NCT03678467Unknown1 期
An Open-Label, First-in-Human, Single Intervention Study for Evaluation of EpiBone-CMF Engineered Living Bone Graft for Mandibular Ramus Reconstruction
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 6
- 试验地点
- 6
- 主要终点
- Number of participants with treatment-related adverse events
研究概览
简要总结
EpiBone-Craniomaxillofacial (EB-CMF) is an autologous, anatomically shaped bone graft created specifically for the patient's defect, using the patients own adipose-derived mesenchymal stem cells. This first in human trial is designed specifically to assess the safety of EB-CMF clinically. Although secondary measures of graft efficacy are being assessed, the primary focus will be on Adverse Events stemming from graft implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Number of participants with treatment-related adverse events
时间窗: 12 months
To assess the safety of EB-CMF for up to 12 months post surgery in subjects with recent or remote mandibular ramus defects requiring up to a 15 cc graft reconstruction.
次要结局
- Bone regeneration as assessed by high-resolution CT scans(12 months)
- Quality of life as measured by the Glasgow Benefit Inventory(12 months)
- Quality of life as measured by SF-12(12 months)
研究者
研究点 (6)
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