Efficacy assessment of adipose drived stem cells in nasolabial fold wrinkle is the aim of this study. Firstly biometric parameters of patient face before intervention would be measured and then about 100cc of abdominal fat would be taken via liposuction technique being suspended and finally the suspension of adipose derived stem cells as in Stromal Vascular Fractioned(SVF) would be injected in patient nasolabial fold.
After 1,3,6 month from injection, biometric parameters will be assessed for second time to estimate healing rate. Inclusion criteria are as to have 35 to 55 years old, no systemic disease, have nasolabial wrinkle type 2,3,4.
Exclusion criteria are to have many or huge wrinkles and to be under any intervention in face before as gel injection and etc. Study Population group is from people reffering to skin and stem cell research center and sample size is 16 person. our intervention is injection of adipose derived stem cells in nasolabial fold and to compare wrinkle rate after intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014100719432N1
Registration date:2015-05-31, 1394/03/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-05-31, 1394/03/10
Registrant information
Name
Mohammadamir Amirkhani
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 1710
Email address
amirkhani@health.gov.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical sciences
Expected recruitment start date
2014-11-22, 1393/09/01
Expected recruitment end date
2014-12-21, 1393/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy assessment of adipose drive stem cell in nasolabial fold wrinkles
Public title
Efficacy assessment of cell therapy in skin aging
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age about 35 to 55 years old;
Having no anatomic disorder in face;
Wrinkle type between grade 2 to 4;
Normal mental health;
Having a good cooperation with research team;
Exclusion criteria:
being smokers or drinkers;
any past skin intervention in face;
Having many wrinkles on the face;
type of 1 or 5 of wrinkle scoring;
having a mental disorder;
having an obsessed disorder;
having any skin disorder;
having any major disorder;
having a systemic disorder;
having an oral disorder;
Age
From 35 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Cross Qods st, Keshavarz Blvd, Tehran, Iran
City
Tehran
Postal code
Approval date
2014-09-07, 1393/06/16
Ethics committee reference number
130/1254/ص
Health conditions studied
1
Description of health condition studied
atrophic disorders of skin (aging)
ICD-10 code
L90.9
ICD-10 code description
Atrophic disorder of skin, unspecified
Primary outcomes
1
Description
Quantity of nasolabial fold wrinkle - Extension
Timepoint
1- 3 - 6 Month after cell therapy
Method of measurement
Biometry with visioface & skin sonography
2
Description
Quality of nasolabial fold wrinkle - deep
Timepoint
1 - 3 - 6 Mounth after intervention
Method of measurement
Visio face & skin sono
Secondary outcomes
1
Description
Color
Timepoint
1 - 3 - 6 Month after cell therapy
Method of measurement
Biometry with colorimeter
2
Description
Elastisity
Timepoint
1 - 3 - 6 Eounth after intervention
Method of measurement
MPA 9
Intervention groups
1
Description
2cc suspension of adipose drive stem cell (SVF) that made from 100 cc abdominal adipose will injected in nasolabial fold and the end, healing rate of nasolabial fold wrinkle will measured.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin & Stem Cell Research Center of Tehran University and Medical Sciences
Full name of responsible person
Dr Amirkhani PhD Condidate of center
Street address
Skin & Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Nilforoushzadhe
Street address
Skin & Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, Iran
City
Tehran
Grant name
ردیف متمرکز مرکز پوست
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
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Skin & Stem Cell Research Center of Tehran University of Medical sciences
Full name of responsible person
Dr. Mohammadamir Amirkhani
Position
Project Manager - Medical Doctor
Other areas of specialty/work
Street address
Skin & Stemcell Research Center, Maryam aley, South kamraneye, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2220 1710
Fax
+98 21 2220 1710
Email
amirkhani@health.gov.ir
Web page address
http://311.rc.research.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin & Stem Cell Research Center of Tehran University of Medical Science
Full name of responsible person
Dr. Mohammadali Nilforoushzade
Position
Chife of Center / Dermatologist
Other areas of specialty/work
Street address
Skin & Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2220 1710
Fax
+98 22201710
Email
dr_nilforoush@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Skin & Stem Cell Research Center of Tehran University of Medical sciences
Full name of responsible person
Dr. Mohammadamir Amirkhani
Position
Project Manager / Medical Doctor
Other areas of specialty/work
Street address
Skin & Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, Iran
City
Tehran
Postal code
Phone
+98 21 2220 1710
Fax
+98 21 2220 1710
Email
amirkhani@health.gov.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)