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Evaluation the efficacy of mesenchymal stem cells condition medium on hair transplantation outcome

Protocol summary

Study aim
Evaluation the efficacy of mesenchymal stem cells condition medium on hair transplantation outcome
Design
This study is performed as phase 1 and 2 on 30 hair transplant patients. Two weeks after transplantation, conditioned medium is injected and sprayed 5 times subcutaneously at the operation site 5 times in the intervention group and in the control group. All patients are photographed before the treatment and in each session by digital camera and tricoscan. 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 Jordan Clinic and two weeks after transplantation, in the intervention group, conditioned medium is injected 5 times two weeks apart and in the control group, PRP is injected subcutaneously at the operation site.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Candidate patients for hair transplantation, no internal diseases other than hypothyroidism, no use of drugs that cause hair loss such as chemotherapy, psychotropic drugs, anticoagulants, cardiovascular, retinoids, antimicrobials, lack of androgenic hormones Psychiatry such as obsessive-compulsive disorder and trichotillomania, absence of active infection in the transplant area, age between 18-50 years. Exclusion criteria: unwillingness to continue co-operation, pregnancy, lactation, exposure to acute and severe stress during the study, xylocaine allergy
Intervention groups
Two weeks after transplantation, conditioned medium is injected and sprayed 5 times subcutaneously at the operation site 5 times in the intervention group and in the control group.
Main outcome variables
The result of hair transplantation; side effects; Patient satisfaction; Wound healing rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200127046282N18
Registration date: 2022-06-05, 1401/03/15
Registration timing: prospective

Last update: 2022-06-05, 1401/03/15
Update count: 0
Registration date
2022-06-05, 1401/03/15
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
2022-06-20, 1401/03/30
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy of mesenchymal stem cells condition medium on hair transplantation outcome
Public title
Evaluation the efficacy of stem cells condition medium on hair transplantation outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate hair transplant patients Absence of internal diseases except hypothyroidism Do not take drugs that cause hair loss such as chemotherapy, psychotropic drugs, anticoagulants, cardiovascular, retinoids, antimicrobials, androgen hormones Absence of psychiatric diseases such as obsessive-compulsive disorder and trichotillomania Absence of active infection in the transplanted area Age between 18-50 years
Exclusion criteria:
Reluctance to continue cooperation Pregnancy Breastfeeding Exposure to acute and severe stress during the study Allergy to xylocaine
Age
From 18 years old to 50 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients participating in this study and analyzing the data are unaware of the study groups. Therefore, the study 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 Tehran University of Medical Sciences
Street address
Keshavarz blvd, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1937957511
Approval date
2022-02-16, 1400/11/27
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1373

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
Hair recovery rate
Timepoint
Before treatment and six months 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: Two weeks after the hair transplant, 3 cc stem cells condition medium is injected subcutaneously five times every two weeks at the transplant site and sprayed a little.
Category
Treatment - Other

2

Description
Control group: Two weeks after the hair transplant, 3 cc platelet rich plasma is injected subcutaneously five times every two weeks at the transplant site and sprayed a little.
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
Analytic Code
Not applicable
Data Dictionary
Not applicable
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