Transplantation of Fibroblast for Correction of Nasolabial Folds
NCT ID: NCT03140319
Last Updated: 2020-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2020-12-10
2021-12-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Fibroblast
Injection of Fibroblast
Fibroblast
Transplantation of 20 million cell by three injection
Placebo
the patient receive placebo injection
Placebo
Injection of Placebo
Interventions
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Fibroblast
Transplantation of 20 million cell by three injection
Placebo
Injection of Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age \> 18 years.
* Able and willing to give informed consent
Exclusion Criteria
* The subject has received a soft tissue augmentation to the area to be treated within the last 6 months.
* Subject is unwilling to forgo any cosmetic augmentation procedures for the duration of the study.
* The subject has received autologous fat transfer in the last 6 months.
* Subject is suffering from facial Kaposi's sarcoma.
* The subject has active skin diseases or inflammation on or near the area of injection
* positive HIV, hepatitis B virus (HBV), hepatitis C virus (HCV)
18 Years
65 Years
ALL
No
Sponsors
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SCARM Institute, Tabriz, Iran
OTHER_GOV
Responsible Party
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Principal Investigators
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Peyman Keyhanvar, MD, Ph.D
Role: STUDY_DIRECTOR
Deputy for translational medicine of SCARM institute
Mohammad Nouri, Ph.D
Role: STUDY_CHAIR
Head of SCARM institute
Raheleh Farahzadi, Ph.D
Role: PRINCIPAL_INVESTIGATOR
cardiovascular research center, Tabriz University of Medical Sciences, Tabriz, Iran
Samira Asghari, MSc
Role: PRINCIPAL_INVESTIGATOR
SCARM institute
Locations
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Stem cell and Regenerative Medicine institute (SCARM)
Tabriz, , Iran
Countries
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Central Contacts
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Facility Contacts
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Peyman Keyhanvar, Ph.D
Role: primary
References
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Weiss RA, Weiss MA, Beasley KL, Munavalli G. Autologous cultured fibroblast injection for facial contour deformities: a prospective, placebo-controlled, Phase III clinical trial. Dermatol Surg. 2007 Mar;33(3):263-8. doi: 10.1111/j.1524-4725.2007.33060.x.
Munavalli GS, Smith S, Maslowski JM, Weiss RA. Successful treatment of depressed, distensible acne scars using autologous fibroblasts: a multi-site, prospective, double blind, placebo-controlled clinical trial. Dermatol Surg. 2013 Aug;39(8):1226-36. doi: 10.1111/dsu.12204. Epub 2013 Apr 8.
Purdue GF, Hunt JL, Still JM Jr, Law EJ, Herndon DN, Goldfarb IW, Schiller WR, Hansbrough JF, Hickerson WL, Himel HN, Kealey GP, Twomey J, Missavage AE, Solem LD, Davis M, Totoritis M, Gentzkow GD. A multicenter clinical trial of a biosynthetic skin replacement, Dermagraft-TC, compared with cryopreserved human cadaver skin for temporary coverage of excised burn wounds. J Burn Care Rehabil. 1997 Jan-Feb;18(1 Pt 1):52-7. doi: 10.1097/00004630-199701000-00009.
Rigotti G, Charles-de-Sa L, Gontijo-de-Amorim NF, Takiya CM, Amable PR, Borojevic R, Benati D, Bernardi P, Sbarbati A. Expanded Stem Cells, Stromal-Vascular Fraction, and Platelet-Rich Plasma Enriched Fat: Comparing Results of Different Facial Rejuvenation Approaches in a Clinical Trial. Aesthet Surg J. 2016 Mar;36(3):261-70. doi: 10.1093/asj/sjv231.
Other Identifiers
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SCARM-Skin-001
Identifier Type: -
Identifier Source: org_study_id