IRCT | Investigating the safety and efficacy of Wharton jelly mesenchymal stem cells secretome injection in female androgenetic alopecia (Clinical, Biometric and Histopathological evaluation)

Protocol summary

Study aim: Investigating the safety and efficacy of Wharton jelly mesenchymal stem cells secretome injection in female androgenetic alopecia
Design: This study is conducted in phase 1 and 2 on 20 patients suffering from hair loss. In the intervention group, each patient received 3 sessions of direct and intradermal condition medium injection at an interval of 4 weeks, and in the control group, normal saline injection was performed. All patients are photographed by a digital camera and trichoscan before treatment and at each visit session. To determine the recovery rate and compare the two sides of the head, at the end of the study, the photos of the patients are examined by 2 impartial dermatologists. Also, the satisfaction of the patients is recorded and the results are compared.
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 doctor of the intervention groups.
Participants/Inclusion and exclusion criteria: Inclusion criteria: patients with female androgenic hair loss grade 5, patients aged 30 to 45 years, Hormonally healthy patients. Exclusion criteria: evidence of sepsis, immunosuppression and cancer, use of oral drug treatment, use of local drug treatment, discovery of another cause for the patient's hair loss, patient's non-cooperation.
Intervention groups: Intervention group: For each patient, there are 3 sessions of conditioned medium injection in the area with hair loss at an interval of 4 weeks. Control group: For the patient, normal saline is injected for three sessions and at an interval of one month.
Main outcome variables: The amount of hair loss; side effects; effectiveness

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20200127046282N41

Registration date: 2024-06-09, 1403/03/20

Registration timing: registered_while_recruiting

Last update: 2024-06-09, 1403/03/20

Update count: 0
Registration date: 2024-06-09, 1403/03/20

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 Wharton jelly mesenchymal stem cells secretome injection in female androgenetic alopecia (Clinical, Biometric and Histopathological evaluation)

Public title: Investigating the safety and efficacy of mesenchymal stem cells secretome injection in female androgenetic alopecia
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

patients with female androgenetic alopecia grade 5 Patients aged 30 to 45 years Hormonally healthy patients

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 orCorticosteroids) 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 30 years old to 45 years old
Gender: Female

Phase

1-2

Groups that have been masked

Participant
Outcome assessor

Sample size

Target sample size: 20

Randomization (investigator's opinion)

Randomized

Randomization description

The heads of the patients are randomly divided into two groups. One side is treated with conditioning medium injection and the other side is treated with normal saline injection in 3 sessions with an interval of 1 month. Randomization is based on the table of random numbers.

Blinding (investigator's opinion)

Double blinded

Blinding description

The outcome evaluator and the patients do not know about the specialty of the intervention groups. The injection syringe will be covered with aluminum foil. So it will be double blind.

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

Shariati Hospital, North Kargar Street

City

Tehran

Province

Tehran

Postal code

1411713135
Approval date: 2023-06-14, 1402/03/24
Ethics committee reference number: IR.TUMS.HORCSCT.REC.1402.015

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
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
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: For each patient, there are 3 sessions of direct and intradermal conditioned medium injection in the area with hair loss at an interval of 4 weeks.
Category: Treatment - Other

2

Description: Control group: For the patient, normal saline is injected intradermally for three sessions and at an interval of one month.
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

1

Sponsor: Name of organization / entity

Tehran University of Medical Sciences

Full name of responsible person

Akbar Fotoohi

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, 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

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
Analytic Code: Not applicable
Data Dictionary: Not applicable

Investigating the safety and efficacy of Wharton jelly mesenchymal stem cells secretome injection in female androgenetic alopecia (Clinical, Biometric and Histopathological evaluation)