Transplantation of Fibroblast for Correction of Nasolabial Folds

Phase 1

• Conditions: Skin Aging; Nasolabial Folds
• Interventions: Biological: Fibroblast; Biological: Placebo

• Registration Number: NCT03140319
• Lead Sponsor: SCARM Institute, Tabriz, Iran

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%

Study Timeline

• Study First Submitted: 2017-05-02
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-04
• Status Verified: 2020-07
• Last Update Submitted: 2020-10-24
• Last Update Posted: 2020-10-27
• Study Start: 2020-12-10
• Primary Completion: 2021-11-15
• Study Completion: 2021-12-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fibroblast	Fibroblast	Injection of Fibroblast
Placebo	Placebo	the patient receive placebo injection

Primary Outcome Measures

Name	Time	Method
Correction of Nasolabial	6 months after transplantation	Evaluate the correction of skin changes after transplantation of autologous fibroblasts by medical examination

Trial Locations

Locations (1)

Stem cell and Regenerative Medicine institute (SCARM); 🇮🇷 Tabriz, Iran, Islamic Republic of