Investigating the safety and efficacy of intradermal injection of autologous Nanofat and conditioned medium derived from Wharton jelly mesenchymal stem cells in the treatment of androgenic alopecia compared to Nanofat alone: a double-blind clinical trial study
Investigating the safety and efficacy of intradermal injection of autologous Nanofat and conditioned medium derived from Wharton jelly mesenchyme stem cells in the treatment of androgenic alopecia compared to Nanofat alone
Design
A controlled, parallel-group, double-blind, randomized, phase 1 clinical trial on 10 patients.
Settings and conduct
This project is carried out at the Skin and Stem Cell Research Center of Tehran University of Medical Sciences. It will have two intervention groups, Nanofat and condition medium, and control Nanofat and normal saline.
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
Condition medium and nanofat are injected in the intervention group and nanofat is injected in the 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:IRCT20200127046282N34
Registration date:2024-05-25, 1403/03/05
Registration timing:prospective
Last update:2024-05-25, 1403/03/05
Update count:0
Registration date
2024-05-25, 1403/03/05
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
2024-06-04, 1403/03/15
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 intradermal injection of autologous Nanofat and conditioned medium derived from Wharton jelly mesenchymal stem cells in the treatment of androgenic alopecia compared to Nanofat alone: a double-blind clinical trial study
Public title
Investigating nanofat injection and conditioned medium derived from stem cells in the treatment of androgenic alopecia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-60
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 18 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
Considering that the number of cases in this research plan is 10 people, the head area should be randomly divided into two groups, therefore, the randomization method in this research plan will be done in such a way that the head area will be done by systematic randomization method and the resulting numbers The computer will be divided into intervention and control groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
The doctor and the patient will not know the contents of the injection syringe.
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
2023-06-14, 1402/03/24
Ethics committee reference number
IR.TUMS.HORCSCT.REC.1402.009
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
Intervention group: One side of the head nanofat and condition medium is injected once.
Category
Treatment - Other
2
Description
Control group: One side of the head of nanofet and normal salineis injected once.
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
ِDr Ali Akbari Sari
Street address
6th floor of Research and Technology Vice-Chancellor, Central Organization of the University, corner of Quds St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
vcr@sina.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
Subspecialist
Other areas of specialty/work
Dermatology
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
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