美国FDA已批应用的干细胞化妆品.pdfVIP

Clinical Review BLA 125348 1. EXECUTIVE SUMMARY 1.1 Brief Overview of Clinical Program Isolagen Therapy (IT) is acellular product consisting of autologous fibroblasts developed for the treatment of moderate to severe nasolabial fold wrinkles for up to six months in adults. The fibroblasts are derived from patients’ post-auricular skin biopsies, expanded in culture, and suspended in proprietaryisotonic medium. The final cell suspension is injected intradermally into patients’ nasolabial folds. The treatment regimen comprises three sets of injections with a five-week interval betwee