Evaluation the Side Effects of Autologous Chondrocyte Intra-articular Implantation in Patients With Severe Hip Osteoarthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- joint swelling
研究概览
简要总结
Hip osteoarthritis is degeneration of hip cartilage and inflammation of subchondral bone and soft tissue linings. Patients have pain, stiffness, swelling, and difficulty walking. There are treatments available to help manage these symptoms like weight loss, and analgesics. Surgery is the appropriate treatment in patients who have failed these conservative treatments. The aim of this clinical study is to assess safety of autologous cultured chondrocyte intra-articular injection and obtain its clinical results in patients with severe hip osteoarthritis.
详细描述
In this phase I clinical study 6 patients with severe hip osteoarthritis will be recruited. All patients will have a cartilage biopsy taken from the knee cartilage non-weight bearing zone. Chodrocytes will be extracted and cultured for 4 weeks. Patients then will receive chondrocyte injection under the guide of fluoroscopy. Patients will be evaluated post injection for 6 months at time intervals. Parameters considered being evaluated are, adverse effects, pain intensity and joint physical function and cartilage repair. These effects are measured by Visual Analogue Scale, WOMAC, Harris Hip Score questionnaire and MRI.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis diagnosed by MRI
排除标准
- •Pregnancy or lactating
- •Positive tests for HIV, HCV, HBV
- •Active neurologic disorder
- •End organ damage
- •Uncontrolled endocrine disorder.
结局指标
主要结局
joint swelling
时间窗: 2 months
Evaluation the swelling of hip joint after cell injection by physical examination.
deterioration of joint function
时间窗: 2 months
evaluation the deterioration of joint function by physical examination 2 months after injection in compare with base line(before injection)
dispenea
时间窗: 1 week
Evaluation the respiratory allergic reactions like dispenea by physical examination after cell injection.
skin rash
时间窗: 1 week
Evaluation the skin allergic reactions like skin rash by physical examination after cell injection.
次要结局
- Quantitative changes in pain intensity(2 months)
- physical function improvement(2 months)
- subchondral bone edema(2 months)
- cartilage thickness(2 months)