EUCTR2014-000510-59-DK进行中(未招募)1 期
Fat transplantation enriched with ex vivo expanded adipose-derived autologous mesenchymal stem cells in reconstruction of the breast.
Dept of Plastic Surgery, Breast Surgery & Burns0 个研究点目标入组 14 人开始时间: 2014年6月30日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 14
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1.Age 30 - years (incl. 30 and 45)
- •2.Healthy females
- •3.BMI 22 - 30 kg/m2 (incl. 20 and 30)
- •4.1500 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs
- •5.Desire for breast augmentation with 300 ml in each breast
- •6.Symmetric breast hypoplasia
- •7.Speaks and reads Danish
- •8.Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 14
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •2.Previous abdominal surgery or breast surgery
- •3.Previous cancer or known breast cancer predisposition
- •4.Pregnancy or planned pregnancy within one year after the procedure
- •5.Breastfeeding less than 6 months prior to inclusion
- •6.Known chronic disease
- •7.Pacemaker or other implanted foreign objects
- •8.Allergy towards necessary anaesthesia
- •9.Current or previous participation in other medical studies
- •10.Withdrawal of informed consent
研究者
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