NCT01115634

Autologous Fibroblast Transplantation in Facial Deformities

Autologous Transplantation of Cultured Fibroblast for Facial Contour Deformities

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Royan Institute · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Nasolabial Folds
• Glabellar Crease
• Deep Wrinkles of the Forehead
• Acne Scars

Interventions

Type	Name	Description
BIOLOGICAL	Fibroblast	20 million cell in three injection
BIOLOGICAL	fibroblast and gel	20 million cell in three injection plus filler

Timeline

• Start date: 2008-09-01
• Primary completion: 2015-09-01
• Completion: 2015-11-01
• First posted: 2010-05-04
• Last updated: 2016-07-21

Locations

1 site across 1 country: Iran