Objectives: To evaluate the efficacy, durability and adverse events of autologous fibroblast transplantation in wrinkle and acne scar. Design: open-label, non-randomized phase II, single center clinical trial. Sample size: 60 patients. Participants: Age of at least 18 years old; wrinkle or acne scar score of at-least 2 out 7. Exclusion Criteria: Pregnancy or lactation; filler, botolonium toxin or laser during past 6 months. Primary Outcome: Decrease in wrinkle or scar score. Secondary outcome: Safety of the intervention. Intervention: A small piece of retroauricular site of patient is taken, fibroblasts are isolated and cultured. Cultured fibroblasts are injected into intradermal of treatment sites in 3 sessions and 4 weeks intervals. Patients were followed 2, 6 and 12 months after 3rd injection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201508201031N15
Registration date:2016-08-04, 1395/05/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-04, 1395/05/14
Registrant information
Name
Nasser Aghdami
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2356 2000
Email address
nasser.aghdami@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology
Expected recruitment start date
2008-08-21, 1387/05/31
Expected recruitment end date
2010-10-22, 1389/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the efficacy rate of autologous fibroblast transplantation in facial contour deformities
Public title
Facial contour deformities
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Age>18 years; facial wrinkle or acne scar of at-least 2 out 7; Ability to sign informed consent.
Exclusion Criteria: Known allergy or sensitivity to collagen fillers; history of soft tissue augmentation to the area during last 6 months; autologous fat transfer in the last 6 months; facial Kaposi sarcoma; active skin diseases or inflammation of the treatment area; Silicon injection in treatment site; pregnancy or lactating; systemic immunosuppressive or steroid drugs during past 6 months; current anticoagulant therapy; disease of connective tissue; malignant disease; Positive HIV, HBV, HCV
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
No other features
Secondary Ids
1
Registry name
clinicaltrials.gov
Secondary trial Id
NCT 01115634
Registration date
2010-01-05, 1388/10/15
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Royan infertility institute
Street address
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
012/87/پ
Health conditions studied
1
Description of health condition studied
Acne Scar
ICD-10 code
L90.5
ICD-10 code description
Scar conditions and fibrosis of skin
2
Description of health condition studied
Wrinkle
ICD-10 code
L98.9
ICD-10 code description
Disorder of skin and subcutaneous tissue, unspecified
Primary outcomes
1
Description
Decrease in scar and wrinkle score
Timepoint
2, 6 and 12 months after cell injection
Method of measurement
Based on evaluator assessment score according to standardized 7-point grading
Secondary outcomes
1
Description
Safety
Timepoint
2, 6 and 12 months after cell injection
Method of measurement
Assessments based on evaluator and subject
Intervention groups
1
Description
3 sessions of intradermal injection of autologous cultured fibroblast 0.1 ml along each cm with 4 weeks intervals
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin Clinic of Royan Institute
Full name of responsible person
Hamid Gourabi
Street address
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Royan Institute
Full name of responsible person
Hamid Gourabi
Street address
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Royan Institute
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
Royan Institute
Full name of responsible person
Amir Bajouri
Position
M.D/ Researcher
Other areas of specialty/work
Street address
Eastern Hafez St, Northern Banihashem St, 45 m Resalat highway
City
Tehran
Postal code
Phone
+98 21 2251 8388
Fax
Email
bajouri_md@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Royan cell Therapy Center
Full name of responsible person
Nasser Aghdami
Position
M.D, PhD
Other areas of specialty/work
Street address
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Postal code
Phone
+98 21 2356 2000
Fax
Email
nasser.aghdami@royaninstitute.org
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Royan Institute
Full name of responsible person
Hoda Madani
Position
Researcher
Other areas of specialty/work
Street address
Royan Institute, Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Postal code
Phone
+98 21 2251 8388
Fax
+98 21 2251 6465
Email
hoda62_m@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)