Study of Autologous Stromal Vascular Fraction From Adipose Tissue in Promoting Skin Regeneration
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Measure the texture changes of the skin
研究概览
简要总结
The purpose of this study is to observe whether the transplantation of autologous stromal vascular fraction (SVF) in adipose tissue is safe and its effect on improving skin regeneration.
详细描述
This is a randomized controlled single blind clinal trial that designed to observe whether the transplantation of autologous stromal vascular fraction (SVF) in adipose tissue is safe and its effect on improving skin regeneration.
The clinical trial will concentrate on the therapeutic effect of SVF after facial injection. After 1, 4, 8, 12, 24 and 48 weeks of treatment, a comprehensive examination of the facial skin was performed to assess the effect of the SVF. Skin texture, thickness and colour will be observed to evaluate the effect of SVF on skin regeneration
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of 18 to
- •No other facial plastic surgery or cosmetic surgery was performed during the study period (frontal, temporal, and lower eyelid).
- •Intends to undergo facial anti-aging treatment with SVF
排除标准
- •Not fit for stem cells graft treatment.
- •Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for SVF treatment; or history of delayed healing, radiational therapy.
- •Significant renal, cardiovascular, hepatic and psychiatric diseases.
- •Significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV).
- •Used external medication on the targeting area within 4 weeks.
- •Skin invasive treatment including laser on the targeting area within 6 months.
- •Hyaluronic acid injection on the targeting area within 12 months.
- •Botulinum toxin injection on the targeting area within 6 months.
- •History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis.
- •Evidence of malignant diseases or unwillingness to participate.
研究组 & 干预措施
stromal vascular fraction
Transplantation of resuspended SVF
干预措施: stromal vascular fraction (Biological)
saline
1 ml saline without cells will be used as placebo.
干预措施: Saline (Drug)
结局指标
主要结局
Measure the texture changes of the skin
时间窗: Baseline and 12 months post the treatment
Using Cutometer® dual MPA 580 in 12 months post the treatment.
次要结局
- Measure the colour changes of the skin(Baseline and 12 months post the treatment)
- Occurence of major adverse events(Up to approximately 12 months after study start)
研究者
Qing-FengLi Li,MD
MD, PhD, Professor, Head of Departement of Plastic and Reconstructive Surgery, Shanghai 9th People's Hospital
Shanghai Jiao Tong University School of Medicine