Safety and Efficacy Study of Isolagen TherapyTM in Treatment of Facial Wrinkles and Creases

Inclusion Criteria:

• Male or female, at least 18 years of age
• High Investigator wrinkle severity assessment score
• Subject assessment of dissatisfaction of facial appearance
• Provide written informed consent and comply with the study requirements
• Negative pregnancy test at screening visit
• Healthy, non-scarred skin for biopsy

Exclusion Criteria:

• Low Investigator wrinkle severity assessment score
• Subject assessment of satisfaction of facial appearance
• Physical attributes which prevent the assessment or treatment of the facial wrinkles
• Treatment with an investigational product or procedure within 30 days or plans to participate in another clinical trial
• Previous treatment with Isolagen Therapy
• History of active autoimmune disease or organ transplantation
• Diagnosis of cancer, receiving active treatment
• History of pigmentary disorders which can affect the face
• Active or chronic skin disease
• Known genetic disorders affecting fibroblasts or collagen
• Active systemic infection
• Requires chronic antibiotic or steroidal therapy
• Use of certain cosmetic treatments & procedures
• Use of systemic agents that increase bleeding or clotting, or disorders equated with these effects
• Pregnant or lactating women or women trying to become pregnant
• Known allergic reaction to components of study treatment and/or study injection procedure
• Excessive exposure to sun or sunburn in the post-auricular area
• Subject has any disorder that may prevent compliance
• Subject who is part of the study staff, a family member or friend