Evaluation the effect of adipose derived stem cells conditioned medium (ADSC-CM) on rejuvenation after resurfacing with ablative fractional carbon dioxide laser
Evaluation the effect of adipose derived stem cells conditioned medium (ADSC-CM) on rejuvenation after resurfacing with ablative fractional carbon dioxide laser
Design
Clinical trial with a control group and an intervention group, with parallel groups, double-blind, randomized based on random number table, phase 1 on 10 patients with moderate and severe wrinkles
Settings and conduct
This project is carried out in the Dermatology and Stem Cell Research Center of Tehran University of Medical Sciences. One group is treated with laser and adipose derived stem cells conditioned medium topically and the other group is treated with laser and PRP topically.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 20-60; Having moderate wrinkles on the face. Exclusion criteria: Pregnancy and breastfeeding; Active infection in face; Using any injectable fillers on the face in the last six months
Intervention groups
Intervention group: A group treated with laser and adipose derived stem cells conditioned medium is placed topically. Control group: The other group is treated with laser and PRP topically.
Main outcome variables
The amount of wrinkles; side effects; patient's satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046282N19
Registration date:2022-06-06, 1401/03/16
Registration timing:prospective
Last update:2022-06-06, 1401/03/16
Update count:0
Registration date
2022-06-06, 1401/03/16
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
2022-06-20, 1401/03/30
Expected recruitment end date
2022-09-21, 1401/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of adipose derived stem cells conditioned medium (ADSC-CM) on rejuvenation after resurfacing with ablative fractional carbon dioxide laser
Public title
Evaluation of clinical improvement of conditioned media of adipose derived stem cells in the treatment of wrinkles in the facial skin
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-60
Having middle wrinkles in face region
Exclusion criteria:
Pregnancy and breastfeeding
History of cancer
Patients with a new history of gel and Botox injections
People with Mental Disorders
Active infection in the face
Age
From 20 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
In each session, immediately after fractional laser, adipose-derived stem cells conditioned medium are used in one group and PRP is used in the other group after laser.
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
2022-02-21, 1400/12/02
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1412
Health conditions studied
1
Description of health condition studied
Skin aging
ICD-10 code
L90.9
ICD-10 code description
Atrophic disorder of skin
Primary outcomes
1
Description
The amount of wrinkles
Timepoint
Before treatment and six month after the last session
Method of measurement
Visio face
Secondary outcomes
1
Description
Inflammation
Timepoint
After each session
Method of measurement
Questionnaire and visit
2
Description
Intensity of pain
Timepoint
Treatment time
Method of measurement
Questionnaire and visit
Intervention groups
1
Description
Intervention group: After adequate anesthesia, a group is first treated with laser and then the stem cells conditioned medium is applied topically to the wrinkle site for one hour. This method is repeated 3 times with 4 week intervals.
Category
Treatment - Other
2
Description
Control group: After adequate anesthesia, a group is first treated with laser and then the PRP is applied topically to the wrinkle site for one hour. This method is repeated 3 times with 4 week intervals.
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
4No 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