jRCT2033210646进行中（未招募）不适用
Phase-III Comparative Study of EVA-001 for Osteoarthritis of the Knee
MEDIPOST K.K.0 个研究点目标入组 130 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 130
- 主要终点
- Change from baseline in the WOMAC scale
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 a K&L Grade of 2 to 3 based on simple X-ray examination
- •Patients with ICRS Grade 3 or 4 cartilage damage or deficiency in the knee joint (Determined by magnetic resonance imaging (MRI) or by examination within the past 3 months)
- •Patients with lesions of 2-9 cm2 that are the main cause of clinical symptoms
- •(MRI evaluation during the screening phase and Arthroscopy at Visit 3 by Principal Investigator or Sub-Investigator)
- •Patients with FTA greater than 174 degrees and less than 180 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 have not responded to conservative therapy for more than 3 months
- •For women of childbearing potential, patients who agree to maintain contraceptive status for the duration of the study
- •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.
- •Patients with autoimmune diseases or a history of autoimmune diseases
- •Patients with infections requiring parenteral antibiotics or suspected of having such infections
- •Patients with serious cardiovascular disease (myocardial infarction, congestive heart failure, uncontrolled hypertension, or other serious cardiac disease) or a history of such disease
- •Patients with gout or suspected gout
- •Patients with blood clotting abnormalities
- •Patients with serious renal function abnormalities
- •Patients with serious liver damage
- •Patients with serious medical conditions
- •Patients with malignancy or suspected malignancy
- •Patients who are pregnant or currently breastfeeding
- •Patients who have received intra-articular drugs such as hyaluronic acid injections within the past 8 weeks
- •Patients with mental disorders or a history of mental disorders
- •Patients who are habitual drinkers and are dependent or suspected of being alcoholic
- •Patients with nicotine dependence or suspected nicotine dependence
- •Patients with chronic inflammatory joint diseases (e.g., rheumatoid arthritis)
- •Patients who have received immunosuppressive drugs such as cyclosporine A or azathioprine within the past 6 weeks
- •Patients with dynamic injuries to the anterior cruciate ligament, posterior cruciate ligament, medial collateral ligament, and lateral collateral ligament of the knee
- •Patients who are scheduled to undergo surgical treatment of the target knee joint, such as treatment for meniscus injury or ligament reconstruction, or who have undergone such surgical treatment within the past 6 months.
- •Patients with paralysis due to nerve or muscle disease on the side of the knee joint cartilage damage or defect (affected side of the leg)
- •Patients with a partial arthroplasty in the knee to be transplanted.
- •Patients with a history of serious hypersensitivity to bovine-derived or porcine-derived ingredients of this product
- •Patients with a history of severe hypersensitivity or anaphylactic shock to gentamicin
- •Patients with a history of severe hypersensitivity or anaphylaxis to sodium hyaluronate or products containing hyaluronate
- •Patients with a history of transplantation or multiple blood transfusion
- •Patients who have participated in another clinical trial within the past 3 month
- •Patients who have been at rest for a long period of time within the past 3 months
- •Patients with a history of contraindications for cartilage magnetic resonance imaging (MRI) or contrast media if contrast media is used.
- •Other patients deemed unfit by the (sub)investigator, taking into account the assessment of safety and efficacy (e.g. subjective judgement).
结局指标
主要结局
Change from baseline in the WOMAC scale
时间窗: 52 weeks post-treatment
Change from baseline in the WOMAC scale at 52 weeks post-treatment
Percentage of improvement in ICRS grade 1 or better
时间窗: 52 weeks post-treatment
Percentage of improvement in ICRS grade 1 or better at 52 weeks post-treatment
次要结局
- Total ICRS points(52 weeks post-treatment)
- Evaluation of cartilage regeneration(52 weeks post-treatment)
- Change from baseline in 100 mm VAS value(52 weeks post-treatment)
- Change from baseline in whole organ magnetic resonance imaging score (WORMS)(52 weeks post-treatment)
- Treatment Failure rate
- Change from baseline in IKDC score(52 weeks post-treatment)
- Change from baseline in each WOMAC subscale(52 weeks post-treatment)
- Change from baseline in KOOS scale(52 weeks post-treatment)
研究者
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