Fat Transplantation Enriched With Expanded Adipose-derived Autologous Mesenchymal Stromal Cells in Cosmetic Breast Augmentation and Cosmetic Facial Filling
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in volume over time after breast augmentation
研究概览
简要总结
The purpose of the present study is to examine whether enrichment of a fat graft with autologous ex vivo expanded ASC injected into the breast tissue or face, both for cosmetic use, will significantly improve the results of conventional lipofilling and synthetic facial fillers, thereby being able to offer a safer, more natural and long-lasting alternative to current artificial solutions for cosmetic patients.
详细描述
The cosmetic breast augmentation design is a double-blind (surgeon and data assessor) randomized, prospective clinical study on healthy subjects.
The cosmetic facial filling design is a data assessor-blinded, randomized, prospective clinical study on healthy subjects.
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
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Criteria breast augmentation:
- •Inclusion criteria
- •Age 18 - 50 years
- •Healthy females
- •BMI 18 - 30 kg/m2
- •1000 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs
- •Desire for breast augmentation
- •Speaks and reads Danish or English
- •Signed informed consent
排除标准
- •Previous breast surgery
- •Previous cancer or predisposition to breast cancer
- •Pregnancy or planned pregnancy within one year after the procedure
- •Breastfeeding less than 6 months prior to inclusion
- •Weight gain or loss above 2 BMI point
- •Known chronic disease associated with metabolism malfunction or pour healing
- •Pacemaker or other implanted foreign objects
- •Allergy towards necessary anaesthesia
- •Intention of weight loss or weight gain within the trial period
- •Criteria fascial filling
- •Inclusion criteria
- •Age 25 - 65 years
- •Healthy females
- •BMI 18 - 30 kg/m2
- •100 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs
- •Desire for facial wrinkle treatment and facial augmentation (rejuvenation)
- •Speaks and reads Danish or English
- •Signed informed consent
- •Exclusion criteria
- •Previous facial surgery
- •Previous cancer
- •Pregnancy or planned pregnancy within one year after the procedure
- •Known chronic disease associated with metabolism malfunction or poor healing
- •Allergy towards necessary anaesthesia
- •Intention of weight loss or weight gain within the trial period
结局指标
主要结局
Change in volume over time after breast augmentation
时间窗: Baseline, four and twelve months
Measurement of the residual volume of fat transplants as based on MRI before operation (baseline), and four and twelve months after lipo-injection to the breast in order to determine the difference in volume between baseline and 4 months and 12 months post operative; and thereby the resorption rate over time.
次要结局
- Change in cosmetic facial appearance over time after facial filling(Baseline, one, four and twelve months)