NCT01626625Unknown1 期
Mesenchymal Stem Cells; Donor and Role in Management and Reconstruction of Nonunion Fracture
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- healing of fracture
研究概览
简要总结
The investigators hypothesized that mesenchymal stem cells can be isolated from fracture site, iliac crest, and tibial crest, and can be expanded to be used in the management of nonunion fracture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •athropic nonunion fracture of the long bone
排除标准
- •immunocompromise,
- •active infection,
- •pathological fracture,
- •ongoing hormonal therapy
研究组 & 干预措施
stem cells
Experimental
stem cells + hydroxy apatite
干预措施: stem cells + hydroxy apatite (Drug)
autograft
Active Comparator
干预措施: autograft taken from iliac crest (Other)
结局指标
主要结局
healing of fracture
时间窗: 1 year
radiological union
次要结局
- VAS(1 year)
研究者
Ismail Hadisoebroto Dilogo
PhD
Indonesia University
研究点 (1)
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