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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 6
- 主要终点
- Changes in IKDC Subjective Knee Evaluation
研究概览
简要总结
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.
详细描述
TissueGene-C is a biological new drug which consists of non-transduced chondrocytes and transduced chondrocytes that express TGF-b1 to regenerate the damaged cartilage.
During the clinical trial Phase 2, the investigators compare low dose or high dose TissueGene-C in 12 - months trial with 18 outpatients who have degenerative arthritis. The patients are randomized to two dose levels of TissueGene-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
- 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 a 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 major lesions defect size 2 cm2 ~ 10cm2
- •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
- •Mechanical axis (HKA) is greater than 5°
- •Patients receiving injections to the treated knee within 2 months prior to study entry
- •Patients who are pregnant or currently breast-feeding children
- •With another joint disease (e.g., inflammatory arthritis, infectious arthritis)
- •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,
- •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 (Low dose)
TissueGene-C (1.0 x 10^6 cells per cm^2 of the cartilage defect) combined with fibrin-glue
干预措施: TissueGene-C (Low dose) (Biological)
Experimental: TissueGene-C (High dose)
TissueGene-C (3.0 x 10^6 cells per cm^2 of the cartilage defect) combined with fibrin-glue
干预措施: TissueGene-C (High dose) (Biological)
结局指标
主要结局
Changes in IKDC Subjective Knee Evaluation
时间窗: Week 0 and 48
Symptoms, sports activities, and function of the knee will be measured by the International Knee Documentation Committee (IKDC)
次要结局
- Changes in KOOS scores(Week 0, 24 and 48)
- Comparative Evaluation of Knee Magnetic Resonance Images (MRIs)(Week 0, 24 and 48)
- Changes in KOOS QOL Sub-scale scores(Week 0, 24 and 48)
- Changes in WOMAC scores(Week 0, 24 and 48)
- Changes in ICRS Cartilage Repair Assessment(week 0 and 48)
- Changes in 100 mm-VAS(Week 0, 24 and 48)
- Changes in IKDC Subjective Knee Evaluation(Week 0 and 24)
- Proportion of Patients Use of Rescue Medication(Week 12, 24 and 48)