Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis
NCT ID: NCT02072070
Last Updated: 2017-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
163 participants
INTERVENTIONAL
2013-11-30
2015-08-31
Brief Summary
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Detailed Description
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During the Phase 3 clinical trial , we will compare TissueGene-C to placebo in 26, 52 weeks trial with 156 outpatients who have osteoarthritis. The outpatients are randomized to TissueGene-C or placebo in 1:1 ratio, and they will be monitored and recorded in terms of alleviating symptoms, sports activities, function of the knee, and the presence of adverse events.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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TissueGene-C
Single intra-articular injection to the damaged knee joint at a dose of 1.8 x 10\^7 cells
TissueGene-C
TissueGene-C at 1.8 x 10\^7 cells
Placebo
Single intra-articular injection to the damaged knee joint
Placebo
Placebo control(Normal Saline)
Interventions
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TissueGene-C
TissueGene-C at 1.8 x 10\^7 cells
Placebo
Placebo control(Normal Saline)
Eligibility Criteria
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Inclusion Criteria
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
* 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
Exclusion Criteria
19 Years
ALL
No
Sponsors
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Kolon Life Science
INDUSTRY
Responsible Party
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Principal Investigators
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Jin Gu Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Inje University
Su Hee Kyung, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kyungpook National University Hospital
Chul Won Ha, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Samsung Medical Center
Myung Chul Lee, MD, PhD
Role: STUDY_CHAIR
Seoul National University Hospital
Yong In, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
The Catholic University of Korea Seoul ST. Mary's Hospita
Seong Il Bin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Seong Do Cho, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ulsan University Hospital
Jae Doo Yoo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Ewha Womans University Mokdong
Myung Gu Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Inha University Hospital
Ju Hong Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Chonbuk National University Hospital
Ui Seong Choi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Chungbuk National University Hospital
Chung Hyeok Choi, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hanyang University
Locations
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Chungbuk National University Hospital
Cheongju-si, , South Korea
Kyungpook National Univ. Hospital
Daegu, , South Korea
Inha University Hospital
Incheon, , South Korea
Chonbuk National University Hospital
Jeonju, , South Korea
Inje University Seoul Paik Hospital
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Hanyang University Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul, , South Korea
ASAN Medical Center
Seoul, , South Korea
Ewha Womans University Mokdong Hospital
Seoul, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Countries
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References
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Chen L, Huang FL, Tang Q, Zhao ZK, Ye ZY, Liang JH. Targeted therapy for knee osteoarthritis: From basic to clinics. Medicine (Baltimore). 2025 Aug 15;104(33):e43686. doi: 10.1097/MD.0000000000043686.
Kim MK, Ha CW, In Y, Cho SD, Choi ES, Ha JK, Lee JH, Yoo JD, Bin SI, Choi CH, Kyung HS, Lee MC. A Multicenter, Double-Blind, Phase III Clinical Trial to Evaluate the Efficacy and Safety of a Cell and Gene Therapy in Knee Osteoarthritis Patients. Hum Gene Ther Clin Dev. 2018 Mar;29(1):48-59. doi: 10.1089/humc.2017.249.
Other Identifiers
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KS-TGC-01-3
Identifier Type: -
Identifier Source: org_study_id