Treatment of Nonunion of Limb Fracture With Human Amniotic Epithelial Cells（hAECs）
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- time for bone union
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of human amniotic epithelial cells transplant in nonunion of limb fracture patients.
详细描述
In this study, patients of nonunion after limb fracture will be treated with human amniotic epithelial cells. Clinical and radiological assessment is performed.
hAECs developing from the epiblast as early as 8 days after fertilization, recent data reported indicate that hAECs possess proper osteogenic differentiation potential and a localized modulatory influence on the early tissue remodeling process, making these cells a promising stem cell source for bone regeneration after fractures.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with nonunion of limbs by x-ray and bone scan;
- •compliance to treatment and long term follow-up;
- •be able and willing to participate in the study;
- •written informed consent before study.
排除标准
- •pregnant or breastfeeding;
- •patients with malignancy, immunocompromised ( HIV AIDS, Diabetes mellitus, active Hepatitis), in a immunosuppressant therapy ( chemotherapy or steroids), OR health status, mental diseases, which will influence the study;
- •patients undergoing any other treatment that are not related to this study;
- •others considered not appropriate selected patients.
结局指标
主要结局
time for bone union
时间窗: 6 months
Bone union was evaluated at 6-month after surgery according to the following definition.Definition of bone union is when simple X-ray findings reveal that bone trabeculae or cortical bone exceeds the fracture site.
次要结局
- limb functional score(1 year)
- pain in fracture site(1 year)