LAVIV: Is it Worth the Risk?

Do you have–horror of horrors–smile lines? Well, now there is hope on the horizon. The FDA has just approved LAVIV, the first “autologous cellular product” (cells that come from you) for treatment of “severe nasolabial fold wrinkles” (smile lines). Apparently, the healthcare professional takes some of your own skin cells (fibroblasts) from behind your ear, Fibrocell Science Inc. grows more in the lab, sends them to your healthcare provider, and he or she injects them into your smile lines. Since the cells are from you, and fibroblasts make collagen, surely that is a great idea! Right?

Well, let’s think about that. First the healthcare professional removes some of your fibroblasts. That’s okay. You shed lots of them every day anyway. Next, he or she sends them to a lab where they are encouraged to multiply. Here the problems begin. Growing cells outside of the body requires keeping them in a highly nutritious fluid or medium, which is very attractive to infectious agents. Thus, antibiotics are routinely added to the culture medium. And, since we do not actually know everything cells require for optimum growth, the standard practice is to also add a bit of cow’s blood extract (bovine serum albumin). Your cells are grown in this concoction of medium, antibiotics and albumin. Therefore, those who are allergic to gentamicin, amphotericin, or cow-related products should not use LAVIV.

Another issue of concern is that, while in the lab, yours are not the only fibroblasts being handled by the technician or in the incubator. Since cells in culture have to be fed regularly, cross contamination can occur. And, as the FDA warns, there is no testing for adventitious viruses nor are sterility tests conducted on cells arriving at the clinic. A rare complication of treatment with LAVIV can be Herpes infection. After treatment you won’t have wrinkles, but you may have cold sores.

Next, because LAVIV needs to be administered in three doses and transported back to the healthcare provider, the cells are frozen in a solution containing dimethyl sulfoxide (DMSO), a type of antifreeze. Therefore, those allergic to DMSO should not use LAVIV. Interestingly, when using DMSO, the material safety data sheet advises laboratory workers to wear thick gloves and safety goggles. Nothing is said about whether DMSO should be injected into people.

Finally, the cells are defrosted, thoroughly rinsed, and injected into the patient’s smile lines. The claim is that the beneficial effect on appearance lasts for up to six months and that few people experience negative side effects, such as vasculitis, allergic reaction, hemorrhage, or scarring.  What they do not mention is that those who work with cells know that they should NEVER work with their own because growing cells in tissue culture can cause them to become transformed (cancerous). Perhaps this is why there is already a report of a patient developing basal cell cancer after treatment with LAVIV. Currently, this occurs in less than 1% of those who are treated, but it is important to be aware that the after effects of treatment with LAVIV have not been studied for longer than a year. Therefore, only time will tell if the risk is actually higher than this.

So, how good does this treatment make you look? Is it worth the money and the risk? AITSE could only find one before and after photo. Looks like the difference is only visible if a person looks very, very sad. Since smiling and laughter have proven health benefits, laugh lines seem to be the better option.