jRCT2063210037已完成不适用
Investigator-initiated Clinical Trial to Evaluate the Safety and Efficacy of Magnetic targeting using Autologous Bone Marrow-derived Mesenchymal Stem Cell (m-MSC) in Knee Osteoarthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 主要终点
- Incidence rate of adverse events (%)
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
- Single Arm Study
- 干预模型
- Single 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 under（—）
- 性别
- All
入选标准
- •Patients whose age is between 20 and 80 years old at the time of obtaining consent
- •Patients whose written consent has been obtained
- •Patients who have been diagnosed with knee osteoarthritis
- •Patients with Kellgren-Lawrence classification grade 2 or 3 osteoarthritis on X-ray examination
- •Patients whose articular cartilage damage is limited to the medial condyle or lateral condyle
- •Patients who have received conservative treatment, including exercise therapy, for at least 3 months from the time of enrollment
- •Patients with clinical symptoms of pain in the knee
排除标准
- •Patients who have undergone reconstruction of the anterior cruciate ligament and/or posterior cruciate ligament within 2 months of enrollment in the study
- •Patients scheduled for treatment of meniscus injury or patients who have undergone surgery for meniscus injury within 6 months of enrollment in the study
- •Patients with knee deformity inward or outward more than 10 degrees from the normal value (FTA 175 degrees)
- •Patients with implanted medical devices that may be affected by magnetic fields
- •Patients with malignant tumors, suspected malignant tumors, or with a history of malignant tumors within 5 years
- •Patients who are pregnant or may be pregnant, who are breast-feeding, or who wish to become pregnant during this study
- •Patients with psychiatric disorders
- •Patients with a history of hypersensitivity to ferucarbotran components or iron injection
- •Patients with iron overload such as hemochromatosis
- •Patients with active bleeding
- •Patients with allergy to animals (bovine or porcine)
- •Patients with hypersensitivity to gentamicin or amphotericin B, and patients with a history of hypersensitivity to aminoglycoside antibiotics
- •Patients who are positive for beef allergy test
- •Patients who are positive for any of the following tests; HBs antigen test, HCV antibody test, or HIV antibody test
- •Other patients who are judged by the investigator or sub-investigator to be inappropriate to participate in this study
结局指标
主要结局
Incidence rate of adverse events (%)
不良事件发生率（%）
Incidence rate of defects (%)
缺陷发生率（%）
Confirmation of the occurrence of significant adverse events
确认发生重大不良事件（肿瘤性病变、过敏症状和未知感染，这些事件与再生医疗产品的特定风险之间的因果关系无法否认）
次要结局
- Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) score
- International Cartilage Repair Society (ICRS) score
- Histological evaluation
研究者
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