Evaluation of the therapeutic results of using stem cells isolated from hair follicles for the treatment of baldness
Design
Clinical trial on 10 patients without randomization and blinding, phase 3 and with placebo
Settings and conduct
In this study, male patients with baldness will be investigated. Identification and confirmation of patients with baldness will be done by observing an increase in the number of end-point hairs, or a decrease in the number of hairs in a physical examination and phototrichogram along with a negative hair pull test.
Participants/Inclusion and exclusion criteria
Inclusion criteria were baldness stage 3 to 5 according to Norwood-Hamilton classification and consent to participate in the study. Patients with sepsis, immune system suppression, cancer and use of medical treatments for baldness (such as finasteride, dutasteride, or antiandrogens) during the past 12 months will excluded.
Intervention groups
Intervention group: After extracting the scalp tissues through the punch biopsy method, the scalp tissue will be cut into 2 mm x 2 mm strips, and the excess fat tissue will be separated along with the skin. These strips will be collected and separated slowly in 1.2 ml of the physiological solution under sterile conditions (vertical layer flow hood) and then centrifuged for 60 seconds at 80 rpm. Then sediment cells will be mechanically injected into the scalp of bald patients.
Control group: After dividing the scalp into different parts, a placebo (normal saline) will be injected into one of these areas to compare the results with the intervention.
Main outcome variables
Hair growth
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100314003566N12
Registration date:2023-02-06, 1401/11/17
Registration timing:prospective
Last update:2023-02-06, 1401/11/17
Update count:0
Registration date
2023-02-06, 1401/11/17
Registrant information
Name
Hamide Azimi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1540 6612
Email address
azimih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-19, 1401/11/30
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Therapeutic results of stem cells isolated from hair follicles in baldness treatment
Public title
Baldness treatment using stem cells
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Baldness stage 3 to 5 according to Norwood-Hamilton classification
Consent to participate in the study
Exclusion criteria:
Sepsis
Immune system suppression
Cancer
Use of medical treatments for baldness (such as finasteride, dutasteride, or antiandrogens) during the past 12 months
Age
From 30 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee Of Tabriz University Of Medical Sciences.
Street address
Third Floor, Central Building of Number 2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Approval date
2023-01-23, 1401/11/03
Ethics committee reference number
IR.TBZMED.REC.1401.961
Health conditions studied
1
Description of health condition studied
Baldness
ICD-10 code
L65.9
ICD-10 code description
Nonscarring hair loss, unspecified
Primary outcomes
1
Description
Hair growth
Timepoint
3 weeks, 9 weeks, 16 weeks and 23 weeks after the intervention
Method of measurement
Hair growth in patients will be objective compared by the dermatologist's opinion after the last treatment using photography with the initial assessment done before and after treatment and between the treated area of the intervention and also the control area where the placebo injection was done.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After extracting the scalp tissues through the punch biopsy method, the scalp tissue will be cut into 2 mm x 2 mm strips, and the excess fat tissue will be separated along with the skin. These strips will be collected and separated slowly in 1.2 ml of the physiological solution under sterile conditions (vertical layer flow hood) and then centrifuged for 60 seconds at 80 rpm. Then sediment cells will be mechanically injected into the scalp of bald patients.
Category
Treatment - Drugs
2
Description
Control group: After dividing the scalp into different parts, a placebo (normal saline) will be injected into one of these areas to compare the results with the intervention.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dermatology Clinic of Sina Hospital
Full name of responsible person
Dr.Hamideh Azimi
Street address
Dermatology ward, Sina Hospital, Azadi Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 3541 2103
Email
azimi@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Abolghasem Juiban
Street address
Third Floor, Central Building of Number 2, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
51386631357
Phone
+98 41 3553 9161
Email
lahroudin@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hamide Azimi
Position
Dermatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina hospital, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 1540 6612
Fax
Email
azimi@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hamide Azimi
Position
Dermatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina hospital, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 1540 6612
Fax
Email
azimi@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Hamide Azimi
Position
Dermatologist
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Sina hospital, Azadi avenue
City
Tabriz
Province
East Azarbaijan
Postal code
5138665793
Phone
+98 41 1540 6612
Fax
Email
azimi@tbzmed.ac.ir
Web page address
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
No - There is not 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
Study data is categorized and coded with no identifiable individuals.
When the data will become available and for how long
Access to study data after publication of the result is available in the journal.
To whom data/document is available
Anyone interested in using the data can access the study data.
Under which criteria data/document could be used
Study data can be used for comparison with other results.
From where data/document is obtainable
Refer to the study's scientific or public accountability person for data.
What processes are involved for a request to access data/document
The request will be sent by email to person responsible for scientific or public inquiries.