FDA Approves laViv (azficel-T);Fibrocell Science

For the improvement of nasolabial fold wrinkles in adults by Fibrocell Science; Approved June 2011

General Information

LaViv (azficel-T) is an autologous cellular product. Collagen-producing fibroblast cells are harvested from the skin behind the ear. The fibroblasts from this tissue sample are cultured and allowed to multiply, so they can be injected to treat appropriate dermal targets. The exact mechanism of action is unknown.

laViv is specifically indicated for improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults.

laViv is for autologous intradermal injection only. The recommended treatment regimen is three treatment sessions, administering up to 2 milliliters (2 vials) of laViv per session, at three to six week intervals.

Side Effects

Adverse events associated with the use of laViv may include, but are not limited to, the following:

• injection-site redness
• bruising
• swelling
• pain
• hemorrhage
• edema
• nodules
• papules
• irritation
• dermatitis
• pruritus

Mechanism of Action

LaViv (azficel-T) is an autologous cellular product. Collagen-producing fibroblast cells are harvested from the skin behind the ear. The fibroblasts from this tissue sample are cultured and allowed to multiply, so they can be injected to treat appropriate dermal targets. The exact mechanism of action is unknown.