Osseous Setting Improvement With Co-implantation of Osseous Matrix and Mesenchymal Progenitors Cells From Autologous Bone Marrow
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 50
- 主要终点
- Evaluate osseous setting at 3-months follow-up and compare our results with past studies
研究概览
简要总结
Sometime osseous reconstruction needs allogeneic bone, in this study we use Ostéopure™ from Ostéobanque d'Auvergne, which is a osseous matrix. However Ostéopure™ integration lasts a long time. To optimize this integration we purpose to associate mesenchymal progenitors cells from autologous bone marrow.
详细描述
All patients will be treated for tibia or femur pseudo-arthrosis. At the beginning of chirurgical intervention, autologous bone marrow will be sampling and will be concentrated during this one.
Meanwhile osseous matrix (Ostéopure™ ) will be incubated in autologous blood serum and finally implanted in the fracture site. And after (at the end of chirurgical intervention), concentrate autologous bone marrow will be injected in the same place.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •tibia or femur pseudo-arthrosis,
- •patient who needs bone graft
排除标准
- •- contra indications for chirurgical intervention or bone graft
结局指标
主要结局
Evaluate osseous setting at 3-months follow-up and compare our results with past studies
时间窗: at 3-months follow-up
次要结局
- Feasibility and tolerance of this therapeutic strategy(at 3-months follow-up)