Transplantation of Fibroblast for Correction of Nasolabial Folds

SCARM Institute, Tabriz, Iran50 enrolled

Overview

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%

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Nasolabial Folds Skin Aging

Interventions

FibroblastBIOLOGICAL

Transplantation of 20 million cell by three injection

PlaceboBIOLOGICAL

Injection of Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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)

Locations (1)

Stem cell and Regenerative Medicine institute (SCARM)

Tabriz, Iran

Outcomes

Primary Outcomes

Correction of Nasolabial

Evaluate the correction of skin changes after transplantation of autologous fibroblasts by medical examination

Time frame: 6 months after transplantation

Central Contacts

Peyman Keyhanvar, MD, Ph.D

CONTACT

0914 114 6863 drkeyhanvar@gmail.com

Data from ClinicalTrials.gov

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