Transplantation of Fibroblast for Correction of Nasolabial Folds

Autologous Transplantation of Cultured Fibroblast for Correction of Nasolabial Folds

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03140319

Enrollment

Registered

2017-05-04

Start date

2020-12-10

Completion date

2021-12-26

Last updated

2020-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasolabial Folds, Skin Aging

Keywords

Fibroblast, Cell transplantation

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%

Interventions

BIOLOGICALFibroblast

Transplantation of 20 million cell by three injection

BIOLOGICALPlacebo

Injection of Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Correction of Nasolabial	6 months after transplantation	Evaluate the correction of skin changes after transplantation of autologous fibroblasts by medical examination

Countries

Iran

Contacts

Primary ContactPeyman Keyhanvar, MD, Ph.D

drkeyhanvar@gmail.com0914 114 6863

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026