Clinical trial NCT03140319: Transplantation of Fibroblast for Correction of Nasolabial Folds
Official title: Autologous Transplantation of Cultured Fibroblast for Correction of Nasolabial Folds
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Nasolabial Folds
Skin Aging
Keywords: Fibroblast
Cell transplantation
Lead sponsor: SCARM Institute, Tabriz, Iran
Sponsor class: OTHER_GOV
First posted: 2017-05-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study evaluated the safety and efficacy of the Autologous cultured fibroblast for correction of Nasolabial folds and inhibition of skin aging

Detailed description: 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%

Eligibility criteria: Inclusion Criteria:

* Available and willing to attend all follow-up visits.
* Age \> 18 years.
* Able and willing to give informed consent

Exclusion Criteria:

* Known allergy or sensitivity to any cellular products
* 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)

Primary outcomes:
measure: Correction of Nasolabial
timeFrame: 6 months after transplantation
Secondary outcomes:
Other outcomes:
Locations:
city: Tabriz
country: Iran, Islamic Republic of
facility: Stem cell and Regenerative Medicine institute (SCARM)
Study officials:
affiliation: Deputy for translational medicine of SCARM institute
name: Peyman Keyhanvar, MD, Ph.D
role: STUDY_DIRECTOR
affiliation: Head of SCARM institute
name: Mohammad Nouri, Ph.D
role: STUDY_CHAIR
affiliation: cardiovascular research center, Tabriz University of Medical Sciences, Tabriz, Iran
name: Raheleh Farahzadi, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: SCARM institute
name: Samira Asghari, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.