Meaningful Results: A Noticeable Improvement in the Look of Smile Lines
LAVIV™ (azficel-T) personalized cell therapy has been proven to deliver meaningful and noticeable results. In two rigorous clinical studies in which wrinkles were evaluated by both patients receiving LAVIV™ and their physicians, patients and physicians reported a statistically significant improvement in the appearance of smile lines compared to those who didn’t receive LAVIV™. For results to be counted, a 2-point improvement had to be noted by both the patient and physician. Two-point improvements in this setting are considered clinically meaningful.The photos below illustrate significant improvements as noted by both patient and physician. Learn more about the physician and patient evaluation scales
The photos below illustrate significant improvements as noted by both patient and physician.
Physicians used a 6-point scale while Patients used a 5-point scale (see below) to assess the appearance of smile lines in LAVIV™-treated patients both before administering LAVIV™ and 6 months after the third and final LAVIV™ treatment.
Physician Evaluation Scale
Patient Evaluation Scale
LAVIV™ side effects and safety information
- In clinical trials, more than 80% of all side effects occurred at the injection site and required no treatment. Eighty-six percent of all injection site side effects went away within one week. The most common side effects with LAVIV™ occur at the injection site. These side effects include redness, bruising, swelling, pain, bleeding, lumps, irritation, and itchiness.
- Be sure to tell your health care provider or call the emergency department right away if you have:
- Difficulty breathing, trouble swallowing, rash, hives, or severe redness and swelling, because these may be signs of a serious allergic reaction
- Fever above 100°F or redness, warmth, or pain at the injection or biopsy site lasting for more than 3 days, because these may be signs of a serious infection
- These are not all the possible side effects of LAVIV™. Tell your health care provider about any side effects that concern you. You may report side effects to the FDA at
- When being treated with LAVIV™, tell your health care provider about all the medicines you take, including prescription and nonprescription drugs (eg, aspirin, vitamins, and dietary supplements). Your health care provider will advise you about the use of these medicines during LAVIV™ treatment.
- People who have bleeding disorders or who take blood-thinning medicines may have more bleeding with LAVIV™ treatment. People with immune problems or who take medicines that affect the immune system can get infections or have healing problems with LAVIV™ treatment.
Aftercare instructions for LAVIV™
Once you and your Fibrocell-trained physician have decided that LAVIV™ is right for you, you will be given instructions on how to care for your skin following your treatment sessions. Be sure to ask your Fibrocell-trained, board-certified dermatologist or plastic surgeon or your personal physician for more information.
Creating your LAVIV™
- It takes approximately 3 months to expand your fibroblast cells and conduct a comprehensive quality control check on these fibroblasts before your LAVIV™ is ready to be shipped back to your health care provider or skin care specialist.
- For the treatment of the look of smile lines, LAVIV™ is administered over 3 separate treatment sessions
Next: Creating Your LAVIV™