Treatment of Long Bone Nonunion With Autologous Bone Marrow Stem Cells. Phase I/II Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Absence of adverse effects during timeframe as infections or complications related with the intervention
研究概览
简要总结
The aim of the study is to determine the safety and feasibility of autologous mononuclear stem cells in long bone nonunion; and moreover, to evaluate the efficacy of the treatment.
详细描述
In this study the investigators examine the improvement of conventional surgical treatment of long bone nonunion with the administration of bone marrow stem cells in order to achieve a higher percentage of healing and tissue reparation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed long bone nonunion
- •age from 18 years old
排除标准
- •active infection
- •cancer patients
- •concomitant serious illness
- •pregnant women
- •evidences of mental illness
- •previous alcohol or drug dependences
- •previous malignant disease during last 5 years, except for basal carcinoma
结局指标
主要结局
Absence of adverse effects during timeframe as infections or complications related with the intervention
时间窗: Six months
The proposed trial will involve the recruitment of a total of 30 patients. The cells will be collected via bone marrow sampling. The aspirate will be centrifuged on a Ficoll density gradient to isolate mononuclear cells, wich will be resuspended in heparinized isotonic saline and used in order to infuse into the area surgically treated. The surgical intervention means the introduction of a sheet with nails according with the usually employed technique.
次要结局
- Improvement and union of the bone(One year)