The number of available injectable filler options has grown exponentially since the first non-collagen based products became available in 2002. Since then more than a dozen new variations of fillers has appeared, most of which are derivatives of hyaluron-based materials. All of these injectable materials have a limited duration of effectiveness because they are broken down and absorbed. The search for longer-lasting fillers is ongoing but has remained elusive to date.
There is great appeal in using filler materials extracted from the patient as it is both natural and may last much longer or even be permanent. Such has been the widespread use of liposuction-harvest fat but that is not as convenient as a more off-the-shelf product. In that vein, a company called Fibrocell Science has just received FDA approval for an injectible wrinkle treatment thatuses a patient’s own cells.
According to the company and its product name, LaVív, it is an aesthetic cell therapy for improving the appearance of moderate-to-severe nasolabial folds in adults. The treatment uses a patient’s own fibroblastswhich are extracted from a punch biopsy behind the ear. It is then sent to Fibrocell’s laboratory where the patient’s fibroblasts are grown and eventually returned to the physician for injection into the patient. The theory is that these transplanted fibroblasts will produce new collagen which will then fill and plump out the nasolabial fold. The entire process from harvest to treatment time is about 50 days. The fibroblast cultures are stored at the company so repeat injection material can be obtained for future treatments.
The clinical study submitted to the FDA for this autologous injection therapy was based on treatment results from human nasolabial folds being injected in three sessions spaced about six weeks apart. The results showed that a significantly greater number of patients had reduced nasolabial folds when injected with laVív than with a placebo. The patients were evaluated out to six months after the treatments.
While the FDA approval for this technology is recent, it is a older technique that was initially introduced over a decade ago. At that time, it was offered as a physician-ordered treatment that did not have FDA-approved status. I did several patients at that time and was using it in the treatment of depressed facial scars, specifically acne scars. It was my understanding that the company eventually decided to seek FDA approval for fear that growing and storing human cells would eventually come under the scrutiny of the FDA. This is now the fruit of a long effort at going through the FDA submission process.
In seeking FDA approval, it was logical to conduct the study for this autologous injection in the treatment of nasolabial folds. This is because every synthetic injectable filler that is commercially available is based on the use of nasolabial folds. This represents the easiest path for a study submitted to the FDA to gain approval. It can only be marketed as such but physicians no doubt will apply it to many other facial areas and aesthetic needs as well.
Does these fibroblast injections work? Do they grow, produce collagen, and last permanently? Is it better long-term that investing in temporary synthetic injectable fillers? These are the questions that widespread clinical use will eventually answer.
Dr. Barry Eppley
Indianapolis Indiana