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临床试验/NCT06697080
NCT06697080进行中(未招募)不适用

A Randomized-controlled Clinical Trial to Treat Chinese Advanced AGA With Umbilical Cord-derived Mesenchymal Stem Cell Exosomes

Nanfang Hospital, Southern Medical University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年6月28日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Experimental

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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