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The study evaluated the safety and efficacy of the Autologous cultured fibroblast for correction of Nasolabial folds and inhibition of skin aging
Autologous cultured fibroblast which is obtain from the patient's normal skin is harvested and expanded in an in vitro. Biopsies samples are obtained from the behind of the patient's ear as a source of fibroblasts, then fibroblast cells isolated and expanded through cell culture, and used for the correction of Nasolabial folds, deep wrinkles of the forehead. Prior to final packaging, cell viability is assessed to be at least 85%
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fibroblast | Experimental | Injection of Fibroblast |
|
| Placebo | Placebo Comparator | the patient receive placebo injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fibroblast | Biological | Transplantation of 20 million cell by three injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Correction of Nasolabial | Evaluate the correction of skin changes after transplantation of autologous fibroblasts by medical examination | 6 months after transplantation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peyman Keyhanvar, MD, Ph.D | Contact | 0914 114 6863 | drkeyhanvar@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Peyman Keyhanvar, MD, Ph.D | Deputy for translational medicine of SCARM institute | Study Director |
| Mohammad Nouri, Ph.D | Head of SCARM institute | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stem cell and Regenerative Medicine institute (SCARM) | Tabriz | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17338681 | Result | 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. | |
| 23566237 | Result | 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. |
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| Placebo | Biological | Injection of Placebo |
|
| Raheleh Farahzadi, Ph.D |
| cardiovascular research center, Tabriz University of Medical Sciences, Tabriz, Iran |
| Principal Investigator |
| Samira Asghari, MSc | SCARM institute | Principal Investigator |
| 9063788 | Result | 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. |
| 26879294 | Result | 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. |