U.S. medicines regulatory agency (Food and Drug Administration / FDA) approved the launch of the first customized cell therapy against wrinkles, announced Wednesday Fibrocell Science, the company that developed this therapy, informs AFP.
FDA representatives have authorized this treatment, called Viv (azficel-T) on Tuesday, says the company Fibrocell Science in a statement.
Viv is the first and also the only treatment approved by FDA aesthetic custom cell to reduce wrinkles in adults, particularly pronounced when a person smiles.
This treatment is the removal of skin cells, fibroblasts, and their cultivation in the laboratory so that they multiply, and then re-injected into wrinkles as to mitigate them.
In normal skin, fibroblasts produce collagen, the fibrous protein that provides a specific tissue mechanical strength to the tensile force.
In clinical trials organized, well-tolerated therapy patients Viv. Most side effects observed were the weak skin reactions, which disappeared in less than a week.
FDA authorized the marketing of the treatment, after reviewing the results of two Phase 3 clinical trials, conducted on a sample of 421 patients.
"Using patient cells that produce collagen, is a revolutionary tool in the treatment of nasolabial wrinkles, restoring fresh face," said Robert Weiss, associate professor at the faculty of medicine at Johns Hopkins University in the U.S. state of Maryland and Maryland Institute Director Laser Skin and Vein.
Robert Weiss is the researcher who led the clinical trials in which therapy was used Viv.
New wrinkle treatment The U.S. agency that regulates drugs and food approved the sale of the first aesthetic treatment cell for facial wrinkles, announced Wednesday Fibrocell Science, which developed this therapy. The treatment involves removing skin cells and cultured to multiply, before re-injected into wrinkles, and so attenuate them. In normal skin, cells produce collagen, fibrous proteins that give the tissues a mechanical resistance to stretching. AFP
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