It seems the first step to proving the worth of cell therapy has just been made. Late last night, the FDA approved the cell therapy treatment laViv, which uses the patient's own skin cells to improve the appearance of moderate to severe nasolabial fold wrinkles.
The treatment laViv, created by Fibrocell Science, uses the patients' own cells to create an injectable that can be placed into the nasolabial folds or smile lines. Treatment begins with the extraction of a small amount of fibroblasts, a specific skin cell which in normal skin, is responsible for producing collagen. This fibroblast-rich sample is then multiplied at the company's lab to create laViv, which is then shipped back to the physician to be injected into the wrinkles. The process of creating laViv may take up to 22 weeks from extraction.
The concept of banking tissue is not new, with patients now banking their fat from liposuction with hopes that stem cells are indeed capable of all the wonderful things being promised. These patients are banking on future scientific proof and the fat may be banked indefinitely. However, cell banking for laViv is only for a short period of time while fibroblast cells are being multiplied before they are shipped back to the physician and patient for use.
Similar to the dermal filler Sculptra, an injectable that works by stimulating collagen growth, laViv addresses wrinkles by promoting collagen - one the key components to supple youthful skin. Unlike Sculptra which is synthetic, laViv is created from the patient's own fibroblast cells, which may make it a more natural option, particularly for patients who are allergic or unable to use synthetic facial fillers.
Common side effects, which occurred in two-thirds of the 421 FDA case studies, were mild to moderate redness, swelling, bruising, pain and hemorrhage in the injection site. While it is uncertain how much laViv will cost, a Fibrocell spokeswoman did say it would cost approximately $1,000-$2,000 to create the personalized dermal filler and then between $300-$500 for each of the treatments. The FDA study featured 3 separate treatment sessions per patient to determine the efficacy of laViv. At the time of FDA approval, laViv has proven effective for up to 6 months after the final third treatment.