A friend of mine at a local media outlet was pitched a story about Laviv and asked for my thoughts. So I looked into it for her. We talked about it here once before, but I updated my search to be fair:

Laviv is a fibroblast cell product which is formulated as a tissue filler. The idea is new though. The company takes a sample of skin from behind the ear and use a little cell culture magic and make many new patient “cloned” fibroblasts. Then these are injected into the skin of that same patient in three parts separated by 5 weeks or so. The cool thing is that these are cells that should be identical to some of the cells the patient would have there already. Then again fibroblasts are basic cells to healing, but who is to say what a big pile of them injected below someone’s skin will do?

A key question is what is the long term effect here and that of course is not known. The FDA approval was based on a relatively small study showing better than placebo effects on nasolabial folds six months after a three treatment series. The study group was only 421 patients. There are post study approval requirements from the FDA; another 2700 patients to be followed.

The idea is very high tech and expensive. Another central question is how dangerous might it be (cancer, etc) and how long will the results (if we get any) last? How will Laviv compare to other products on the market which are ten to twenty times cheaper? The FDA pre-approval study did not compare it to anything but a lack of treatment. Not very encouraging.

I wouldn’t be getting too excited, but then new high tech stuff rarely gets me excited without some real proof behind it. We have little of that here.

Best Regards,

John Di Saia MD

Originally posted 2012-04-10 07:30:44.