Degenerative Arthritis Clinical Trial
Official title:
A Single-blind, Randomized, Parallel-group, Multi-center Phase 2 Study to Determine the Efficacy and Safety of TissueGene-C Mixed With Fibrin-glue in Patients With Degenerative Arthritis
Verified date | January 2015 |
Source | Kolon Life Science |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
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 with degenerative arthritis.
Status | Completed |
Enrollment | 18 |
Est. completion date | June 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Kyungpook National University Hospital | Daegu | |
Korea, Republic of | Inha University Hospital | Incheon | |
Korea, Republic of | Asan Medical Center | Seoul | |
Korea, Republic of | Ewha Womans University Mokdong Hospital | Seoul | |
Korea, Republic of | Samsung Medical Center | Seoul | |
Korea, Republic of | Seoul National University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Kolon Life Science |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in IKDC Subjective Knee Evaluation | Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC) | Week 0 and 48 | No |
Secondary | Changes in WOMAC scores | Pain, stiffness, and physical function of the knee will be measured by the Western Ontario and McMaster Universities (WOMAC) | Week 0, 24 and 48 | No |
Secondary | Changes in KOOS scores | Symptoms, pain and functionality of the knee joint will be evaluated via the Knee Injury and Osteoarthritis Outcome Score (KOOS) | Week 0, 24 and 48 | No |
Secondary | Changes in 100 mm-VAS | Pain of the knee will be measured by the 100mm Visual Analogue Scale (VAS) | Week 0, 24 and 48 | No |
Secondary | Comparative Evaluation of Knee Magnetic Resonance Images (MRIs) | Comparison of pre-procedure MRI scans to those obtained at pre-dosing and at months 6 and 12 by an independent radiographic reviewer | Week 0, 24 and 48 | No |
Secondary | Changes in ICRS Cartilage Repair Assessment | week 0 and 48 | No | |
Secondary | Changes in IKDC Subjective Knee Evaluation | Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC) | Week 0 and 24 | No |
Secondary | Changes in KOOS QOL Sub-scale scores | Week 0, 24 and 48 | No | |
Secondary | Proportion of Patients Use of Rescue Medication | Week 12, 24 and 48 | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT02820766 -
Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting
|
N/A | |
Withdrawn |
NCT01308515 -
Vanguard Knee Anterior Stabilized Versus Posterior Stabilized Bearing Study
|
N/A | |
Terminated |
NCT03247023 -
Long Term Follow-up of Integra® Cadence™ Total Ankle System in Primary Ankle Joint Replacement
|
||
Terminated |
NCT05357664 -
PINNACLE® DM RSA Study
|
N/A | |
Terminated |
NCT01366989 -
INBONE Total Ankle Arthroplasty(TAA)Using Calcaneal Stem Fixation
|
N/A | |
Not yet recruiting |
NCT02286973 -
Combined Administration of Intravenous and Topical Tranexamic Acid in Total Knee Arthroplasty
|
Phase 1 | |
Completed |
NCT02072070 -
Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis
|
Phase 3 | |
Completed |
NCT01684371 -
The Effects of Elmore Oil on Patients With Osteoarthritis
|
N/A | |
Recruiting |
NCT00891501 -
The Use of Autologous Bone Marrow Mesenchymal Stem Cells in the Treatment of Articular Cartilage Defects
|
Phase 2/Phase 3 | |
Completed |
NCT03000712 -
Investigator Initiated Trial to Evaluate the Efficacy and Safety of Intra-articular Injection of ADMSC Comared to Negative Control After High Tibial Osteotomy in the Osteoarthritis Patients.
|
N/A | |
Withdrawn |
NCT04057885 -
To Determine the Gait and Functional Improvement in Total Knee Arthroplasty
|
N/A | |
Completed |
NCT04815070 -
Gastric Volume in Diabetic Patients Undergoing Staged Bilateral Total Knee Arthroplasty
|
||
Active, not recruiting |
NCT02038140 -
Zimmer Trabecular Metal Total Ankle PMCF
|
N/A | |
Recruiting |
NCT02469662 -
Clinical Outcomes Study of the Nexel Total Elbow
|
N/A | |
Terminated |
NCT00588887 -
Total Knee Replacement With Duracon® and Vanguard™ Prostheses
|
N/A | |
Completed |
NCT03990805 -
A Phase 3 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis
|
Phase 3 | |
Completed |
NCT02658344 -
Clinical Trial to Evaluate Efficacy and Safety of JOINTSTEM in Patients With Degenerative Arthritis
|
Phase 2 | |
Completed |
NCT01671072 -
Efficacy and Safety Study of TissueGene-C to Degenerative Arthritis
|
Phase 2 | |
Not yet recruiting |
NCT04821102 -
Investigator Initiated Trial to Evaluate Cartilage Regeneration by Arthroscopy After JOINTSTEM Administration
|
N/A | |
Terminated |
NCT02405234 -
Ascension PyroCarbon Radial Head Study
|
N/A |