Is Isolagen FDA Approved Yet?

Is it being used for mouth wrinkles/crevices? Does it require a medical expert or only a technician? What is the cost and time-line expected to see results? Is it available in the Phoenix, Az area?

Doctor Answers 1

No.Data has been submitted to the FDA

Isolagen has not been approved in the United States.

A bit of background. In Isolagen a small biopsy is taken behind the patient's ear. The specimen is then harvested for fibroblasts, the cells that produce collagen and elastin. Through the Isolagen process these cells are reproduced numerous times. The fibroblasts are sent back to the physician and injected back into the desired area of the recipient.

It does take awhile to see results as the fibroblasts have to start laying down collagen and elastin. Results in some people can occur quite early, in two months or so. Isolagen, naturally fills in the crevices and wrinkles and should last many months if not years.

The first study submitted to the FDA was an acne trial. While the results were good and the material was safe, the FDA requested that a study which could be better quantified be designed. The company did this and performed the second study, this time using the naso-labila folds which are much easier to grade and evaluate. March of this year the results of this study was submitted for FDA approval.

Isoalgen has subsequently completed a second acne study which, as was the case for the naso-labial fold study, was quite successful.

When/if Isolagen is approved, it will be approved for naso-labial folds and not mouth crevices.

I have no idea of the cost. I imagine it will be pricey since it is very labor intensive and takes skilled scientists to grow the fibroblasts.

Isolagen has been available in Europe, although the company closed down a plant to concentrate in the US effort.

The company does not want this to be a spa type procedure so I am quite sure only specially trained physicians, probably core cosmetic physicians, ie.. dermatololgists and plastic surgeons will be doing the procedure.

The injections are done somewhat differently than other filler injections in that one injects very high up into the dermis.

If you have more questions, please e mail me.

Virginia Beach Dermatologist
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