NL-OMON41222撤回3 期
A pivotal Phase IIb/III, multicentre, randomised, open, controlled study on the efficacy and safety of autologous osteoblastic cells (PREOB®) implantation in non-infected hypotrophic non-union fractures - PREOB-NU3
Bone Therapeutics S.A.0 个研究点目标入组 34 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 34
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Men and women, aged between 18 and 65 years old
- •Diagnosed with non-infected hypotrophic non-union fractures as confirmed by X-ray
排除标准
- •Fracture interline > 1 cm
- •Open fracture with septic local infection
- •Insufficient fracture stability
- •Osteosynthesis material other than intramedullary nails, scews, plates or external fixation
- •Bone infection
- •Multifocal fracture / non-union
- •Non-union or non-consolidated fracture on the neighbouring bone
- •Nerve damages or tendon lesion at the non-union fracture site
研究者
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