Evaluation the Side Effect of Bone Marrow Derived Mesenchymal Stem Cell in Patients With Osteoarthritis of Hip Joint
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
- swelling of hip joint
研究概览
简要总结
Osteoarthritis of the hip is a common type of osteoarthritis which can cause significant problems. First-line of management for patient with osteoarthritis consists of weight reduction, education, and analgesic medication. If necessary, invasive treatment like total hip replacement are performed for the patient. The objective of this study was to assess the safety of bone marrow mesenchymal stem cells (BM-MSCs) implantation in patients with hip osteoarthritis
详细描述
This is a phase one clinical study designed to investigate the safety of intra-articular injection of cultured autologous BM-MSCs in patients with severe hip osteoarthritis candidate for total hip replacement. All subjects will undergo bone marrow aspiration. Autologous MSCs will be extracted and cultured for 4 weeks. Patients will receive intra-articular injection of cultured MSCs under the guide of fluoroscopy. Paraclinical studies (X-Ray and MRI) will be done before and 6 months after treatment. Pain relief and functional improvement of the joint will be assessed by VAS, WOMAC, and Harris Hip Score questionnaire before treatment, and 2 and 6 months after treatment.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Osteoarthritis diagnosed by MRI
- •End stage osteoarthritis candidate for total hip replacement
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
swelling of hip joint
时间窗: 2 months
Evaluatin the swelling of hip joint by physical examination after intra articular injection.
deterioration of joint function
时间窗: 2 months
Evaluation deterioration of joint function by physical examination after intra articular cell injection.
skin allergic reaction
时间窗: 1 week
Evaluation the skin allergic reaction like erythema,rash,swelling after intra articular cell injection.
Respiratory reaction
时间窗: 1 week
Evaluation the Respiratory reaction like dyspenea by physical examination after imtra articular 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)