Phase I Study of Human Umbilical Cord Mesenchymal Stem Cell Implantation in the Treatment of Articular Cartilage Defect of Knee
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Severity of adverse events
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for articular cartilage defect of knee.
详细描述
Human articular cartilage has limited repair potential.Cell-based strategies have explored chondrocytes and mesenchymal stem cells (MSCs) with extensive basic science and preclinical studies.However the concept of autologous chondrocyte implantation is not ideal,so the focus in cartilage repair is shifting toward mesenchymal stem cells.
To investigate the effects of hUC-MSC treatment for articular cartilage defects, 20 patients will be enrolled and receive 4 times of hUC-MSC transplantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must consent in writing to participate in the study by signing and dating an informed consent document
- •Healthy patients with no major history of illness
- •Patients must have a diagnosis of osteoarthritis by radiographic criteria of Kellgren and Lawrence grade 2-4
- •Patients who needs invasive interventions of arthroplasty due to no response from existing pain medication
- •Patients must have had more than Grade 4 (0~10 point numeric scale) pain at least for four months
- •Patient's damaged cartilage area should be in the range of 2-6cm2
排除标准
- •Pregnant women or lactating mothers
- •Patients who have received any anti-inflammatory drugs including herb-drug within 14 days
- •Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment
- •Patients with positive human immunodeficiency (HIV) at screening indicative of current of pass infection
- •Impaired liver function, abnormal blood coagulation, combine other tumor or special condition
- •Patients who had participated in other clinical trials within three months prior to this study
结局指标
主要结局
Severity of adverse events
时间窗: 12 months
Adverse events were categorized using National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.0 scale (NCI-CTCAE v4.0).
次要结局
- Magnetic resonance imaging (MRI) of the knee(Before and 1,3,6,12 month after treatment)
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Before and 1,3,6,12 month after treatment)