KCT0001619进行中（未招募）未知
Multicenter Randomized, Double-Blind, Placebo Controlled Phase IIb/III Clinical Trial to Evaluate Efficacy and Safety of Jointstem in patients with Degenerative Arthritis
R-bio0 个研究点目标入组 24 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1) Age 18 or older, male and female
- •2) Patients must consent in writing to participate in the study by signing and dating an informed consent document
- •3) Diagnosis of osteoarthritis by ACR(American College of Rheumatology Criteria) osteoarthritis of the knee
- •4) Diagnosis of osteoarthritis by radiographic criteria of Kellgren and Lawrence grade 2-4
- •5) More than Grade 4 (0~10 point numeric scale) pain at least for 12 weeks
- •6) Diagnosis of osteoarthritis of class ?~? by ACR(American College of Rheumatology Criteria) Global functional criteria
- •7) Patient who agree with contraception
排除标准
- •1) Preparing for Pregnancy or Pregnant women or lactating mothers.
- •2) Patients with Body Mass Index (BMI) > 35.
- •3) Patients with other disease including
- •: Septic arthritis, Rheumatoidal or Inflammatory joint disease, Crystalline disease (gout or pseudogout), Paget disease, Articular fractures, Ochronosis, Acromegaly, Hemochromatosis, Wilson's disease, Osteochondromatosis, Hereditary disorder
- •4) Patients with serious condition internal medicine disease
- •5) Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C (HCV), syphilis at screening
- •indicative of current of pass infection.
- •6) Patient with behavioral disorders, cognitive disorders and chronic mental symptoms
- •7) Patient with significant neurologic or psychiatric disorders
- •8) Patients who aclcohol, drug abuse history
- •9) Patients who had participated in other clinical trials within 12 weeks prior to this study.
- •10) Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment.
- •11) Patients who experienced as the knee joint cartilage and stem cell therapy
- •12) Patients who the principal investigator considers inappropriate for the clinical trial due to any other reasons than those listed above
- •13) Patients who penicillin hypersensitivity reactions
研究者
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