jRCT2033210138暂停不适用
Phase II Exploratory Study of EVA-001 for Osteoarthritis of the Knee (Phase II Exploratory Study of EVA-001 for Osteoarthritis of the Knee)
EVASTEM Co., Ltd.0 个研究点目标入组 50 人开始时间: 2020年6月29日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 50
- 主要终点
- Efficacy
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 80age old not（—）
- 性别
- All
入选标准
- •Patients who meet all of the following criteria will be included.
- •Men and women between the ages of 20 and less than 80 years
- •Patients with ICRS Grade 3 or 4 cartilage damage or deficiency in the knee joint as determined by magnetic resonance imaging (MRI) during the screening phase or by examination within the past 3 months.
- •Patients with a K and L Grade of 2 to 4 based on simple x-ray examination
- •Patients with an area of lesion damage of 2-9 cm2 that is the primary source of clinical symptoms
- •Patients with knee flexion contractures of 10 degrees or less
- •Patients who are eligible for high tibial osteotomy with a femoro-tibial angle (FTA) of 180 to 185 degrees.
- •Patients with pain of 40 mm or more on the 100 mm VAS Scale
- •Patients with a BMI of 35 kg/m2 or less
- •Patients who do not wish to become pregnant during the trial period
- •Patients who have voluntarily decided to participate in the trial and have signed the consent form.
排除标准
- •Patients who meet any of the following criteria shall be excluded
- •no remaining lateral cartilage due to progressive osteoarthritis of the knee
- •autoimmune diseases or a history of such diseases
- •an infection or suspected infection requiring parenteral antibiotics
- •serious cardiovascular disease (myocardial infarction, congestive heart failure, uncontrolled hypertension, or other serious cardiac disease) or a history of such disease
- •gout or suspected gout
- •blood clotting abnormalities
- •serious renal function abnormalities
- •serious liver damage
- •serious medical conditions
- •malignancy or suspected malignancy
- •who are pregnant or potentially pregnant
- •who are currently breastfeeding
- •mental disorders or a history of mental disorders
- •who are habitual drinkers and are dependent or suspected of being alcoholic
- •a mean number of cigarettes smoked per day x number of years of smoking to date of 200 or more, and patients who are nicotine dependent or suspected to be so.
- •chronic inflammatory joint diseases (e.g., rheumatoid arthritis).
- •who have received immunosuppressive drugs such as cyclosporine A or azathioprine within the past 6 weeks
- •ligament fiber damage of Grade II or greater.
- •paralysis due to nerve or muscle disease on the side of the knee joint cartilage damage or defect (affected side of the leg)
- •a history of serious hypersensitivity to bovine-derived or porcine derived ingredients of this product
- •a history of severe hypersensitivity or anaphylactic shock to gentamicin
- •a history of severe hypersensitivity or anaphylactic shock to metal allergy
- •a history of severe hypersensitivity or anaphylaxis to sodium hyaluronate or products containing hyaluronic acid.
- •a history of blood transfusion or transplantation
- •who have participated in another clinical trial within the past 3 months
- •who have been at rest for a long period of time within the past 3 months
- •with a history of contraindications to magnetic resonance imaging (MRI) or contrast media
- •with meniscus locking symptoms
- •Other patients who are determined to be unsuitable by the investigator or sub-investigator
结局指标
主要结局
Efficacy
时间窗: 52 weeks post-treatment
Percentage of improvement in ICRS grade 1 or better
次要结局
- Change in WOMAC Scale total score(52 weeks post-treatment)
- Change in KOOS Scale total score(52 weeks post-treatment)
- Total ICRS points(52 weeks post-treatment)
- Evaluation of cartilage regeneration(52 weeks post-treatment)
- Improvement in pain score by VAS Scale(up to 52 weeks post-treatment)
- Classification of cartilage shape by MRI(up to 52 weeks post-treatment)
- Improvement in K&L grade by X-ray(up to 52 weeks post-treatment)
- Improvement in IKDC score(up to 52 weeks post-treatment)
研究者
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