NCT01671072已完成2 期
A Placebo Controlled, Single-blind, Randomized, Multi-center Phase 2B Study to Determine the Efficacy and Safety of TissueGene-C, an Allogeneic Human Chondrocytes Expressing TGF-b1, in Patients With Degenerative Arthritis
Kolon Life Science3 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2011年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 3
- 主要终点
- Changes in IKDC Subjective Score.
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 chondrocytes and transduced chondrocytes that express growth factors to regenerate the damaged cartilage tissues.
In the clinical trial Phase 2b, the investigators compared TissueGene-C to placebo during 6 - months trial with 54 outpatients who have had degenerative arthritis. The outpatients are assigned to TissueGene-C or placebo in 1:1 ratio, and will be monitored and recorded for improving clinical symptoms, sports activities, and function of the knee, and for 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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 Grade 2 or 3 osteoarthritis as determined by the radiographic criteria of Kellgren and Lawrence
- •With a Body Mass Index(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 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
- •Falls under Inclusion Criteria 6 but with the damage in the relevant lesion considered ICRS Grade IV sized more than 6 cm2
- •Took glucosamine, chondroitin, or any natural medicine within 14 days before the injection of the investigational product (but if the 14-day washout period had elapsed, the patient can be enrolled in this study)
- •Has taken anti-inflammatory drugs (prescribed or over-the-counter) within 14 days before the injection of the investigational product (but if the 14-day washout period had elapsed, the patient can be enrolled in this study)
- •Has taken immunosuppressive agents, including antirheumatic drugs (e.g., methotrexate or antimetabolites) within 3 months before enrollment in this study
- •With a history of drug abuse within one year prior to enrollment in this study, or showed positive results in the urine drug test or the 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, 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 (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 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
研究组 & 干预措施
TissueGene-C
Experimental
Single intra-articular injection to the damaged knee joint a dose of 1.8 x 10^7 cells
干预措施: TissueGene-C (Biological)
Normal Saline
Placebo Comparator
Single intra-articular injection to the damaged knee joint at the same volume
干预措施: Normal Saline (Drug)
结局指标
主要结局
Changes in IKDC Subjective Score.
时间窗: Week 0 and 24
Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)
次要结局
- Proportion of Patients Use of Rescue Medication(Week 4, 12 and 24)
- Changes in WOMAC scores.(Week 0 and 24)
- MRI scan(Week 0 and 24)
- Changes in KOOS scores.(Week 0 and 24)
- Changes in 100 mm-VAS.(Week 0 and 24)
研究者
研究点 (3)
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