Safety and Efficacy Study of Isolagen TherapyTM in the Treatment of Nasolabial Fold Wrinkles

Inclusion criteria

• Subject is at least 18 years of age
• Level of severity of bilateral nasolabial fold wrinkles meeting severity criteria as per protocol
• Level of subject dissatisfaction with both nasolabial fold wrinkles as per protocol
• Ability to comply with the study requirements
• Negative pregnancy test (Females)
• Healthy post-auricular skin for biopsy

Exclusion criteria

• Excessive dermatochalasis of the treatment area
• Inability to lessen the nasolabial fold wrinkles by physically spreading the area apart
• Total area to be treated exceeds 20 cm in length
• Physical attributes which may prevent assessment or treatment as judged by the evaluator
• Use of an investigational product/procedure within 30 days prior to enrollment or plans for use during the study
• Previous treatment with the sponsor's product
• History of active autoimmune disease or organ transplantation
• Diagnosis of cancer, unless successfully treated or in remission (basal cell carcinoma is excluded)
• Active or chronic skin disease
• Known genetic disorders affecting fibroblasts or collagen
• Active systemic infection
• Requires chronic antibiotic or steroidal therapy
• Use of certain commercial products/procedures to the treatment area prior to study enrollment or plans for use during the study
• Use of systemic agents that increase bleeding or clotting, or disorders equated with these effects
• Known allergic reactions to agents used in preparation of treatment
• Excessive exposure to sun without adequate sun protection