Evaluation the effect of conditioned media of adipose derived stem cells (ADSC) on healing of scar after fractional Carbon Dioxide(CO2) laser resurfacing
Design
This pilot study on 10 patients with moderate and severe acne scarring done. At each session, after receiving adequate anesthetic, the scars of the patients are treated with Fractional Laser Co2 on both sides of the face.
In each session immediately after the laser, one side of the patient's face, the conditioned media of ADSC, and the other side of the face, the physiologic serum was applied locally to the scars area for one hour. This procedure is repeated 4 times at intervals of 4 weeks.All patients are photographed by digital camera before and after treatment.To determine the rate of improvement and compare two sides of the face at the end, patient photographs are reviewed by two blind dermatologist.Patient satisfaction is also recorded and the results are compared.
Settings and conduct
This design is done at the skin and stem cell research center of Tehran university of medical sciences and without the patient's knowledge, after the CO2 laser, one side of the face of conditioned media of ADSC and other side for blinding is used of the physiology serum in the scars.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 20-60; Developing middle to severe atrophic scars in face region. Exclusion criteria: Pregnancy and breastfeeding; Active infection in face; Using any local drugs on face except sun protection creams in last month
Intervention groups
First intervention group: One side of the face is treated with CO2 laser and conditioned media of adipose derived stem cells in the topical position. Second intervention group: The other side of the face is treated as a control group with CO2 laser and physiologic serum.
Main outcome variables
scar's surface; side effects; patient's satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080901001159N25
Registration date:2019-08-11, 1398/05/20
Registration timing:registered_while_recruiting
Last update:2019-08-11, 1398/05/20
Update count:0
Registration date
2019-08-11, 1398/05/20
Registrant information
Name
Mohamad Ali Nilforoushzadeh
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 5158
Email address
sdlrc@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-20, 1398/03/30
Expected recruitment end date
2019-08-21, 1398/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of conditioned media of adipose derived stem cells on healing of acne scar after fractional carbondioxide laser resurfacing
Public title
Evaluation the effect of conditioned media of adipose derived stem cells in the treatment of acne scars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-60
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 20 years old to 60 years old
Gender
Both
Phase
1
Groups that have been masked
Participant
Sample size
Target sample size:
10
More than 1 sample in each individual
Number of samples in each individual:
2
A half face will be considered as the control group and one half as an intervention group.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In each session, immediately after the laser on one side of the face, the conditioned media of adipose derived stem cells and the other side of the face saline solution is used topically on the scar.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1937957511
Approval date
2019-06-13, 1398/03/23
Ethics committee reference number
IR.TUMS.VCR.REC.1398.283
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 3month after the intervention
Method of measurement
visioface
2
Description
side effects
Timepoint
One week after session
Method of measurement
Questionnaire and visit
3
Description
Patient Satisfaction
Timepoint
Three and six months after the last treatment session
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Control group: (Other side of face) After sufficient anesthesia, first treatment with Fractional Laser Co2, and then physiological serum is applied topically to the site of the scars for one hour. This procedure is repeated 4 times with intervals of 4 weeks. .
Category
Treatment - Other
2
Description
Intervention group: One side of the face after being anesthetized, is first treated with Fractional Laser Co2, and then adipose conditioned media of adipose derived stem cells is applied topically to the scars for one hour.This procedure is repeated 4 times with intervals of 4 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics of Skin and Stem cell Research Center of Tehran University of Medical Sciences
Full name of responsible person
Fariba Jaffary
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
Fax
+98 21 2665 7438
Email
tmarkaz@yahoo.com
Web page address
http://skinstemcell.ir/
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 2251 5558
Fax
+98 21 2665 7438
Email
tmarkaz@yahoo.com
Web page address
http://skinstemcell.ir/
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
Mehrak Zare
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2223 9387
Email
exempt_36@yahoo.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 2223 9387
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
Mona mahmoudbeyk
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Reproductive Biology
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 5558
Email
mmahmoodbeyk@yahoo.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