Placental Mesenchymal Stem Cells-derived Exosome for Hairloss
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- visual assessment before and after
研究概览
简要总结
Many people suffer from alopecia, which is caused by hereditary factors, emotional stress, and psychiatric disorders. There are devastating physical and psychological consequences as a result. Exosomes are isolated from donated human amniotic mesenchymal stem cells and purified using specific processing. Exosomes are unique in that they are derived from stem cells and contain a wide range of growth factors. The latest generation of natural products for treating hair loss is exosomes.
详细描述
Exosomes contain a variety of growth factors that are derived from stem cells. As they are so small, they can be hidden in the bloodstream and carry different types of proteins.
The Wnt-β-catenin pathway is thought to play a major role in the pathogenesis of hair loss. The only FDA-approved medications for the treatment of hair loss are minoxidil (a vasodilator) and finasteride (a selective inhibitor of 5α reductase type II and III isoforms). However, these drugs have not been very perfect. Both have been associated with limited efficacy, duration of effect, and several significant side effects. Regenerative medicine using cell products is looking for a way to heal faster and less cost. Present research focus on Exosome efficacy on hairloss.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •subjects able to read the documents and have medical coverage
- •Subjects have a "hair loss grade" as below criteria:
- •BASP grade: Basic type (M2 to M3, or C2 to C3, or U1 to U3) or Specific type (V1 to V3, or F1 to F3)
- •For female: Ludwig grade: Ⅰ to Ⅱ
- •For male: Norwood-Hamilton grade: III to IV
- •Hair density by phototrichogram: 60 to 190 hair/cm2
- •Telogen hair ≥ 5% Subject agreeing not to apply any topical treatment Subject agreeing to use a neutral shampoo
排除标准
- •Sick subject in situation of emergency.
- •Subjects who have hereditary history of hairloss
- •Pregnant Females
- •Subject using topic cosmetic treatment or oral nutritional supplement likely to interfere on hair loss parameters during the last 3 months prior to the start of the study (screening)
- •Subjects who have a medical treatment for alopecia or having stopped it from than 3 months
结局指标
主要结局
visual assessment before and after
时间窗: 6 months
Visual Assessment using the clinical picture by a general physician
Change in mean total hair density (hair/cm2)
时间窗: 6 months
Measurement of hair density by phototrichogram: change in mean total hair density (hair/cm\^2)
次要结局
- Change in mean Telogen and Anagen hair density(6 months)
研究者
Leila Dehghani
Dr Leila Dehghani
Isfahan University of Medical Sciences