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.

Clinical Results

FDA Approval
The FDA approval of laViv was based on two identicall multi-center, randomized, double-blind, placebo controlled studies. The trial enrolled 421 subjects 23 to 81 years with moderate to severe bilateral nasolabial fold wrinkles. Each subject underwent three post-auricular skin punch biopsies to obtain skin tissue to generate laViv. Subjects whose biopsy samples met acceptance criteria were randomized to receive either laViv or placebo administered intradermally to nasolabial fold wrinkles on both sides of the face. A total of three separate treatment sessions occurred at intervals of approximately five weeks. For both clinical trials, the co-primary efficacy outcomes were the proportion of subjects with a two-point improvement from baseline in the appearance of the nasolabial fold wrinkles at six months after the third treatment session, assessed independently by subjects and by evaluating physicians. Subjects assessed their nasolabial fold wrinkles on a five-point Subject Wrinkle Assessment scale that ranged from -2 to +2. The evaluating physicians used a six-point Evaluator Wrinkle Severity Assessment scale that ranged from 0 to 5. When subjects assessed themselves, 57% (Study One) and 45% (Study Two) of subjects receiving laViv achieved a 2-point improvement in the appearance of their nasolabial fold wrinkles compared with 30% (Study One) and 18% (Study Two) of subjects receiving placebo control. When assessed by evaluating physicians, 33% (Study One) and 19% (Study Two) of subjects receiving laViv achieved a 2-point improvement in their nasolabial fold wrinkles, compared with 7% of subjects receiving vehicle-control in both trials.

Mechanism of Action