Autologous Stem Cell Therapy for Fracture Non-union Healing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Radiological assessment of new callus and fracture bridging
研究概览
简要总结
Do mesenchymal stem cells accelerate new bone formation in persistent non-unions.
详细描述
Do mesenchymal stem cells accelerate new bone formation in persistent non-unions treated with carrier plus in vitro expanded autologous BMSCs or carrier alone (control). Secondary aims were to analyze predictors of union in these patients and describe adverse events at final follow-up.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An established non-union according to the US Food & Drug Administration criteria
- •Non-union following fracture of tibia or femur suitable for synthetic bone grafting.
排除标准
- •Skeletal immaturity.
- •Pregnant or breast-feeding.
- •Non-union following pathological fractures.
- •Positive to Hepatitis B, Hepatitis-C or HIV.
- •Infection during BMSC culture.
结局指标
主要结局
Radiological assessment of new callus and fracture bridging
时间窗: 12 months
The primary outcome measure was formation of new callus and cortical bridging, assessed from pre-operative and multiple post-operative radiographs and CT-scans up to 12 months. These images were divided into early (0-3 months) and late (9-12 months) groups. Non-unions were assessed from anonymized slides by four independent reviewers (two radiologists and two orthopedic surgeons) blinded to the side of cell insertion. Each slide had a pre-operative radiograph for comparison but no indication of time since surgery, and showed a medial/ lateral or an anterior/ posterior view depending on the surgical approach . At first, each reviewer indicated the side with largest callus and most cortical bridging pre-operatively. Then each reviewer examined subsequent radiographs to indicate the side with the largest increase in new callus and cortical bridging.
次要结局
- EQ-5D(12 months)