The Study of Early Stage Osteonecrosis of Femoral Head With Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSC)
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- MRI imageological examination
研究概览
简要总结
The purposes of the study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating osteonecrosis of femoral head patients.
详细描述
This is a randomized,double-blind, paralleled study. Patients will be divided into two groups of experiment and control. All of them will receive core decompression of the femoral head, while experimental group patient will transplant hUC-MSC in addition. Follow-up visit will occur on 1 month, 3 months, and 6 months after operation, and Harris Hip score was applied to evaluate the symptoms change.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ficat classification is I, IIa, or IIb period
- •no obvious improvement or ingravescence by conservative treatment
- •patients or their statutory receive human umbilical cord mesenchymal stem cell of their own will, and signed informed consent form
排除标准
- •Ficat classification is third or fourth period
- •acute, chronic infection patients
- •combined with heart, lung, kidney disease, and cannot tolerate operation
- •ankylosing spondylitis patient
- •acetabular dysplasia patient
- •with tumor
- •clinical data deficient
- •HIV positive
- •pregnancy or breast feeding women
- •under other therapy that possibly influence MSC security or efficacy
研究组 & 干预措施
Group 1
Core decompression surgery; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#).
干预措施: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) (Drug)
Group 1
Core decompression surgery; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#).
干预措施: core decompression (Procedure)
Group 2
Core decompression surgery.
干预措施: core decompression (Procedure)
结局指标
主要结局
MRI imageological examination
时间窗: 6 months
MRI imageological examination to evaluate the efficient of mesenchymal stem cells.
次要结局
- Harris Hip Score(6 months)