Investigating the effectiveness of extracellular vesicles released from mesenchymal stem cells in thetreatment of patients with persistent vitiligo lesions: a pilot study
Efficacy of EV-MSCs in the treatment of patients with persistent vitiligo lesions
Design
Extracellular vesicles are isolated after culture of human mesenchymal stem cells and stored in sterile vials. Then they are used by dermatologists for vitiligo patients.
Settings and conduct
This study is conducted at the Skin Research Center. Vitiligo patients will be treated with extracellular vesicles released from MSCs. After anesthetizing the recipient area, a 2 x 2 CM area is made by the doctor using a microneedling device to create surface holes in the skin, and a solution containing particles is sprayed in the target area. Before the treatment, the treated area is medically evaluated and the amount of pigments present, and a photo is taken of this area, after which patients are visited monthly for 3 months and then 6 months later for a long-term evaluation of the effect of the treatment.
Participants/Inclusion and exclusion criteria
Patients with stable vitiligo and the stability of the disease based on the absence of new lesions during the last year. Exclusion: Patients with more than 20% of the body surface involved, pregnant and lactating women, patients with skin cancer and patients who have undergone other treatments for vitiligo in the last 3 months.
Intervention groups
6 patients (female, male) between 18 and 50 years old with stable vitiligo
Main outcome variables
Skin pigmentation changes of vitiligo patients before and after treatment with extracellular vesicles released from mesenchymal stem cells.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240508061704N1
Registration date:2024-05-25, 1403/03/05
Registration timing:prospective
Last update:2024-05-25, 1403/03/05
Update count:0
Registration date
2024-05-25, 1403/03/05
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
Investigating the effectiveness of extracellular vesicles released from mesenchymal stem cells in thetreatment of patients with persistent vitiligo lesions: a pilot study
Public title
- Possible treatment of vitiligo lesions by particles isolated from stem cells in the laboratory
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients should have stable vitiligo
The patient's medical history should report the stability of the patient's disease in terms of the absence of new lesions during the last one year
Exclusion criteria:
Patients with more than 20% of the body surface involved with vitiligo
pregnant women
lactating women
patients with skin cancer
patients who have undergone other treatments for vitiligo in the past 3 months
Age
From 18 years old to 50 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
6
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
2024-02-17, 1402/11/28
Ethics committee reference number
IR.SUMS.REC.1402.560
Health conditions studied
1
Description of health condition studied
vitiligo
ICD-10 code
L80
ICD-10 code description
Vitiligo
Primary outcomes
1
Description
Increase in pigment production
Timepoint
After drug treatment, monthly visits are made for up to three months, and for long-term visits after 6 months.
Method of measurement
Vitiligo Area Scoring Index (VASI)
Secondary outcomes
empty
Intervention groups
1
Description
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.After the patient is admitted, the recipient area is anesthetized with an antiseptic chlorhexidine solution and then with 2.5% lidocaine cream, and then a 2x2 cm2 area of the skin is microneedling with a dermapen, and the solution contains extracellular vesicles isolated from mesenchymal stem cells. human (2cc containing 400µg/ml) is sprayed in the desired area. Before the treatment, the treated area is medically evaluated and the amount of pigments present, and a photo is taken of this area, after which patients are visited monthly for 3 months and then 6 months later for a long-term evaluation of the effect of the treatment.
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, Shiraz-Iran
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, Shiraz-Iran
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
Negin Fazelzade Haghighi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
dermatology
Street address
Molecular Dermatology Research Center Shahid Faghihi hospital, Zand Avenue, Shiraz-Iran
City
Shiraz
Province
Fars
Postal code
7134844119
Phone
+98 71 3212 5592
Email
Neginfzd@yahoo.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, Shiraz-Iran
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
En Demographic characteristics of the results of Investigating the effectiveness of extracellular vesicles released from mesenchymal stem cells in the treatment of patients with persistent vitiligo lesions: 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 somayeh keshtkar- somayehkeshtkar@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. Somayeh Keshtkar@gmail.com, to the email address of somayehkeshtkar@gmail.com. After reviewing it within a week, after receiving a commitment, the data will be sent to the applicant via email.