Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539273
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
Exosome Treatment in Androgenetic Alopecia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness of Exosome Treatment in Androgenetic Alopecia - Outcomes of a Prospective Study
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 satisfactionThis 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 studyForeskin-derived Mesenchymal Stem Cells MSCs were utilized sourced from the Extracellular Vesicle and Exosome Research Laboratory EVER Lab at Yeditepe UniversityThe 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 7733 ww 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 laserExosomal 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 cameraAn 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 countcm2 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 1200 s f63 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
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 laserExosomal 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 cameraAn 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 countcm2 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 1200 s f63 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None