laViv (azfibrocel-T),

FDA Approves Treatment That Uses Patient's Own Cells To Restore Skin Elasticity.

Bloomberg News (6/23, Peterson) reports Fibrocell Science won Food and Drug Administration "approval for an injectible wrinkle treatment that uses a patient's own cells to restore elasticity to the skin." The treatment, called laViv (azfibrocel-T), "will be Fibrocell's initial marketed product and the first wrinkle smoother made from a patient's cells."

        The New York Times (6/22, Pollack) "Prescriptions" blog reported the treatment "involves taking a sample of skin cells called fibroblasts, which make collagen, from behind the person's ear." Next, the "sample is sent to the company's laboratory, where the fibroblasts are multiplied in cell culture, a process that takes 11 to 22 weeks." Finally, "the cells are then sent back to the doctor, who injects them into the smile lines, (or frown lines), which are technically known as nasolabial folds."

        AFP (6/23) reports, "Fibrocell said the FDA approval came after two phase III randomized, double blind trials of 421 patients who received either laViv or a placebo in three treatments about five weeks apart." AFP reports, "In one study, 57 percent of patients on laViv saw an improvement compared to 30 percent who received the placebo treatment, according to a summary of the research published by the New York Times. In the other, 45 percent of patients receiving laViv thought they looked better afterward, compared to 18 percent in the control group." Medscape (6/22, Brooks) also covered the story.

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