Examining the Best Solution for Dermal and Subcutaneous Augmentation and Regeneration Using Ex-vivo Expanded Autologous Adipose-derived Stromal Cells, Autologous Fat Tissue and Natural Tissue Scaffolds
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 5
- 试验地点
- 4
- 主要终点
- Volume assessment
研究概览
简要总结
Investigate the effect of dermal/subcutaneous injection of ASC enriched fat transplant in a protective natural scaffold, designed to sustain the ASC viability after dermal/subcutaneous injection.
详细描述
The study investigates the effect of different concentrations of autologous ex-vivo expanded adipose-derived stromal cells (ASCs), fat and a natural scaffold for skin rejuvenation and augmentation. The aim is to better the volume of fat grafts for cosmetic and reconstructive purposes. Fat is a near ideal filler, as it is biocompatible. However the retention rate of fat grafts often result in poor outcomes and it is unpredictable. The investigators have set up an experimental study in which participants with excess abdominal skin is recruited. They will have injections with 11 different solutions of fat, ACSs, scaffold and dermal CO2 laser in the abdominal skin. After 3 months biopsies will be taken and after 6 months all of the treated area will be removed by an cosmetic abdominoplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 18-30 kg/m2
- •400 mL of fat (lipoaspirate) available for liposuction in the thighs or back
- •Desire for abdominoplasty
- •Speaks and reads Danish
- •Signed informed consent
排除标准
- •Previous major abdominal surgery
- •Previous cancer or predisposition to cancer
- •Pregnancy or planned pregnancy
- •Known chronic disease associated with metabolic malfunction or poor healing
- •Pacemaker
- •Allergy to necessary anaesthesia
- •Intention of significant weight loss or weight gain within the trial period
结局指标
主要结局
Volume assessment
时间窗: Baseline, three months, Six months
CT scan
次要结局
- Cell count, immunohistochemistry, skin quality(Three months, six months)
- Immunohistochemistry(Three months, six months)
- Skin thickness(Three months, six months)