Autologous Transplantation of Cultured Fibroblast for Correction of Nasolabial Folds
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Nasolabial Folds
- Sponsor
- SCARM Institute, Tabriz, Iran
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Correction of Nasolabial
- Last Updated
- 5 years ago
Overview
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%
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Correction of Nasolabial
Time Frame: 6 months after transplantation
Evaluate the correction of skin changes after transplantation of autologous fibroblasts by medical examination