Comparison between efficacy of SVF (Stromal-Vascular Fraction) on nanofat effect with nanofat on healing of acne scar
Design
This study is performed on 10 patients with acne scars. After obtaining sufficient anesthesia, the treatment areas of the patients' scars on both sides of the face are treated with nanofiber. Immediately after the nanowire, one side of the patient's face (intervention group) is injected with adipose tissue-derived vascular stromal cells, and the other side of the face (control group) is injected with nanofeed. All patients are photographed by digital camera before treatment and in each visit. To determine the extent of improvement and compare the two sides of the face, 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 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 nanofat, SVF cells are injected on one side of the face and nothing is injected on the other side of the scar area.
Participants/Inclusion and exclusion criteria
Inclusion criteria: two to three acne scars. Exclusion criteria: Age under 18, family history of bleeding or coagulant diseases, use of anticoagulants or steroids, blood hemoglobin less than 10 and platelet count less than 150, presence of active skin or systemic infection, malignancy or history of receiving chemotherapy , Breastfeeding or pregnancy.
Intervention groups
Intervention group: One side of the face is treated with nanoparticles and vascular stromal cells derived from adipose tissue by injection. Control group: The other side of the face is treated with Nanoft.
Main outcome variables
scar's surface; side effects; patient's satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200127046282N7
Registration date:2022-03-26, 1401/01/06
Registration timing:prospective
Last update:2022-03-26, 1401/01/06
Update count:0
Registration date
2022-03-26, 1401/01/06
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
2022-04-19, 1401/01/30
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between efficacy of SVF (Stromal-Vascular Fraction) on nanofat effect with nanofat on healing of acne scar
Public title
Comparison between efficacy of SVF on nanofat effect with nanofat on healing of acne scar
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Acne scar grade 2 to 3 skin
Exclusion criteria:
Age under 18 years
Family history of bleeding or coagulant diseases
Taking anticoagulants or steroids
Blood hemoglobin less than 10 and platelet count less than 150
Existence of active skin or systemic infection
Having a malignancy or a history of receiving chemotherapy
Breastfeeding or pregnancy
Age
From 18 years old to 50 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients and physicians will not know the type of treatment, but the evaluator will know the type of patient treatment. Therefore, the study will be conducted blindly.
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
Tehran University of Medical Sciences, Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1937957511
Approval date
2021-09-22, 1400/06/31
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.711
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: (Other side of face) After sufficient anesthesia, treatment with nanofat.
Category
Treatment - Other
2
Description
Intervention group: One side of the face after being anesthetized, is first treated with nanofat, and then adipose derived Stromal Vascular Fraction (SVF) cells is injected in the scars.
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
Elham Behrangi
Street address
No 4, Maryam Alley, South Kamraniyeh Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2665 7438
Email
elham.behrangi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Skin and Stem Cell Research Center, 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
nilforoosh@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
Skin and Stem Cell Research Center, 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
Elham Behrangi
Position
assistant 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
elham.behrangi@gmail.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