NCT00250302已完成1 期
Autologous Implantation of Mesenchymal Stem Cells for the Treatment of Distal Tibial Fractures
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Safety
研究概览
简要总结
Mesenchymal stem cells are found in bone marrow, and have the ability to differentiate into different tissue types. The primary objective of the study is to examine the safety of using such cells to treat patients suffering from distal tibial shaft fractures. The cells will be isolated from the patient's bone marrow, loaded onto a carrier and implanted locally at the fracture site.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ages 18 and
- •males not involved in active military duty. females- non child bearing potential. distal tibia third fracture without joint involvement. fracture treated by IM nail, percutaneous plating or external fixation.
排除标准
- •active systemic or local infection. history of malignancy radiotherapy or chemotherapy. active autoimmune disease. any past or present immunosuppressive treatment. fracture treated by open reduction. fracture grade gustillo grade IIIB, IIC. use of steroids in past 6 months. chronic renal insufficiency. administration of marrow suppressive drugs. history of metabolic bone disease. administration of drugs that may interfere with bone metabolism.
结局指标
主要结局
Safety
Number of patients reaching clinical union of fracture
次要结局
未报告次要终点
研究者
研究点 (1)
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