Transplantation of Fibroblast for Correction of Nasolabial Folds

Autologous Transplantation of Cultured Fibroblast for Correction of Nasolabial Folds

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

Study Overview

• Status: Unknown
• Conditions: Skin Aging; Nasolabial Folds
• Intervention / Treatment: Biological: Fibroblast; Biological: Placebo

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%

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Peyman Keyhanvar, MD, Ph.D; Phone Number: 0914 114 6863; Email: drkeyhanvar@gmail.com

Study Locations

• Iran, Islamic Republic of
  • Tabriz, Iran, Islamic Republic of
    • Stem Cell And Regenerative Medicine institute (SCARM)
    • Contact: Peyman Keyhanvar, Ph.D
    • Sub-Investigator: Neda Keyhanvar, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Fibroblast; Injection of Fibroblast	Biological: Fibroblast; Transplantation of 20 million cell by three injection; Other Names: Autologous injection of Fibroblast
PLACEBO_COMPARATOR: Placebo; the patient receive placebo injection	Biological: Placebo; Injection of Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: SCARM Institute, Tabriz, Iran
• Investigators: Principal Investigator: Samira Asghari, MSc, SCARM Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 10, 2020
• Primary Completion (ANTICIPATED): November 15, 2021
• Study Completion (ANTICIPATED): December 26, 2021

Study Registration Dates

• First Submitted: May 2, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (ACTUAL): May 4, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 24, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Fibroblast; Cell transplantation
• Other Study ID Numbers: SCARM-Skin-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No