JPRN-jRCT2033210138暂停2 期
Phase II Exploratory Study of EVA-001 for Osteoarthritis of the Knee - Phase II Exploratory Study of EVA-001 for Osteoarthritis of the Knee
Yamamoto Masao0 个研究点目标入组 50 人开始时间: 2021年6月9日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 80age old（—）
- 性别
- All
入选标准
- •Patients who meet all of the following criteria will be included.
- •1)Men and women between the ages of 20 and less than 80 years
- •2)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.
- •3)Patients with a K and L Grade of 2 to 4 based on simple x-ray examination
- •4)Patients with an area of lesion damage of 2-9 cm2 that is the primary source of clinical symptoms
- •5)Patients with knee flexion contractures of 10 degrees or less
- •6)Patients who are eligible for high tibial osteotomy with a femoro-tibial angle (FTA) of 180 to 185 degrees.
- •7)Patients with pain of 40 mm or more on the 100 mm VAS Scale
- •8)Patients with a BMI of 35 kg/m2 or less
- •9)Patients who do not wish to become pregnant during the trial period
- •10)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
- •1)no remaining lateral cartilage due to progressive osteoarthritis of the knee
- •2)autoimmune diseases or a history of such diseases
- •3)an infection or suspected infection requiring parenteral antibiotics
- •4)serious cardiovascular disease (myocardial infarction, congestive heart failure, uncontrolled hypertension, or other serious cardiac disease) or a history of such disease
- •5)gout or suspected gout
- •6)blood clotting abnormalities
- •7)serious renal function abnormalities
- •8)serious liver damage
- •9)serious medical conditions
- •10)malignancy or suspected malignancy
- •11)who are pregnant or potentially pregnant
- •12)who are currently breastfeeding
- •13)mental disorders or a history of mental disorders
- •14)who are habitual drinkers and are dependent or suspected of being alcoholic
- •15)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.
- •16)chronic inflammatory joint diseases (e.g., rheumatoid arthritis).
- •17)who have received immunosuppressive drugs such as cyclosporine A or azathioprine within the past 6 weeks
- •18)ligament fiber damage of Grade II or greater.
- •19)paralysis due to nerve or muscle disease on the side of the knee joint cartilage damage or defect (affected side of the leg)
- •20)a history of serious hypersensitivity to bovine-derived or porcine derived ingredients of this product
- •21)a history of severe hypersensitivity or anaphylactic shock to gentamicin
- •22)a history of severe hypersensitivity or anaphylactic shock to metal allergy
- •23)a history of severe hypersensitivity or anaphylaxis to sodium hyaluronate or products containing hyaluronic acid.
- •24)a history of blood transfusion or transplantation
- •25)who have participated in another clinical trial within the past 3 months
- •26)who have been at rest for a long period of time within the past 3 months
- •27) with a history of contraindications to magnetic resonance imaging (MRI) or contrast media
- •28) with meniscus locking symptoms
- •29) Other patients who are determined to be unsuitable by the investigator or sub-investigator
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