(+) Laviv (azficel-T) pivotal trial data published in peer-reviewed journal, Dermatologic Surgery (Businesswire) - Apr 17, 2012 - P3, N=203, N=218; IT-R-005; IT-R-006; Fibrocell Science announced that pivotal clinical trial data demonstrating the effectiveness of Laviv for the improvement of the appearance of moderate-to-severe nasolabial fold wrinkles ("smile lines") is published online by Dermatologic Surgery; It will also be published in an upcoming print issue; The publication in Dermatologic Surgery includes the combined results of two identically-designed, Phase III studies that showed efficacy results for Laviv; Laviv showed a good safety profile in the studies; the most common adverse events were mild to moderate injection site reactions
P3 pooled data • Fibrosis
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Fibrocell Science, Inc. (OTCBB:FCSC.OB) announced that pivotal clinical trial data demonstrating the effectiveness of LAVIV™ (azficel-T) for the improvement of the appearance of moderate-to-severe nasolabial fold wrinkles (“smile lines”) is published online by Dermatologic Surgery, the official, peer-reviewed publication of the American Society for Dermatologic Surgery. It will also be published in an upcoming print issue. LAVIV is a breakthrough aesthetic treatment made from millions of a person’s own living, cultured, collagen-producing fibroblast cells and then injected into smile line wrinkles. This data supported the FDA approval of LAVIV and the publication is another significant development in the company's stated goal of being the leader in fibroblast evidence-based science.
The publication in Dermatologic Surgery includes the combined results of two identically-designed, Phase III, multi-center, randomized, double-blind, placebo-controlled, studies of 421 patients that showed statistically significant efficacy results for LAVIV. The criteria for a positive response included a 2-point improvement on the Subject Wrinkle Assessment Scale and a 2-point improvement on the Evaluator Wrinkle Assessment Scale for both nasolabial fold wrinkles. LAVIV showed a good safety profile in the studies; the most common adverse events were mild to moderate injection site reactions. See Below for Important Safety Information About LAVIV (azficel-T).
“This large, comprehensive study included strict criteria for demonstrating improvement in the appearance of moderate to severe smile line wrinkles,” said Dr. Stacy R. Smith, Associate Clinical Professor in the Division of Dermatology at the University of California, San Diego and lead author of the publication. “LAVIV is the first personalized cell therapy for aesthetic improvement to show a statistically significant benefit in large, controlled trials,” he added.
The patented technology behind LAVIV is an advanced process that extracts a person’s fibroblast cells from a small skin sample and multiplies them in the Fibrocell Science lab. In normal skin, fibroblasts are responsible for producing collagen. LAVIV is the resulting formulation of a person’s own living, cultured fibroblast cells, which is then injected into smile line wrinkles. Each person’s formulation of LAVIV is unique because it is made from their own fibroblast cells.
“We are pleased that the results of our pivotal clinical trials are now published in a prestigious, peer-reviewed journal such as Dermatologic Surgery,” said David Pernock, Fibrocell Science Chairman and CEO. “Fibrocell Science takes pride in how we design and implement our clinical investigations, proving to the scientific community that our findings are sound.”
Related
A multicenter, double-blind, placebo-controlled trialof autologous fibroblast therapy (azficel-T) for the treatment of nasolabialfold wrinkles
http://onlinelibrary.wiley.com/doi/10.1111/j.1524-4725.2012.02349.x/abstract
Mar 12, 2012
Background
Changes associated with aging are partly due to loss of collagen and elastin. Treatment with autologous fibroblasts grown in culture (azficel-T) can help correct the appearance of aging by replacing lost dermal constituents.
Objective
To demonstrate the safety and effectiveness of autologous fibroblasts in the treatment of nasolabial fold (NLF) wrinkles.
Methods and Materials
Adults with moderate to very severe NLF wrinkles were randomized to receive three treatments with autologous fibroblasts or placebo at 5-week intervals. Blinded evaluators and subjects assessed efficacy using a validated wrinkle assessment scale.
Results
Three hundred seventy-two subjects were enrolled and underwent treatment. Seventy-eight percent of subjects treated with azficel-T and 48% of subjects treated with placebo achieved at least a 1-point improvement on the subject assessment at 6 months (p
Conclusion
Azficel-T is safe and effective for the treatment of NLF wrinkles. The availability of autologous cell therapy marks the beginning of a new phase in aesthetic therapy.
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