Efficacy and safety of human dermal fibroblasts cultured in clinical-grade large scale cultured system compared to placebo in treatment of nasolabial folds : A randomized, placebo controlled phase 3, parallel, double blinded clinical trial
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Protocol summary
Study site: Center for Research and Training in Skin Diseases and Leprosy, Tehran, Iran. After including the eligible patients and receiving their written consent, wrinkle assessment are evaluated by the physician and the patient. 2D imaging and ultrasonographic findings are recorded and the sickness of epiderm and derm plus dermal density will be measured. The patients and outcome assessors are blinded to the interventions.
Study site: Royan instirute, Tehran, Iran. After including the eligible patients and receiving their written consent, wrinkle assessment are evaluated by the physician and the patient. 2D imaging and ultrasonographic findings are recorded and the sickness of epiderm and derm plus dermal density will be measured. The patients and outcome assessors are blinded to the interventions.
Study site: Center for Research and Training in Skin Diseases and LeprosyRoyan instirute, Tehran, Iran. After including the eligible patients and receiving their written consent, wrinkle assessment are evaluated by the physician and the patient. 2D imaging and ultrasonographic findings are recorded and the sickness of epiderm and derm plus dermal density will be measured. The patients and outcome assessors are blinded to the interventions.
مطالعه در مرکز آموزش و پژوهش بیماری های پوست و جذام تهران. پس از ورود بیمار به مطالعه بر اساس معیارهای ورود و عدم ورود و تکمیل فرم رضایت آگاهانه، نمره ارزیابی پزشک از میزان چین و چروک و نمره ارزیابی خود بیمار ثبت می گردد. سپس از صورت بیمار عکس دو بعدی گرفته می شود تستهای مربوط به شاخصهای اولترا سونوگرافیکی در منطقه نازولیبال برای بیمار انجام شده و اندازه های مربوط به ضخامت اپیدرم، درم و دانسیته درم ثبت می گردد. مطالعه دو سوکور با کورسازی شرکت کننده و ارزیابی کننده پیامد است
محل مطالعه در پژوهشگاه رویان تهران. پس از ورود بیمار به مطالعه بر اساس معیارهای ورود و عدم ورود و تکمیل فرم رضایت آگاهانه، نمره ارزیابی پزشک از میزان چین و چروک و نمره ارزیابی خود بیمار ثبت می گردد. سپس از صورت بیمار عکس دو بعدی گرفته می شود تستهای مربوط به شاخصهای اولترا سونوگرافیکی در منطقه نازولیبال برای بیمار انجام شده و اندازه های مربوط به ضخامت اپیدرم، درم و دانسیته درم ثبت می گردد. مطالعه دو سوکور با کورسازی شرکت کننده و ارزیابی کننده پیامد است
محل مطالعه در مرکز آموزش و پژوهش بیماری های پوست و جذامپژوهشگاه رویان تهران. پس از ورود بیمار به مطالعه بر اساس معیارهای ورود و عدم ورود و تکمیل فرم رضایت آگاهانه، نمره ارزیابی پزشک از میزان چین و چروک و نمره ارزیابی خود بیمار ثبت می گردد. سپس از صورت بیمار عکس دو بعدی گرفته می شود تستهای مربوط به شاخصهای اولترا سونوگرافیکی در منطقه نازولیبال برای بیمار انجام شده و اندازه های مربوط به ضخامت اپیدرم، درم و دانسیته درم ثبت می گردد. مطالعه دو سوکور با کورسازی شرکت کننده و ارزیابی کننده پیامد است
General information
2018-06-05, 1397/03/15
2019-02-04, 1397/11/15
20182019-0602-0504 00:00:00
2019-06-05, 1398/03/15
2020-02-04, 1398/11/15
20192020-0602-0504 00:00:00
Recruitment centers
#1
Name of recruitment center - English: Center for Research and Training in Skin Diseases and Leprosy (CRTSDL)
Name of recruitment center - Persian: مرکز آموزش و پژوهش بیماری های پوست و جذام
Full name of responsible person - English: Alireza Firooz
Full name of responsible person - Persian: علیزضا فیروز
Street address - English: Taleqani Ave. No 415
Street address - Persian: خیابان طالقانی،شماره 415
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1416613675
Phone: +98 21 8896 8190
Fax: +98 21 8896 3804
Email: firozali@tums.ac.ir
Web page address: http://crtsdl.tums.ac.ir/index.php/en/
Name of recruitment center - English: Royan Institute
Name of recruitment center - Persian: پژوهشگاه رویان
Full name of responsible person - English: Saeed Shafieyan
Full name of responsible person - Persian: سعید شفیعیان
Street address - English: Royan Ave.,East Hafez St., Banihashem St
Street address - Persian: خیابان بنی هاشم، حافظ شرقی، بلوار رویان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1665664511
Phone: +98 21 2356 2171
Fax:
Email: sshafiiyan@yahoo.com
Web page address: http://www.royaninstitute.org/cmsen/index.php
Name of recruitment center - English: Center for Research and Training in Skin Diseases and Leprosy (CRTSDL)Royan Institute Name of recruitment center - Persian: مرکز آموزش و پژوهش بیماری های پوست و جذامپژوهشگاه رویان Full name of responsible person - English: Alireza FiroozSaeed Shafieyan Full name of responsible person - Persian: علیزضا فیروزسعید شفیعیان Street address - English: Taleqani AveRoyan Ave.,East Hafez St. No 415, Banihashem St Street address - Persian: خیابان طالقانیبنی هاشم،شماره 415 حافظ شرقی، بلوار رویان City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 14166136751665664511 Phone: +98 21 8896 81902356 2171 Fax: +98 21 8896 3804 Email: firozalisshafiiyan@tums.ac.iryahoo.com Web page address: http://crtsdl.tums.ac.irwww.royaninstitute.org/cmsen/index.php/en/
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Royan Institute
Name of organization / entity - Persian: پژوهشگاه رویان
Full name of responsible person - English: Nasser Aghdami
Full name of responsible person - Persian: ناصر اقدمی
Street address - English: Resalat Highway
Street address - Persian: بزرگراه رسالت
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 14669887
Phone: +98 21 8856 1575
Fax: +98 21 8856 1575
Email: nasser.aghdami@royaninstitute.org
Web page address: http://www.royaninstitute.org
contact.organization_id: Name of organization / entity - English: Royan Institute Name of organization / entity - Persian: پژوهشگاه رویان Full name of responsible person - English: Nasser Aghdami Full name of responsible person - Persian: ناصر اقدمی Street address - English: Resalat Highway Street address - Persian: بزرگراه رسالت City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 14669887 Phone: +98 21 8856 1575 Fax: +98 21 8856 1575 Email: nasser.aghdami@royaninstitute.org Web page address: http://www.royaninstitute.org
Yes
empty
1
50
empty
50
Public
empty
public
Domestic
empty
domestic
Other
empty
other
Royan Institute
empty
Royan Institute
پژوهشگاه رویان
empty
پژوهشگاه رویان
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Alireza Firooz
Full name of responsible person - Persian: علیرضا فیروز
Position - English: Professor
Position - Persian: استاد
Latest degree: specialist
Area of specialty/work: 42
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No. 415, Taleqni Ave
Street address - Persian: خیابان طالقانی - نبش خیابان شهید نادری - شماره ۴۱۵
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1416613675
Phone: +98 88972220
Mobile: +98 912 109 4901
Fax:
Email: FIROZALI@TUMS.AC.IR
Web page address:
contact.organization_id:
Name of organization / entity - English: Royan Institute for Stem Cell Biology and Technology
Name of organization / entity - Persian: پژوهشکده زیستشناسی و فناوری سلولهای بنیادی رویان
Full name of responsible person - English: Saeid Shafieian
Full name of responsible person - Persian: سعید شفیعیان
Position - English: Scientific Head of Skin Cell Research and Therapy Center, Regenerative Medicine Department
Position - Persian: ریاست مرکز پژوهش و درمان سلولهای پوستی، دپارتمان پزشکی ترمیمی
Latest degree: specialist
Area of specialty/work: 42
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Royan Ave.,East Hafez St., Banihashem St.
Street address - Persian: خیابان بنی هاشم ، حافظ شرقی، خیابان رویان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1665664511
Phone: +98 21 2356 2171
Mobile: +98 912
Fax:
Email: sshafiiyan@yahoo.com
Web page address: http://www.royaninstitute.org/cmsen/index.php
contact.organization_id: Name of organization / entity - English: Royan Institute for Stem Cell Biology and Technology Name of organization / entity - Persian: پژوهشکده زیستشناسی و فناوری سلولهای بنیادی رویان Full name of responsible person - English: Alireza FiroozSaeid Shafieian Full name of responsible person - Persian: علیرضا فیروزسعید شفیعیان Position - English: ProfessorScientific Head of Skin Cell Research and Therapy Center, Regenerative Medicine Department Position - Persian: استادریاست مرکز پژوهش و درمان سلولهای پوستی، دپارتمان پزشکی ترمیمی Latest degree: specialist Area of specialty/work: 42 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: NoRoyan Ave.,East Hafez St. 415, Taleqni AveBanihashem St. Street address - Persian: خیابان طالقانی - نبشبنی هاشم ، حافظ شرقی، خیابان شهید نادری - شماره ۴۱۵رویان City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 14166136751665664511 Phone: +98 8897222021 2356 2171 Mobile: +98 912 109 4901 Fax: Email: FIROZALIsshafiiyan@TUMS.AC.IRyahoo.com Web page address: http://www.royaninstitute.org/cmsen/index.php
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Alireza Firooz
Full name of responsible person - Persian: علیرضا فیروز
Position - English: Professor
Position - Persian: استاد
Latest degree: specialist
Area of specialty/work: 42
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No. 415, Taleqni Ave
Street address - Persian: خیابان طالقانی - نبش خیابان شهید نادری - شماره ۴۱۵
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1416613675
Phone: +98 21 8897 2220
Mobile: +98 912 109 4901
Fax:
Email: FIROZALI@TUMS.AC.IR
Web page address:
contact.organization_id:
Name of organization / entity - English: Royan Institute for Stem Cell Biology and Technology
Name of organization / entity - Persian: پژوهشکده زیستشناسی و فناوری سلولهای بنیادی رویان
Full name of responsible person - English: Saeid Shafieian
Full name of responsible person - Persian: سعید شفیعیان
Position - English: Scientific Head of Skin Cell Research and Therapy Center, Regenerative Medicine Department
Position - Persian: ریاست مرکز پژوهش و درمان سلولهای پوستی، دپارتمان پزشکی ترمیمی
Latest degree: specialist
Area of specialty/work: 42
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Royan Ave.,East Hafez St., Banihashem St.
Street address - Persian: خیابان بنی هاشم ، حافظ شرقی، خیابان رویان
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1665664511
Phone: +98 21 2356 2171
Mobile: +98 912
Fax:
Email: sshafiiyan@yahoo.com
Web page address: http://www.royaninstitute.org/cmsen/index.php
contact.organization_id: Name of organization / entity - English: Royan Institute for Stem Cell Biology and Technology Name of organization / entity - Persian: پژوهشکده زیستشناسی و فناوری سلولهای بنیادی رویان Full name of responsible person - English: Alireza FiroozSaeid Shafieian Full name of responsible person - Persian: علیرضا فیروزسعید شفیعیان Position - English: ProfessorScientific Head of Skin Cell Research and Therapy Center, Regenerative Medicine Department Position - Persian: استادریاست مرکز پژوهش و درمان سلولهای پوستی، دپارتمان پزشکی ترمیمی Latest degree: specialist Area of specialty/work: 42 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: NoRoyan Ave.,East Hafez St. 415, Taleqni AveBanihashem St. Street address - Persian: خیابان طالقانی - نبشبنی هاشم ، حافظ شرقی، خیابان شهید نادری - شماره ۴۱۵رویان City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 14166136751665664511 Phone: +98 21 8897 22202356 2171 Mobile: +98 912 109 4901 Fax: Email: FIROZALIsshafiiyan@TUMS.AC.IRyahoo.com Web page address: http://www.royaninstitute.org/cmsen/index.php
Protocol summary
Study aim
To determine efficacy and safety of cultured fibroblasts in the treatment of nasolabial folds
Study site: Royan instirute, Tehran, Iran. After including the eligible patients and receiving their written consent, wrinkle assessment are evaluated by the physician and the patient. 2D imaging and ultrasonographic findings are recorded and the sickness of epiderm and derm plus dermal density will be measured. The patients and outcome assessors are blinded to the interventions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 30 to 60 years, nasolabial folds, WAS 3to5, length of wrinkle line 12 to 15 cm, written consent to participate/Exclusion criteria: chronic disease,pregnancy , lactation, cancer, HIV, HCV or HBV positive, history of cell therapy, skin interventions in the last 6 months, history of organ transplantation or blood transfusion, immunosuppressive or cytotoxic use in the last 6 months, history of skin mass or benign skin disease, history of anticoagulants use, mesotherapy or skin surgery, injection of permanent fillers, injection of botulinum before the end of efficacy time, HSV history, active infection at the site, heavy diet for weight change, collagen or fibroblast producing diseases, allergy to bovine products, allergy to streptomycin or penicillin, using retinoid drugs during the last 6 months, hypo/hyperthyroidism, history of severe mental problems
Intervention groups
control group:placebo 0.1 ml/cm in each injection
Intervention group: Fibroblast 20millions of cells/ml involume of 0.1ml/cm in each injection
Main outcome variables
remission rate (with at least 2 units change in WAS) based on physician's evaluation and images comparison before and 9 months after the injection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100127003200N5
Registration date:2018-06-10, 1397/03/20
Registration timing:prospective
Last update:2018-10-25, 1397/08/03
Update count:1
Registration date
2018-06-10, 1397/03/20
Registrant information
Name
Kazem Heidari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6649 5948
Email address
k_heidari@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2020-02-04, 1398/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy and safety of human dermal fibroblasts cultured in clinical-grade large scale cultured system compared to placebo in treatment of nasolabial folds : A randomized, placebo controlled phase 3, parallel, double blinded clinical trial
Public title
Effects of cultured fibroblast on reducing nasolabial folds
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 30-60 years
Having nasolabial folds
Wrinkle Assessment Scale between 3 to 5
Nasolabial fold line length between 12-15 cm
Written consent to participate and willingness to attend in regular treatment / follow up visits
Exclusion criteria:
Having a known chronic disease
pregnancy or plan to be pregnant during the next 5 years
Lactation
history of cancer or chemotherapy
Having viral disease: HIV, HBV or HCV
History of cell therapy
History of lipotransfer at the nasolabial region
UV, laser or PRP interventions in the last 6 months
History of organ transplantation or blood transfusion
History of allergy to anesthetic drugs
History of using immunosuppresive or cytotoxic drugs in the last 6 months
History of Skin mass or benign skin diseases
History of anticoagulant use
Mesotherapy or skin surgery
Injection of permanent fillers
Injection of botulinum or fillers before the end of efficacy time
HSV history
Active infection at the injection site
Diabetes
Being under heavy diet for weigh loss or weight gain
Collagen of fibroblast producing diseases like marfan syndrome or epidermolysis bullosa
History of allergy to bovine products
History of allergy to streptomycin or penicillin
Using retinoid drugs during the last 6 months
Uncontrolled hypothyroidism or hyperthyroidism
History of severe mental problems like depression, anxiety disorders or bipolar disorders
Age
From 30 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization list will be generated using online source: https://www.sealedenvelope.com. Block randomization with block size 4 results in generation of 15 blocks. After the randomization list generation, every patient will be assigned a unique identification code.
All the staff conducting the study will be blinded to randomization list. Opaque sealed consecutively numbered envelopes will be used for the allocation concealment process.Each envelope will be opened after assuring eligibility of the participant and giving written signed consent form.
Blinding (investigator's opinion)
Double blinded
Blinding description
patients will receive similar 100 units, gauge 30 syringes in both groups.
Those who conduct the injections are different form those who conduct the examinations and patients' assessments.
The packages of investigational products will be labelled by unique codes.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Vice chancellor for research, Tehran University of Medical Sciences
Street address
Qods street
City
Tehran
Province
Tehran
Postal code
1346694133
Approval date
2018-04-18, 1397/01/29
Ethics committee reference number
IR.TUMS.VCR.REC.1397.091
Health conditions studied
1
Description of health condition studied
Nasolabial folds
ICD-10 code
L98.8
ICD-10 code description
Other specified disorders of the skin and subcutaneous tissue
Primary outcomes
1
Description
Remission rate
Timepoint
Before and nine months after injection
Method of measurement
Wrinkle assessment scale
Secondary outcomes
1
Description
Wrinkle Assessment Scale
Timepoint
Before and weeks 20, 32 and 44 after injection
Method of measurement
score 1 to 5 regarding image comparisons before and after injection
2
Description
Subject Self-assessment of wrinkle
Timepoint
Before and weeks 20, 32 and 44 after injection
Method of measurement
Subject Self-assessment Scale of wrinkle: scroe -2 to +2
3
Description
Length, depth and volume of wrinkle
Timepoint
Before and weeks 20, 32 and 44 after injection
Method of measurement
Two dimensional imaging by VisioFace
4
Description
Thickness of epiderm and derm and dermal density
Timepoint
Before and weeks 20, 32 and 44 after injection
Method of measurement
Ultrasonographic findings
5
Description
Adverse events
Timepoint
Every time happens
Method of measurement
From adverse events list
Intervention groups
1
Description
Control group: Placebo injection 0.1 ml/cm in each injection: three injections in 4 consecutive weeks
Category
Placebo
2
Description
Intervention group: Fibroblast injection 20 millions of cells in 0.1 ml/cm in each injection: three injections in 4 consecutive weeks
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Royan Institute
Full name of responsible person
Saeed Shafieyan
Street address
Royan Ave.,East Hafez St., Banihashem St
City
Tehran
Province
Tehran
Postal code
1665664511
Phone
+98 21 2356 2171
Fax
Email
sshafiiyan@yahoo.com
Web page address
http://www.royaninstitute.org/cmsen/index.php
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Barkat pharmaceutical group
Full name of responsible person
Nasser Aghdami
Street address
No. 11, 5th Alley, Bucharest Ave., Argentina Sq
City
Tehran
Province
Tehran
Postal code
1111111111
Phone
+98 21 8848 0161
Fax
+98 21 8848 0160
Email
info@bpharmed.com
Web page address
http://www.bpharmed.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Barkat pharmaceutical group
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry
Person responsible for general inquiries
Contact
Name of organization / entity
Royan Institute for Stem Cell Biology and Technology
Full name of responsible person
Saeid Shafieian
Position
Scientific Head of Skin Cell Research and Therapy Center, Regenerative Medicine Department
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Royan Ave.,East Hafez St., Banihashem St.
City
Tehran
Province
Tehran
Postal code
1665664511
Phone
+98 21 2356 2171
Fax
Email
sshafiiyan@yahoo.com
Web page address
http://www.royaninstitute.org/cmsen/index.php
Person responsible for scientific inquiries
Contact
Name of organization / entity
Royan Institute for Stem Cell Biology and Technology
Full name of responsible person
Saeid Shafieian
Position
Scientific Head of Skin Cell Research and Therapy Center, Regenerative Medicine Department
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Royan Ave.,East Hafez St., Banihashem St.
City
Tehran
Province
Tehran
Postal code
1665664511
Phone
+98 21 2356 2171
Fax
Email
sshafiiyan@yahoo.com
Web page address
http://www.royaninstitute.org/cmsen/index.php
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Kazem Heidari
Position
Non faculty member PhD
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
16th Azar street, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1346694133
Phone
+98 21 4415 1015
Fax
+98 21 8896 3546
Email
k_heidari@razi.tums.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available