1- َAssessment of probable local or systemic side effects after tissue-engineered skin containing hair follicles engrafment 2. Determine the number and thickness of formed hairs
Design
One group, uncontrolled, phase I clinical trial among 5 patients and 6 months follow up
Settings and conduct
Participants suffering from male pattern hair loss referring to the Skin and Stem Cells Center, will recieve autologous tissue engineered hair follicle onto the target area and the area will be bandaged. Participants will be screened for safety of transplantation, and thickness, density and number of formed hairs using Trichograms every four weeks for 6 months
Participants/Inclusion and exclusion criteria
Inclusion criteria: age more than 25, male, Hamilton scaling male pattern hair loss more than 3. Exclusion criteria: History of malignancy, Known chronic disease, Systemic or local active infection, History of cell therapy or hair transplantation, Viral infections (HBV, HIV, HCV)
Safety; thickness, density and number of formed hairs
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001159N32
Registration date:2021-03-09, 1399/12/19
Registration timing:prospective
Last update:2021-03-09, 1399/12/19
Update count:0
Registration date
2021-03-09, 1399/12/19
Registrant information
Name
Mohamad Ali Nilforoushzadeh
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 5158
Email address
sdlrc@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-03-16, 1400/12/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the transplatation of tissue-engineered skin containing hair follicles in androgenetic alopecia; a phase 1 clinical trial
Public title
Evaluation of tissue-engineered hair follicles in hair loss
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hamilton scaling male pattern hair loss more than 3
Exclusion criteria:
History of malignancy
Known chronic disease
Systemic or local active infection
Histroy of cell therapy or hair transplantation
Viral infections (HBV,HIV و HCV)
History of allergies and sensitivities
Patients with contact dermatitis, psoriasis, itching or dry skin
Mood disorders, depression, or neuropathy
Anti coagulative drugs
Hypo/ hyperthyroidism
Age
From 25 years old
Gender
Male
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
5
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 Tehran University of Medical Sciences
Street address
Deputy for research and Technology, Central building, Tehran University of Medical Sciences, Qods street, Keshavarz boulevard
City
Tehran
Province
Tehran
Postal code
1416613675
Approval date
2020-12-02, 1399/09/12
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1399.841
Health conditions studied
1
Description of health condition studied
Androgenetic alopecia
ICD-10 code
L64
ICD-10 code description
Androgenic alopecia
Primary outcomes
1
Description
Safety
Timepoint
Intervention start date up to 6 months
Method of measurement
Medical history and physical examination
Secondary outcomes
1
Description
Number of formed hairs
Timepoint
Before intervention, every 4 weeks up to 6 months
Method of measurement
Trichogram
2
Description
Thickness of formed hairs
Timepoint
Before intervention, every 4 weeks up to 6 months
Method of measurement
Trichogram
3
Description
Density of formed hairs
Timepoint
Before intervention, every 4 weeks up to 6 months
Method of measurement
Trichogram
Intervention groups
1
Description
Intervention group: Tissue engineered skin in 3 cm diameter containing 100 hair follicles, single session engrafment
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin and Stem cell Research Center
Full name of responsible person
Mohammad Ali Nilforooshzadeh
Street address
Maryam alley, Pasha Zahari street, South Kamranieh
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 2537
Email
nilforoushzadeh@mui.ac.ir
Web page address
http://skinstemcell.ir/
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
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2251 5558
Email
tmarkaz@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 Cells Research Center of Tehran University of Medical Sciences
Full name of responsible person
Amir Bajouri
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Cell science and application
Street address
Maryam alley, Pasha Zahari street, South Kamranieh
City
Tehran
Province
Tehran
Postal code
16635148
Phone
+98 21 2356 2173
Email
bajouri.md@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical sciences
Full name of responsible person
Mohamad Ali Nilforoushzadeh
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
No 4, Maryam alley, Southern Kamraniyeh, Tehran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2220 5158
Fax
+98 21 2223 9264
Email
sdlrc@mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Skin and Stem Cells Research Center of Tehran University of Medical Sciences
Full name of responsible person
Amir Bajouri
Position
PhD student
Latest degree
Medical doctor
Other areas of specialty/work
Cell science and application
Street address
No 4, Maryam alley, South Kamraniye
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 2537
Email
bajouri.md@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is 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
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Participants' data will be shared after unidentifiable of the patients
When the data will become available and for how long
6 months after paper publication
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
In term of analysis the data related to participants
From where data/document is obtainable
bajouri.md@gmail.com
What processes are involved for a request to access data/document
The request will be assessed by research committee of Skin and Stem cells research center which will be taken around 1-2 months