Efficacy of extracellular vesicles released from mesenchymal stem cells in the treatment of male androgenetic hair loss
Design
First, extracellular vesicles are isolated from human mesenchymal stem cells and then injected by the doctor into specific areas of the patient's head.
Settings and conduct
This study is conducted at the Skin Research Center. Selected patients will be treated with particles isolated from stem cells. After anesthetizing the recipient area, the doctor injects a solution containing particles isolated from stem cells using a #30 insulin syringe at a distance of 2.5 cm from each other. Before the treatment, patients are evaluated by a dermatologist and the treated area is photographed by the Vizioface imaging device and dermoscope. After 3 and 6 months, the treatment response is performed again by a dermatologist.
Participants/Inclusion and exclusion criteria
5 men with baldness degree three to four.
Patients receiving treatment during the last 3 months or systematic treatment of immunosuppressive drugs or modulators in the last 3 months, receiving anticoagulant drugs, history of hair transplantation, malignancy, injection phobia, infection or inflammation of the scalp, serious and uncontrolled diseases Internally, such as diabetes and autoimmune diseases, patients with unrealistic expectations of treatment will not be included in the study.
Intervention groups
5 patients with male hereditary-hormonal hair loss, grade three to four
Main outcome variables
Comparison of the number of terminal hairs in dermoscopy after and before treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240508061704N2
Registration date:2024-05-30, 1403/03/10
Registration timing:prospective
Last update:2024-05-30, 1403/03/10
Update count:0
Registration date
2024-05-30, 1403/03/10
Registrant information
Name
Somayeh Keshtkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3212 5592
Email address
somayehkeshtkar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-05, 1403/04/15
Expected recruitment end date
2025-03-05, 1403/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of the effect of extracellular vesicles derived from mesenchymal stem cells in the management ofmale androgenetic alopecia: a pilot study
Public title
Possible treatment of hereditary-hormonal hair loss by particles isolated from stem cells in the laboratory
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with male hereditary-hormonal hair loss
Patients with hair loss grade three to four Norwood-Hamilton classification
Exclusion criteria:
Patients receiving treatment for androgenetic alopecia during the last 3 months
Patients receiving systematic treatment of immunosuppressive or modulating drugs in the last 3 months
Patients receiving anticoagulants
Patients with a history of hair transplantation
Patients with a history of malignancy
Patients with a history of injection phobia
Patients with scalp infection or inflammation
Patients with serious and uncontrolled internal diseases such as diabetes and autoimmune diseases
Patients with unrealistic expectations of treatment
Age
From 20 years old to 50 years old
Gender
Male
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Molecular Dermatology Research Center Shahid Faghihi hospital, Zand Avenue, Shiraz-Iran
City
Shiraz
Province
Fars
Postal code
7134844119
Approval date
2024-04-28, 1403/02/09
Ethics committee reference number
IR.SUMS.REC.1403.059
Health conditions studied
1
Description of health condition studied
androgenetic alopecia
ICD-10 code
L64
ICD-10 code description
Androgenic alopecia
Primary outcomes
1
Description
Increased rate of hair growth
Timepoint
A visit is done 3 months and 6 months after drug treatment
Method of measurement
Dermoscopic trichoscopy and hair count
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, the extracellular vesicles isolated from Wharton's jelly umbilical cord mesenchymal stem cells are separated and stored in phosphate buffered saline (PBS) in the freezer. It becomes numb and the solution containing extracellular vesicles isolated from human mesenchymal stem cells is injected using a #30 insulin syringe at a distance of 2.5 cm from each other. 0.1 cc is injected at each point. The sample volume is injected between 1-3 cc (with a concentration of 200 µg/ml) according to the size of the treatment site.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Molecular Dermatology Research Center
Full name of responsible person
somayeh keshtkar
Street address
Molecular Dermatology Research Center Shahid Faghihi hospital, Zand Avenue
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5592
Email
somayehkeshtkar@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Mohammad Hashem Hashempour
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3235 7282
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Somayeh Keshtkar
Position
Laboratory expert
Latest degree
Ph.D.
Other areas of specialty/work
Molecular medicine
Street address
Molecular Dermatology Research Center Shahid Faghihi hospital, Zand Avenue,
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5592
Email
somayehkeshtkar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mozhdeh Sepaskhah
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
dermatology
Street address
Molecular Dermatology Research Center Shahid Faghihi hospital, Zand Avenue,
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5592
Email
m.sepaskhah@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Somayeh Keshtkar
Position
Laboratory expert
Latest degree
Ph.D.
Other areas of specialty/work
Molecular medicine
Street address
Molecular Dermatology Research Center Shahid Faghihi hospital, Zand Avenue,
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5592
Email
somayehkeshtkar@gamil.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic characteristics from the results of a project to investigate the effectiveness of extracellular vesicles derived from mesenchymal stem cells in the treatment of male androgenetic hair loss: a pilot study
When the data will become available and for how long
Immediately after the publication of the article
To whom data/document is available
Researchers
Under which criteria data/document could be used
Send researchers' requests via email and make a commitment to applicants to protect the data
From where data/document is obtainable
Sending researchers' requests via e-mail to the e-mail address of the executor and in charge of the project, Dr. Mozhdeh Sepaskhah- m.sepaskhah@gmail.com
What processes are involved for a request to access data/document
The applicant researcher has sent his request to the email address of the executive and project manager, Dr.Mozhdeh Sepaskhah, to the email address of m.sepaskhah@gmail.com. After reviewing it within a week, after receiving a commitment, the data will be sent to the applicant via email.