EXTON, Pa., June 22, 2011 – Fibrocell Science, Inc. (OTCBB:FCSC.OB), a cell therapy company focused on the development of autologous (personalized) cell therapies for aesthetic, medical and scientific applications, announced today that the U.S. Food and Drug Administration (FDA) approved the Company’s Biologics License Application for its lead product, laVív® (azficel-T) late last night. laVív is the first and only personalized aesthetic cell therapy approved by the FDA for the improvement of the appearance of moderate to severe nasolabial fold wrinkles (smile lines) in adults. In clinical trials, laVív was well tolerated with the majority of adverse events being injection-site reactions that were of mild to moderate intensity and resolved within one week.
The cells are the patient's own, removed and grown outside the body for reinjection.
The patented technology behind laVív is an advanced process that extracts and multiplies a specific kind of a person’s own skin cells (fibroblasts) to create LAVIV, which is then injected into the patient to improve the appearance of smile lines. In normal skin, fibroblasts are responsible for producing collagen.
While this therapy probably works an even better one would include added steps to select fibroblast cells which are least damaged from aging, more steps to rejuvenate those cells (e.g. make longer telomeres and reduce the DNA methylation that accumulates with age. Techniques to make cells younger and less damaged will lower the risks of cell therapies while at the same time make the therapies more effective and longer lasting.
Since the cells get injected a few times over a few months and then they divide and make collagen it takes months for the full benefit.
“The concept of using a patient’s own collagen-making cells is a revolutionary way to help treat nasolabial fold wrinkles and help restore a fresh appearance,” said Dr. Robert A. Weiss, Clinical Associate Professor, Johns Hopkins School of Medicine and Director, Maryland Laser Skin & Vein Institute, and an investigator for the LAVIV clinical trials. “Since this is a biological process that works over time, LAVIV is able to provide gradual and natural-looking results.”
We could have more stem cell therapies with existing biotechnology. How about anterior cruciate ligament repair with stem cells? Stem cell therapy to fix race horse joints is already done because animal treatments are much less regulated than human treatments. I never realized before that I had an important reason to like horse racing: the revenue from horse racing helps fund rejuvenation therapies that will also some day get used to treat humans. The same is true for pet stem cell therapies.
(thanks Lou Pagnucco for the latter 2 links)
|Share |||Randall Parker, 2011 June 22 11:54 PM Aging Appearances|