Autologous Fibroblast Transplantation in Facial Deformities

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

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