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临床试验/jRCT2033210138
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:
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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
研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

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

发起方
EVASTEM Co., Ltd.

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