-C Mixed With Fibrin-glue for the Patients With Degenerative Arthritis
Lead Sponsor:
Kolon Life Science
Conditions:
Degenerative Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether TissueGene-C, allogeneic human chondrocytes expressing Transforming Growth Factor(TGF)-b1, mixed with fibrin-glue is effective and safe in patients wi...
Detailed Description
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 Phas...
Eligibility Criteria
Inclusion
- Female or male aged 18 years or more
- Diagnosed with degenerative arthritis of the knee
- With an IKDC score of 60 or lower at the screening visit
- With a BMI of higher than18.5 and lower than 30
- With an International Cartilage Repair Society(ICRS) Grade IV cartilage damage in the major lesions, as confirmed through an MRI scan
- With major lesions concentrated in one section of the knee, and with the major lesions considered the main cause of the clinical symptoms
- With major lesions defect size 2 cm2 \~ 10cm2
- 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
- Showed clinically significant hematology, serum chemistry, and urine test results at the screening visit
- Mechanical axis (HKA) is greater than 5°
- Patients receiving injections to the treated knee within 2 months prior to study entry
- Patients who are pregnant or currently breast-feeding children
- With another joint disease (e.g., inflammatory arthritis, infectious arthritis)
- 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,
- 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
- Considered inappropriate by the investigator for participation in this study
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT01825811
Start Date
October 1 2012
End Date
June 1 2014
Last Update
January 22 2015
Active Locations (6)
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1
Kyungpook National University Hospital
Daegu, South Korea, 700-721
2
Inha University Hospital
Incheon, South Korea, 400-711
3
Seoul National University Hospital
Seoul, South Korea, 110-744
4
Samsung Medical Center
Seoul, South Korea, 135-710