Investigating the safety and efficacy of Wharton jelly mesenchymal stem cell conditioned medium injection in male androgenetic alopecia (phase 1 and 2 clinical trial)
Investigating the safety and efficacy of Wharton jelly mesenchymal stem cell conditioned medium injection in male androgenetic alopecia (phase 1 and 2 clinical trial)
Design
This study is conducted in phase 1 and 2 on 40 patients suffering from hair loss. The study will be parallel and double-blind.
Settings and conduct
This project is carried out at the Skin and Stem Cell Research Center of Tehran University of Medical Sciences, and injections are used in hair loss areas without the knowledge of the patient and the outcome evaluator of the intervention groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with male androgenic hair loss grade 3-5, age between 25 and 45 years. Exclusion criteria: evidence of sepsis, immunosuppression and cancer, use of oral drug treatment, use of topical drug treatment, discovery of another cause for the patient's hair loss, lack of patient cooperation.
Intervention groups
Intervention group: The patient's head will receive 2 cc of condition medium 2 times with an interval of 60 days. Control group: will be sick before.
Main outcome variables
The amount of hair loss; side effects; effectiveness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046282N39
Registration date:2024-06-08, 1403/03/19
Registration timing:prospective
Last update:2024-06-08, 1403/03/19
Update count:0
Registration date
2024-06-08, 1403/03/19
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
2024-06-14, 1403/03/25
Expected recruitment end date
2024-09-05, 1403/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the safety and efficacy of Wharton jelly mesenchymal stem cell conditioned medium injection in male androgenetic alopecia (phase 1 and 2 clinical trial)
Public title
Investigating the safety and effectiveness of conditioned medium injection of stem cells in male androgenetic alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with male androgenetic alopecia grade 3-5
Age between 25 and 45 years
Exclusion criteria:
Presence of evidence of sepsis
immunosuppression and cancer
Use of oral drug treatment for androgenic hair loss (such as finasteride, dutasteride or any other anti-androgen drug) in 12 months the past
Use of local drug treatment of androgenic hair loss (such as minoxidil, prostaglandin analogues, retinoids or Corticosteroids) in the last 12 months
Discovering another cause for the patient's hair loss
Non-cooperation of the patient until the end of the study
Age
From 25 years old to 45 years old
Gender
Male
Phase
1-2
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The outcome evaluator and the patients do not know about the intervention groups. The injection syringe will be covered with aluminum foil.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Oncology, Hematology and Tuberculosis Research Institute - Tehran Unive
Street address
North Kargar Street, Shariati Hospital
City
Tehran
Province
Tehran
Postal code
1411713135
Approval date
2023-06-14, 1402/03/24
Ethics committee reference number
IR.TUMS.HORCSCT.REC.1402.013
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 (pain, burning, inflammation)
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 (increasing the number of hair, increasing the thickness)
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
Intervention group: The patient's head will receive 2 cc of conditioning medium 2 times with an interval of 60 days.
Category
Treatment - Other
2
Description
Control group: the position of the patient's head will be before the intervention.
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
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
Ali Akbari Sari
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 3685
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
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
Specialist
Other areas of specialty/work
Dermatology
Street address
No 4, Maryam Alley, South Kamraniyeh Street
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
009826657438
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
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