跳至主要内容
临床试验/EUCTR2014-000510-59-DK
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

发起方
Dept of Plastic Surgery, Breast Surgery & Burns

相似试验