A Randomized-controlled Clinical Trial to Treat Chinese Advanced AGA With Umbilical Cord-derived Mesenchymal Stem Cell Exosomes
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- hair diameters changed over time
研究概览
简要总结
A total of 50 patients with androgenetic alopecia were selected for the study. Patients who met the inclusion/exclusion criteria were randomly assigned to groups A and B in a 1:1 ratio to receive treatment, with the enrollment date designated as Day 1. Group A visited the clinic once each in the first, second, and third months for treatment with exosomes, while Group B visited the clinic twice each in the first, second, and third months for treatment with exosomes. At the time points of 1, 2, 3, and 6 months after the start of the treatment period, dermatoscopic examinations were conducted on patients in both groups. The differences in hair growth density, hair shaft thickness, and follicle counts within a 1 cm diameter area were compared between the two groups. Additionally, the data differences for each subject at baseline and at the end of the experiment were also assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of Androgenic alopecia · AGA classification include:The No grade for male hair loss was II-V, and the Ludwig grade for female hair loss was I-III
排除标准
- •(1) Using medications or supplements, including finasteride, dutasteride, minoxidil or any other hormonal products, that can affect hair growth; · (2) Patients with severe diseases, immune diseases, endocrine diseases and nervous system diseases; (3) Patients with infection, allergic disease and malignant tumor
研究组 & 干预措施
Group A
Group A visited the clinic once each in the first, second, and third months for treatment with exosomes
干预措施: Human umbilical cord mesenchymal stem cells (Drug)
Group B
Group B visited the clinic twice each in the first, second, and third months for treatment with exosomes.
干预措施: Human umbilical cord mesenchymal stem cells (Drug)
结局指标
主要结局
hair diameters changed over time
时间窗: 0 days, 1 month, 3 months, 6 months
hair diameters changed over time
次要结局
未报告次要终点
