Evaluation the clinical use of conditioned media of adipose tissue derived stem cells in the treatment of female pattern hair loss
Design
This study is a pilot study on 12 patients with female pattern hair loss. In each session, one side of the patient's head (intervention group) is injected with conditioned media of adipose derived stem cells, and the other side of the head (control group) with physiological saline. This procedure will be performed once a week for 12 weeks. All patients are photographed before the treatment and in each session by digital camera and trichoscan. 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 ithout informing the patient of the intervention groups, one side of the head is used for conditioned media of adipose derived stem cells 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, Female patients with female pattern 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 1: One side of the head of conditioned media of adipose derived stem cells is injected. Intervention group 2: The other side of the head is injected as a physiological serum control group.
Main outcome variables
The amount of hair loss; side effects; patient's satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046282N5
Registration date:2022-02-20, 1400/12/01
Registration timing:prospective
Last update:2022-02-20, 1400/12/01
Update count:0
Registration date
2022-02-20, 1400/12/01
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
2022-03-12, 1400/12/21
Expected recruitment end date
2022-06-11, 1401/03/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the clinical use of conditioned media of adipose tissue derived stem cells in the treatment of female pattern hair loss
Public title
Evaluation of the effectiveness of conditioned media of adipose derived stem cells in the treatment of hair loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-60
Female patients with female pattern 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
Age
From 20 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
12
More than 1 sample in each individual
Number of samples in each individual:
2
A half head will be considered as the control group and one half as an intervention group.
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, conditioned media of adipose derived stem cells and on the other side of the head, saline solution are injected.
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
Keshavarz blvd, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1937957511
Approval date
2021-07-22, 1400/04/31
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.496
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 treatment and one month after the last session
Method of measurement
Trichoscan
Secondary outcomes
1
Description
side effects
Timepoint
One week after session
Method of measurement
Questionnaire and visit
Intervention groups
1
Description
Control group: (other side of the head) physiological serum is injected. This will be done once a week for 12 weeks.
Category
Treatment - Other
2
Description
Intervention group: On one side of the head, conditioned media of adipose derived stem cells is injected. This will be done once a week for 12 weeks.
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
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
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Skin and Stem cell Research Center of 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
Specialist
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