Transplantation of Fibroblast for Correction of Nasolabial Folds

SCARM Institute, Tabriz, Iran

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Nasolabial Folds; Skin Aging

Treatments: Biological: Fibroblast; Biological: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03140319

SCARM-Skin-001

Details and patient eligibility

About

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

Full 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%

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Fibroblast

Experimental group

Description:

Injection of Fibroblast

Treatment:

Biological: Fibroblast

Placebo

Placebo Comparator group

Description:

the patient receive placebo injection

Treatment:

Biological: Placebo