Autologous Fibroblast Transplantation in Facial Deformities

Phase 2

Completed

• Conditions: Glabellar Crease; Nasolabial Folds; Acne Scars; Deep Wrinkles of the Forehead
• Interventions: Biological: Fibroblast; Biological: fibroblast and gel

• Registration Number: NCT01115634
• Lead Sponsor: Royan Institute

Brief Summary

Beautiful skin requires maintenance of proper care. Skin exercise, protections from direct sunlight or harsh wind, and maintaining a healthy diet are some of the ways of having a good and radiant skin. However despite all the care taken passage of time will bring about conditions that will automatically lead to skin aging, which may require certain therapeutic, care. Fibroblasts are cells that synthesize the extracellular matrix and collagen and play a critical role in wound healing and maintenance of healthy skin. Loosing of fibroblast cell is the main problem in aging and wrinkles and non-healed skin wounds. Therefore proliferation of skin fibroblast along with differentiation of stem cells in the skin tissue is the best method for healing.

Detailed Description

Autologous cultured fibroblast is derived from in vitro expansion of fibroblasts harvested from the patient's normal skin. Biopsies from behind a patient's ear are the source of fibroblasts, which are isolated, expanded through cell culture, and used for the correction of facial contour deformities such as nasolabial folds, glabellar crease, deep wrinkles of the forehead, and acne scars. Prior to final packaging, cell viability is assessed to be at least 85%.

Each single use container of autologous cultured fibroblasts has approximately 20 million cells aseptically processed and suspended in 1 mL of sterile, buffered Dulbecco's Modified Eagles Medium (DMEM). Both the biopsy transport media and the cell culture media contain gentamicin. Residual quantities of gentamicin up to 5 µg/mL may be present in the Cell product

Study Timeline

• Study Start: 2008-09
• Status Verified: 2010-05
• Study First Submitted: 2010-05-01
• Study First Submitted QC: 2010-05-01
• Study First Posted: 2010-05-04
• Primary Completion: 2015-09
• Study Completion: 2015-11
• Last Update Submitted: 2016-07-20
• Last Update Posted: 2016-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 collagen fillers
• 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, HBV, HCV

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Fibroblast	fibroblast and gel	Injection of autologous cultured fibroblast
Fibroblast	Fibroblast	Injection of autologous cultured fibroblast

Primary Outcome Measures

Name	Time	Method
2-point shift in at least one treated area using a standardized 7-point photoguide	6 months

Trial Locations

Locations (1)

Royan Institute; 🇮🇷 Tehran, Iran, Islamic Republic of