NCT02341378已完成2 期
A Multicenter, Single-blind, Phase 2A Clinical Trial to Evaluate the Efficacy and Safety of TissueGene-C, a Cell-mediated Gene Therapy, in Degenerative Arthritis Patients
Kolon Life Science5 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2009年8月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 5
- 主要终点
- Changes in IKDC Subjective Knee Evaluation
研究概览
简要总结
To assess the efficacy and safety of the intra-articular injection of TissueGene-C in patients with degenerative arthritis of the knee
详细描述
TissueGene-C is a biological new drug which consists of non-transduced chondrocytes and transduced chondrocytes that express Transforming Growth Factor(TGF)-b1 to regenerate the damaged cartilage.
During the clinical trial Phase 2A, we compare low dose or high dose TissueGene-C in 6 months trial with 28 outpatients who have degenerative arthritis. The patients are randomized to two dose levels of TisssueGene-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.
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
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 45 years or more
- •With grade 4 degenerative arthritis of the knee [based on the International Cartilage Repair Society(ICRS) evaluation criteria from the MRI results]
- •With less than 6 cm2major lesions
- •With major lesions (grade 4) concentrated in only one section of the knee and considered the main cause of the clinical symptoms
- •Unresponsive to conventional symptomatic treatment
- •Healthy and with no major physical examination, hematology, serum chemistry, and urine test findings 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
- •Abnormal screening laboratory test (hematology, serum, and urine test) findings
- •Took anti-inflammatory medications (prescribed or over-the-counter), including natural medicines, within 14 days before the injection of the investigational product
- •Took antirheumatic drugs (e.g., methotrexate or antimetabolites) within three months before enrollment in this study
- •Has a history of drug abuse within one year from the enrolment, or has positive results in the urine drug test or serum alcohol test at the screening visit
- •Received an injection in the target knee within two months before enrollment in this study
- •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, and synovial chondromas)
- •With a current infectious disease, including HIV or hepatitis
- •Has any of the following clinically significant diseases:
- •heart disease [e.g., myocardial infarction, arrhythmia, other serious heart disease, coronary artery bypass graft (CABG)]
- •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 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 by the investigator inappropriate for participation in this study
结局指标
主要结局
Changes in IKDC Subjective Knee Evaluation
时间窗: Week 0, 12 and 24
Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)
次要结局
- Number of Participants with Adverse Events(Week 0, 2, 4, 12 and 24)
- Evaluation of Physical examination and laboratory tests(Week 0, 2, 4, 12 and 24)
- Changes in 100 mm-VAS(Week 0, 12 and 24)
- Comparative Evaluation of Knee MRI(Week 0, 12 and 24)
- Changes in WOMAC scores(Week 0, 12 and 24)
研究者
研究点 (5)
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