NCT02072070已完成3 期
A Placebo Controlled, Double-blind, Randomized, Parallel-group, Multi-center Phase III Study to Determine the Efficacy and Safety of TissueGene-C in Patients With Degenerative Arthritis
Kolon Life Science12 个研究点 分布在 1 个国家目标入组 163 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 163
- 试验地点
- 12
- 主要终点
- Changes in IKDC scores
研究概览
简要总结
The purpose of this study is to determine whether TissueGene-C, an allogeneic human chondrocytes expressing Transforming Growth Factor(TGF)-b1, is effective and safe in patients with degenerative arthritis.
详细描述
TissueGene-C is a biological new drug which consists of normal chondrocyte cells and transduced chondrocyte cells that express growth factor to modify osteoarthritis symptom for long term period.
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Showed clinically significant hematology, serum chemistry, and urine test results at the screening visit
- •Regarding inclusion criteria
- •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
研究组 & 干预措施
TissueGene-C
Experimental
Single intra-articular injection to the damaged knee joint at a dose of 1.8 x 10^7 cells
干预措施: TissueGene-C (Biological)
Placebo
Placebo Comparator
Single intra-articular injection to the damaged knee joint
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in IKDC scores
时间窗: Week 0 and 52
Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)
Changes in 100 mm VAS scores
时间窗: Week 0 and 52
Pain of the knee will be measured by the 100mm Visual Analogue Scale (VAS)
次要结局
- Changes in WOMAC scores(Wekk 0, 26, 39 and 52)
- Changes in IKDC scores(Week 0, 26 and 39)
- Changes in 100 mm VAS scores(Week 0, 26 and 39)
- Changes in KOOS scores(Week 0, 26, 39 and 52)
- Changes in MRI scan(Week 0, 26 and 52)
- Changes in Joint Space Width by an independent radiographic reviewer.(Week 0, 26 and 52)
- Proportion of Patients Use of Rescue Medication.(Week 4, 12, 26, 39 and 52)
- Level of Biomarkers in blood and urine.(Week 0, 26, 39 and 52)
研究者
研究点 (12)
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