Investigating the safety and efficacy of Wharton's jelly mesenchymal stem cell secretome injection in combination with erbium laser compared to erbium laser alone in the treatment of facial atrophic scars (phase I and II clinical study)
Investigating the safety and efficacy of Wharton's jelly mesenchymal stem cell secretome injection in combination with erbium laser compared to erbium laser alone in the treatment of facial atrophic scars (phase I and II clinical study)
Design
This study is conducted on 15 patients with acne scars. After obtaining sufficient anesthesia, the scar treatment areas of patients on both sides of the face are treated with erbium laser. Immediately after the laser, one side of the patient's face (intervention group) is injected with conditioned medium, and the other side of the face (control group) is injected with normal saline.
Settings and conduct
This project is carried out in the Skin and Stem cell Research Center of Tehran University of Medical Sciences and without the patient's knowledge from the intervention groups, after the laser, one side of the face is injected with conditioned medium and the other side is injected with normal saline in the scar areas.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 25-45, having middle to severe atrophic scar in face region. Exclusion criteria: Pregnancy and breastfeeding, history of cancer, patients with active acne, people with Mental Disorders, active infection in the face
Intervention groups
Control group: (one side of the face) after sufficient anesthesia, it is treated with erbium laser. Intervention group: after sufficient anesthesia, one side of the face is first treated with laser, and then conditioned medium is injected on the scars.
Main outcome variables
scar's surface; side effects; patient's satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046282N44
Registration date:2024-06-15, 1403/03/26
Registration timing:prospective
Last update:2024-06-15, 1403/03/26
Update count:0
Registration date
2024-06-15, 1403/03/26
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
2024-06-19, 1403/03/30
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the safety and efficacy of Wharton's jelly mesenchymal stem cell secretome injection in combination with erbium laser compared to erbium laser alone in the treatment of facial atrophic scars (phase I and II clinical study)
Public title
Investigating secretome injection of mesenchymal stem cells with erbium laser in the treatment of facial atrophic scars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 25-45
Having middle to severe atrophic scar in face region
Exclusion criteria:
Pregnancy and breastfeeding
History of cancer
Patients with active acne
People with Mental Disorders
Active infection in the face
Age
From 25 years old to 45 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are entered into the treatment groups based on computer random selection with a ratio of 1 to 1. From a box with 60 sealed envelopes, one envelope is selected for each patient, which contains code A or B. (A → the first method and B → the second method)
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and doctors will not know about the study groups. Prepared syringe and normal saline with it will be covered with aluminum foil. 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 Committees of Research Institute for Oncology, Hematology and Cell Therapy - Tehran
Street address
Shariati Hospital, Research Institute for Oncology, Hematology and Cell Therapy
City
Tehran
Province
Tehran
Postal code
1937957511
Approval date
2023-06-14, 1402/03/24
Ethics committee reference number
IR.TUMS.HORCSCT.REC.1402.014
Health conditions studied
1
Description of health condition studied
atrophic scar
ICD-10 code
L90.5
ICD-10 code description
Scar conditions and fibrosis of skin
Primary outcomes
1
Description
Scar size
Timepoint
before and 3 month after the intervention
Method of measurement
visio face
Secondary outcomes
1
Description
Side effects
Timepoint
One week after treatment
Method of measurement
Questionnaire and visit
2
Description
Patient Satisfaction
Timepoint
Three month after treatment
Method of measurement
Questionnaire
Intervention groups
1
Description
Control group:(one side of the face) after sufficient anesthesia, it is treated with erbium laser and normal saline injection. This work will be done in three sessions with an interval of one month.
Category
Treatment - Other
2
Description
Intervention group: (one side of the face) after sufficient anesthesia, it is treated with erbium laser and condition medium (Zist Sakht Bonyan Pars Company, Sharif University of Technology) injection. This work will be done in three sessions with 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
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 Akbari Sari
Street address
No 4, Maryam Alley, South Kamraniyeh Street
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