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June 23, 2011

FDA Approves Autologous Filler

There has been a lot of hype about stem-cell therapy for facelifting.  As a Board Certified Plastic Surgeon, I find those claims comical.  Please don't fall victim to clever advertising.

However, the biologists have tremendously improved our understanding of cellular biology, and it looks like some of that basic science will legitimately hit the plastic surgery world soon.  On June 21, 2011, the U.S. Food and Drug Administration (FDA) approved the first autologous cell therapy for purely aesthetic purposes.

The product, azficel-T (laVív), is from Fibrocell Science, Inc.  According to company records, azficel-T involves a patented technology whereby fibroblasts are extracted from behind the patient's ear (via a small biopsy); sent to the Fibrocell Science laboratory; multiplied for about 3 month;s and then frozen until needed.

Over a series of 3 treatment sessions, typically 3 to 6 weeks apart, those cells are then injected back into the patient's face.  The goal is to fill in creases--such as at the nasolabial folds, which would then reduce the appearance of smile lines.

In effect, azficel-T will provide a true biological solution for deep folds and wrinkles.  The results should be gradual and natural-looking.

My opinion is that this technology is certainly interesting, and I will definitely invest the time and effort to become proficient with azficel-T.  However, I suspect that the product will not be revolutionary.  I bet that the results will not be much better than the current crop of chemical fillers (such as Juvederm and Restylane) or the current biological/stimulatory fillers (such as Sculptra).  Almost certainly, azficel-T will, however, appeal to a niche of patients who demand "natural" and who want to use their own cells (rather than a lab-produced product).

The big negative will be that patients will have to have a biopsy, wait 3 months before they get their injections, and then undergo a series of treatments (rather than just one session).  A long, drawn-out process will not be appealing in our "fast-food culture."

Also, azficel-T will likely be pricey.  No word yet as to how it will compare with Juvederm or Restylane for ~$500-500, but I suspect that azficel-T will hurt in the wallet.

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Comments

Cosmetic Surgeon

Thanks for the info. Quick question: what the advantages and disadvantages of autologous over other dermal fillers?

filler

That is some news. FDA should be thanked

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