Safety and Efficacy Study of Autologous Fibroblasts in the Treatment of Severe Facial Acne Scarring

Inclusion criteria

• Male or female, between 18 years and 65 years of age.
• Investigator assessment of the acne scarring on each cheek of moderate to severe.
• A history of acne scarring for more than 3 years.
• Subject assesses the appearance of both sides of their facial acne scars as dissatisfied or very dissatisfied with appearance.

Exclusion criteria

• Significant active acne.
• Use of oral antibiotic or retinoid active acne therapy within one year of enrollment.
• Presence of hypertrophic scars on the cheeks.
• More than 20% of treatment area comprised of ice pick scars or sinus tracts
• Treatment area per cheek is less than 9 cm x cm
• Unilateral or unbalanced acne scar distribution.
• Physical attributes which prevent the assessment or treatment of the acne scars.
• Treatment with an investigational product or procedure within 30 days prior to study enrollment or plans to participate in another clinical trial during the course of this study.
• Previous treatment with Isolagen TherapyTM.
• Use of Isotretinoin within one year of enrollment into study.
• Use of permanent or semi-permanent dermal fillers in the treatment areas within defined time frames.
• Disorders or drugs that increase bleeding or clotting.
• Pregnant or lactating women or women trying to become pregnant during the study.
• Excessive exposure to sun.
• Smoking more than ½ pack of cigarettes per day.