LAVIV (azficel-T) is the first and only FDA-approved therapy that uses your own collagen-producing cells (fibroblasts) to improve the look of your smile lines and reduce wrinkles – for results that are totally you.
If you live in the Dallas / Fort Worth area, and are interested in reducing the appearance of wrinkles and improve your smile, contact us today for a complimentary consultation. We have offices conveniently located in Uptown Dallas and Plano.
What is LAVIV?
LAVIV is the first and only FDA-approved autologous cellular therapy to improve the appearance of moderate to severe nasolabial fold wrinkles.
What is the indication for LAVIV?
LAVIV is an autologous cellular product indicated for the improvement of the appearance of moderate to severe nasolabial fold wrinkles in adults. The safety and efficacy of LAVIV for areas other than the nasolabial folds have not been established. The efficacy of LAVIV beyond six months has not been established.
How does LAVIV work?
LAVIV is an autologous cellular product containing fibroblast cells, which are grown from a patient’s post-auricular skin biopsy tissue. These skin samples are sent to a Fibrocell Science lab where they are aseptically expanded until sufficient cells for treatment are obtained. Cells are then cryopreserved. Once patient administration has been scheduled, these cells are thawed, washed, and shipped to your clinic.
LAVIV-which is made up of at least 98% pure fibroblasts-places a patient’s own living cells into the treatment area to biologically improve the appearance of nasolabial fold wrinkles. The exact mechanism of action of injected autologous fibroblasts is unknown.
What makes LAVIV unique?
Each patient’s LAVIV treatment is unique because it is made from that patient’s own skin cells. In order to be approved by the FDA, LAVIV was held to high efficacy standards. In clinical trials, LAVIV demonstrated a statistically significant improvement as measured by both a physician and patient assessment scale, where improvement was defined as a 2-point improvement on the scales. These trials were designed to be vehicle-controlled and demonstrate superiority to vehicle. Each dose of LAVIV is also held to strict testing standards to ensure product performance and safety.
Who is an appropriate patient for LAVIV?
LAVIV may be an appropriate treatment for adults who desire an improved appearance of nasolabial fold wrinkles, an autologous cellular product, and a treatment regimen that delivers gradual results.
What kind of patients should not use LAVIV?
How long do results last?
In 2 clinical studies, the majority of patients treated with LAVIV and their physicians reported a noticeable improvement in the appearance of nasolabial fold wrinkles at 6 months. Efficacy beyond 6 months was not evaluated.
What are the most common side effects associated with LAVIV?
The most common adverse reactions occurring in ≥1% of subjects in clinical trials were injection-site redness, bruising, swelling, pain, hemorrhage, edema, nodules, papules, irritation, dermatitis, and pruritus. More than 80% of all adverse reactions were local and required no treatment. Eighty-six percent of all injection-site adverse reactions resolved within one week.