The purpose of the study is to evaluate the efficacy of skin fibroblasts in the treatment of lesions related to the skin aging. The volunteer’s number is referring to the center of skin and stem cell research with a moderate wrinkle (degree of 3 and 4 Glogue scale) contains 16 people.
At first, the biometric parameters in patients face should be estimated before intervention, then a biopsy will be taken from back region of the patients ear and the dermal fibroblast cells will be isolated, cultured and proliferated for three times. Each time, 10 million cells will be injected on each side of nasolabial fold for three times within 2 weeks intervals. After 1, 3 and 6 months from intervention, Patients will be checked in order of biometric parameters and their information will be recorded and analyzed.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201506271159N17
Registration date:2017-09-15, 1396/06/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-15, 1396/06/24
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
Skin and Stem Cell Research Center of Tehran University and Medical Sciences
Expected recruitment start date
2016-10-06, 1395/07/15
Expected recruitment end date
2017-10-07, 1396/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Transplantation of autologous skin fibroblast cells for treatment of nasolabial wrinkles
Public title
Efficacy assessment of cell therapy with autologous fibroblast in skin aging
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age about 35 to 55 years old;- Patients with mild to moderate wrinkles according to Glogue scale I-III; No coagulation disorders and use of anti coagulated drugs; No infection in treated site; No fever able diseases; No chronic liver diseases; No pregnancy or breast-feeding; Having no anatomic disorder in face; 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
1-2
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
2014-09-29, 1393/07/07
Ethics committee reference number
1502/130/ص/93
Health conditions studied
1
Description of health condition studied
Face wrinkles
ICD-10 code
L98.8
ICD-10 code description
Other specified disorders of skin and subcutaneous tissue
Primary outcomes
1
Description
Severity of face wrinkles
Timepoint
1- 3 - 6 Month after cell therapy
Method of measurement
Biometry with visioface & skin sonography
Secondary outcomes
empty
Intervention groups
1
Description
First of all, fibroblast cells are isolated from biopsy of back region of patient’s ear, then ten million cells will be injected on each side of nasolabial fold for three times within 2 weeks interval. At the end, the rate of nasolabial fold improvement is estimated.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin and Stem Cell Research Center of Tehran University of Medical sciences
Full name of responsible person
Dr Mohammad Ali Nilforoushzadeh
Street address
Skin and Stemcell Research Center, Maryam aley, South kamraneye, Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Skin and Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, Iran
Full name of responsible person
Dr Mohammad Ali Nilforoushzadeh
Street address
Skin and Stemcell Research Center, Maryam aley, South kamraneye, Tehran, Iran
City
Tehran
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, Maryam aley, South kamraneye, Tehran, Iran
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 and Stem Cell Research Center of Tehran University of Medical sciences
Full name of responsible person
Sona Zare
Position
PhD/Laboratory manager
Other areas of specialty/work
Street address
Skin and Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, Iran
City
Tehran
Postal code
1937957511
Phone
+98 21 2220 1710
Fax
Email
sonazarebio@gmail.com
Web page address
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
Dr. Mohammadali Nilforoushzade
Position
Chife of Center / Dermatologist
Other areas of specialty/work
Street address
Skin and Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, Iran
City
Tehran
Postal code
1937957511
Phone
+98 21 2220 1710
Fax
Email
dr_nilforoush@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Skin and Stem Cell Research Center of Tehran University of Medical Science
Full name of responsible person
Sona Zare
Position
PhD/ Laboratory manager
Other areas of specialty/work
Street address
Skin and Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, Iran
City
Tehran
Postal code
1937957511
Phone
+98 21 2220 1710
Fax
Email
sonazarebio@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)