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临床试验/NCT06539273
NCT06539273已完成3 期

Effectiveness of Exosome Treatment in Androgenetic Alopecia - Outcomes of a Prospective Study

Yeditepe University Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年1月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Hair density

研究概览

简要总结

This study aims to elucidate the effect of "foreskin-derived mesenchymal stromal cells derived exosome" injection into the scalp on hair density in patients with androgenetic alopecia and the contribution of this treatment on patient satisfaction.

详细描述

Within the scope of this research, we aim to elucidate the effect of "foreskin-derived mesenchymal stromal cells derived exosome" injection into the scalp on hair density in patients with androgenetic alopecia and the contribution of this treatment on patient satisfaction.This prospective study included 30 male patients, aged between 22 and 65, with hair type III-VI according to the Norwood-Hamilton scale, who agreed not to change their hairstyle and would not undergo any hair care or treatment during the study.Foreskin-derived Mesenchymal Stem Cells (MSCs) were utilized, sourced from the Extracellular Vesicle and Exosome Research Laboratory (EVER Lab) at Yeditepe University.The cell culture media is collected from a combination of FBS and antibiotic-free stem cell culture. An ATPS-Exosome isolation solution is prepared by blending Polyethylene glycol (PEG) and Dextran (DEX) at a 7.7:3.3 (w/w) ratio with distilled water.

Stem cell exosome concentration measurement and determination of exosome size and density distribution were conducted using Nanosight NS300 (Malvern Instruments) equipped with a 488 nm laser.Exosomal surface antigens were assessed using Flow Cytometry.

Before the exosome injections of 30 male patients with androgenetic alopecia, frontal and vertex regions where hair loss occurred on the scalp were imaged with a digital camera.An area of 1 cm2 from each of the mentioned areas were selected and 40x magnification images of those areas were taken with digital dermatoscopyUsing these dermatoscopic images, hair densities (hair count/cm2) were recorded with Trichoscan (TrichoLab GmbH, Germany). The patients were called for control at the 4th and 12th weeks after the injection. During these sessions, photographs of the same areas were taken with the same digital camera, from the same distance and under the same light and flash (1/200 s; f/6,3; ISO 160). During the controls, same topographic points were found (2 frontal and 1 vertex points) and these areas were imaged with digital dermatoscopy under x40 magnification. Hair densities were recorded with Trichoscan analyses and the averages of the 3 treated areas were taken.

Additionally, at the 4- and 12-week check-ups, a hair growth survey, as defined by Barber at al, was modified and administered to the patients [8]. In this modified survey, patients were asked 2 questions. Question one was "Has your hair loss decreased?" while the second question was "Have you noticed new hair growing?"

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
22 Years 至 65 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Male patients aged between 22 and 65, with hair type III-VI according to the Norwood-Hamilton scale,
  • Patients who agreed not to change their hairstyle and would not undergo any hair care or treatment during the study

排除标准

  • Patients using finasteride, dutasteride, steroids, vasodilators, anticonvulsants, beta-receptor blockers, bronchodilators, diuretics, spironolactone, cimetidine, diazoxide, cyclosporine, ketoconazole
  • Patients with a history of surgery for hair loss, such as hair transplantation or scalp reduction
  • Patients with a history of topical steroids or hair growth solutions for hair within the last year
  • Patients with uncontrolled blood pressure and blood sugar levels in the last 6 months, infectious skin diseases or psychiatric disorders, a history of treatment of hyperthyroidism or hypothyroidism, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) serum levels >80 mg/dL or creatinine (Cr) level >1.5 mg/dL
  • Patients who were actively pregnant, breastfeeding, or planning to become pregnant within the next 6 months

研究组 & 干预措施

Experimental

Experimental

Intervention group

干预措施: Exosome Complex, RNA (Drug)

结局指标

主要结局

Hair density

时间窗: 4th and 12th weeks

Increase in hair density (number of hair/cm2)

次要结局

  • Patient satisfaction survey(4th and 12th weeks)

研究者

发起方
Yeditepe University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mert Ersan

Asst.Prof.

Yeditepe University Hospital

研究点 (1)

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