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

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