Azfibrocel-T Reviewed by FDA for Wrinkle Reduction

Today’s innovative treatments for wrinkle reduction include laser skin resurfacing treatments, facelift surgery and dermal fillers such as Restylane and Botox. However, cell therapy may be another option for men and women in the United States in the near future.

Fibrocell Sicence, Incorporated, a biotechnology company focused on developing regenerative fibroblast cells for aesthetic, medical and scientific application has announced that the U.S. Food and Drug Administration’s Cellular, Tissue and Gene Therapies Advisory Committee is reviewing azfibrocel-T, an autulogous cell therapy for the treatment of nasolabial fold wrinkles in adults.

The FDA is currently evaluating the treatment under the brand name, Laviv ™. The treatment works by using the patient’s own natural fibroblasts. The fibroblasts are extracted, multiplied and then re-injected into the skin as a personalized treatment, allowing for the formation of new cells and stronger connective tissue fibers. Over time, this results in a significant reduction of wrinkles and fine lines, and creates a healthier, more rejuvenated appearance. Fibrocell Science, Incorporated is planning to continue studes for additional aesthetic and therapeutic sues.

Fibrocell Sicence, Incorporated is the result of the reorganization of Isalogen, Incorporated, a company emerging from bankruptcy. Azfibrocel-T was the sole topic of discussion at the Cellular, Tissue and Gene Therapies Advisory Committee Meeting on October 9, 2009 in Maryland. In may 2009, the FDA accepted azfibrocel-T for the treatment of moderate to severe nasolabial fold wrinkles for full review. The target date for an FDA response under the Prescription Drug User Fee Act is January 4, 2010.

If Laviv ™ becomes available in 2010, the treatment will be joining the ranks of fat transfer procedures, laser skin resurfacing and other skin rejuvenation treatments. Laviv ™ would be made available at many plastic surgery centers and aesthetic centers around the United States.