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临床试验/NCT03965936
NCT03965936已完成不适用

Effect of Adipose Derived Stem Cells on Survival of Fat as Filler

Alexandria University2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
15
试验地点
2
主要终点
Assessment using hollowness severity rating scale :0 : no visible hollowness, 1: mild Hollowness, 2 : moderate Hollowness, 3: severe Hollowness

研究概览

简要总结

this research is to study the effect of Adipose Derived Stem Cells on Survival of Fat as Filler

详细描述

Skin aging is a complex biological process.The physiological changes associated with aging of the skin are manifested in xerosis, dramatic loss of skin elasticity due to damage to collagen and elastin fibers; as well as barrier function, modification of rhytides and deficiencies in the regenerative property of the skin. All of which ultimately result in thinning of the skin, malar fat atrophy and pigmentary changes. Autologous fat grafting or lipo injection containing stromal vascular fraction (SVF) acts like ideal soft tissue filler for facial filling and rejuvenation. It leads to progressive improvement of the skin texture, elasticity, and color over a few months, therefore adipose tissue seems to be not only a simple filler but also a dynamic filler with two types of different and supplementary effects, the volumetric effect and the regenerative effect.Cell assisted lipotransfer (CAL) is a technique that combines aspirated fat with concentrated ADSCs in the stromal vascular fraction (SVF) of the lipoaspirate. This technique could enhance the survival rate of the transplanted fat and leads to better cosmetic improvement

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
None

入排标准

年龄范围
35 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • History of keloid formation.
  • Any coincidental chronic illness (e.g. metabolic, autoimmune or endocrinal) or malignancy.
  • Any bleeding or coagulation disorder or recent use of anticoagulant therapy.
  • Active infection.
  • History of any previous aesthetic procedure on the face within the past 6 months.
  • History of intake of anti-aging systemic or topical medications within the previous 3 months

研究组 & 干预措施

lipofilling

Placebo Comparator

subcutaneous injection of lipoaspiate (microfat) in one temporal region

干预措施: lipofilling (Procedure)

lipofilling enriched with adipose tissue derived stem cells

Active Comparator

subcutaneous injection of lipoaspiate enriched with adipose tissue derived stem cells in one temporal region

干预措施: lipofilling enriched with adipose tissue derived stem cells (Procedure)

结局指标

主要结局

Assessment using hollowness severity rating scale :0 : no visible hollowness, 1: mild Hollowness, 2 : moderate Hollowness, 3: severe Hollowness

时间窗: 3 months, 6 months

serial photography for assessment using hollowness severity rating scale :0 : no visible hollowness, 1: mild Hollowness, 2 : moderate Hollowness, 3: severe Hollowness

次要结局

  • Measurement of hypodermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head(3 months, 6 months)
  • Measurement of dermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head Measurement of dermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head(3 months, 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aliaa Ismail Ali Ismail

principle investigator

Alexandria University

研究点 (2)

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