Comparing the effectiveness of conditioned medium derived from Wharton's jelly mesenchymal stem cells, extracellular vesicles derived from Wharton's jelly and triamcinolone in the treatment of lichen Plano Pilaris
Comparing the effectiveness of conditioned medium derived from Wharton's jelly mesenchymal stem cells, extracellular vesicles derived from Wharton's jelly and triamcinolone in the treatment of lichen Plano Pilaris
Design
This study is conducted in phase 1 and 2 on 30 patients with lichen planopilaris. All patients are photographed by a digital camera and tricoscan before treatment and at each visit session. To determine the recovery rate, at the end of the study, the photos of the patients are examined by 2 neutral 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 on lichen planopillaris patients. There are two intervention groups and one control group, and the patient and the data evaluator do not know about the intervention groups and are blinded.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age between 18-60 years, lichen planopilaris disease has been proven. Exclusion criteria: breastfeeding, pregnancy, infectious diseases
Intervention groups
Control group: 10 patients are injected with triamcinolone 5 times with an interval of 1 month. Intervention group: 10 patients are injected 5 times with an interval of 1 month under conditioned medium derived from Wharton's jelly mesenchymal stem cells. Intervention group: 10 patients are injected 5 times with an interval of 1 month with extracellular vesicles derived from Wharton's jelly mesenchymal stem cells.
Main outcome variables
Response to treatment, The amount of hair loss
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046282N29
Registration date:2023-05-06, 1402/02/16
Registration timing:prospective
Last update:2023-05-06, 1402/02/16
Update count:0
Registration date
2023-05-06, 1402/02/16
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
2023-05-10, 1402/02/20
Expected recruitment end date
2023-09-11, 1402/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of conditioned medium derived from Wharton's jelly mesenchymal stem cells, extracellular vesicles derived from Wharton's jelly and triamcinolone in the treatment of lichen Plano Pilaris
Public title
Comparing the effectiveness of two cell products and triamcinolone drug in the treatment of lichen planopillaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-60 years
Lichen planopilaris disease has been proven
Exclusion criteria:
breastfeeding
pregnancy
Infectious diseases
Age
From 18 years old to 60 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
The product is used for injection in a syringe covered with aluminum foil. The participant and the data analyst will not know about the intervention groups.
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
2023-04-10, 1402/01/21
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1402.024
Health conditions studied
1
Description of health condition studied
Lichen Planopilaris
ICD-10 code
L66
ICD-10 code description
Cicatricial alopecia [scarring hair loss]
Primary outcomes
1
Description
Response to treatment
Timepoint
0 and 6 months after the start of the study
Method of measurement
Lichen plano pilaris activity index
2
Description
The amount of hair loss
Timepoint
Before starting treatment and one month after the end of the treatment period
Method of measurement
Trichoscan
Secondary outcomes
1
Description
The level of satisfaction with treatment qualitatively
Timepoint
2 and 6 months after the start of treatment
Method of measurement
In the qualitative questionnaire (excellent effect, good, medium, low, ineffective)
2
Description
side effects
Timepoint
Before starting treatment and one month after the end of the treatment period
Method of measurement
Questionnaire and visit
3
Description
effectiveness
Timepoint
Before starting treatment and one month after the end of the treatment period
Method of measurement
Questionnaire and visit
Intervention groups
1
Description
Control group: 10 patients were injected with 3 cc of triamcinolone (Jaber Ebne Hayyan company) 5 times with a 1-month interval.
Category
Treatment - Other
2
Description
Intervention group: 10 patients are injected with 3 cc of mesenchymal stem cell medium conditioned by Wharton jelly (Zist Sakht Bonyan Pars company) 5 times at 1 month intervals.
Category
Treatment - Other
3
Description
Intervention group: 10 patients are injected with 3 cc of extracellular vesicles derived from Wharton jelly mesenchymal stem cells (Zist Sakht Bonyan Pars company) 5 times with an interval of 1 month.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin and Stem cell Research Center Clinic, 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
nilforoosh@sina.tums.ac.ir
Sponsors / Funding sources
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 3698
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
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
nilforoosh@sina.tums.ac.ir
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