Study of safety and effectiveness of mesenchymal stem cells condition medium in the treatment of hair loss (phases I and II )
Design
This study is performed as phase 1 and 2 on 45 patients with hair loss. In each session, one side of the patient's head (intervention group) is injected with Wharton jelly mesenchymal stem cells conditioned medium, and the other side of the head (control group) with physiological serum is injected. This method will be performed once a month for 3 months. All patients are photographed before the treatment and in each session by digital camera and tricoscan. To determine the extent of recovery and compare the two sides of the head, at the end of the study, photos of patients are examined by two neutral dermatologists. Patient satisfaction is also recorded and the results are compared.
Settings and conduct
This project is performed in the skin and stem cell research center of Tehran university of medical sciences and without informing the patient of the intervention groups, one side of the head is used for Wharton jelly mesenchymal stem cells conditioned medium and the other side is used for blinding physiological serum in areas of hair loss.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 20-60, patients with hair loss, Patients who do not want to take or are allergic to minoxidil. Exclusion criteria: Individuals who have used any product or medication during the previous 6 months that may affect hair growth, Pregnancy and breastfeeding History of cancer, People with Mental Disorders, Active infection of the scalp.
Intervention groups
Intervention group: One side of the head mesenchymal stem cells conditioned medium is injected. control group: The other side of the head is injected physiological serum as a control group.
Main outcome variables
The amount of hair loss; side effects; patient's satisfaction; effectiveness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046282N13
Registration date:2022-05-01, 1401/02/11
Registration timing:registered_while_recruiting
Last update:2022-05-01, 1401/02/11
Update count:0
Registration date
2022-05-01, 1401/02/11
Registrant information
Name
Sona Zare
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2665 7438
Email address
sonazarebio@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-14, 1401/01/25
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of safety and effectiveness of mesenchymal stem cells condition medium in the treatment of hair loss (phases I and II )
Public title
Evaluation of the safety and effectiveness of mesenchymal stem cells conditioned medium in the treatment of hair loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who do not want to take minoxidil.
Patients who are allergic to minoxidil.
Exclusion criteria:
The patient has used an effective drug in hair loss during the last 6 months.
Age
From 20 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
At each session on one side of the head, mesenchymal stem cells conditioned medium and on the other side of the head, saline solution is injected. Participants and data analysts will not know about the intervention groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Keshavarz blvd
City
Tehran
Province
Tehran
Postal code
1937957511
Approval date
2021-11-29, 1400/09/08
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.999
Health conditions studied
1
Description of health condition studied
Hair loss
ICD-10 code
L65.9
ICD-10 code description
Nonscarring hair loss, unspecified
Primary outcomes
1
Description
The amount of hair loss
Timepoint
Before starting treatment, end of the first, second, third month and one month after the end of the treatment period (end of the fourth month)
Method of measurement
Trichoscan
Secondary outcomes
1
Description
side effects
Timepoint
Before starting treatment, end of the first, second, third month and one month after the end of the treatment period (end of the fourth month)
Method of measurement
Questionnaire and visit
2
Description
effectiveness
Timepoint
Before starting treatment, end of the first, second, third month and one month after the end of the treatment period (end of the fourth month)
Method of measurement
Questionnaire and visit
Intervention groups
1
Description
Control group: One side of the physiological serum is injected. This will be done once a month for 3 months.
Category
Treatment - Other
2
Description
Intervention group: Wharton jelly mesenchymal stem cells conditioned medium is injected on the side of the head. This will be done once a month for 3 months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
Dr_nilforoush@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotoohi
Street address
Central University Organization, sixth floor, Vice Chancellor for Research and Technology, corner of Quds Street, Keshavarz Boulevard
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Sona Zare
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Cellular and Molecular biology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
sonazarebio@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Position
Professor
Latest degree
A Level or less
Other areas of specialty/work
Dermatology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
Dr_nilforoush@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Sona Zare
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Cellular and Molecular Biology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
sonazarebio@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available