NCT02803177已完成2 期
BMC2012, Cell Based Therapy by Implanted Bone Marrow-derived Mononuclear Cells (BMC) for Bone Augmentation of Plate-stabilized Proximal Humeral Fractures - a Randomized, Open, Multicentric Study - Phase IIa
Goethe University2 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2016年7月2日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Secondary dislocation of fracture
研究概览
简要总结
In the present phase-II clinical trial the researchers investigate efficacy and proof of concept of the augmentation with preoperatively isolated autologous BMC cells seeded onto ß-TCP in combination with an angle stable fixation (Philos plate®) for the therapy of proximal humeral fractures.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged between
- •years with proximal humerus fractures
- •indication for open reposition and internal stabilisation with a proximal fixed- angle plate for humerus (PHILOS, Synthes, Oberdorf, Swiss):
- •2-, 3- or 4-fragment fracture according to Neer
- •dislocation of >10 mm between fragments and/or
- •angle of > 45° between fragments and/or
- •dislocation of tuberculum majus > 5 mm
- •negative pregnancy test of premenopausal women
- •signed informed consent for surgery and participation in the clinical trial
排除标准
- •contraindications against administration of Investigational medicinal product (IMP) is pregnancy and nursing
- •dislocation fracture
- •known psychic disorder that leads to incompliance (e.g. dementia, schizophrenia, major depression)
- •pathologic fractures caused by other underlying diseases
- •fracture-induced nerve damage
- •tumor disease with recent adjuvant therapy or treatment during the last 3 months (e.g. chemotherapy, radiotherapy), untreated tumor diseases
- •known hypersensibility against components of the transplant
- •participation in a clinical trial during the last 3 months prior to this study
结局指标
主要结局
Secondary dislocation of fracture
时间窗: 12 weeks
Secondary dislocation is diagnosed on plain radiographs, if more than 20° varus collapse of the humeral head fragment in relation to the humeral shaft and / or screw penetration through the humeral head is detected
次要结局
- Functional outcome after fixation(12 weeks)
研究者
Ingo Marzi, MD Prof.
head physician
Goethe University
研究点 (2)
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