Objectives: The purpose of this research was the generation of data and analysis of results, which characterized the safety and effectiveness of technology of application of dermis autofibroblasts in a 2-year period after application including clinical studies and post-marketing studies. It is particularly interesting to obtain objective knowledge about duration of a synthetic activity of transplanted dermal autofibroblasts and mechanisms of qualitative and quantitative changes, occurring in human skin after their application.
Introduction: Basic molecular mechanisms are associated with the main cell population of the dermis – fibroblasts, which influence the skin aging the most. Due to aging the number of functionally active fibroblasts in the skin decreases, and their bio-synthetic activity is being reduced. The imbalance between the processes of synthesis and degradation of extracellular matrix presents, and collagen level decreases with age. There are only two commercialized technologies which are based on application of autologous dermal fibroblasts: in Russia since July 2010 (“SPRS – therapy”, № 2009/308 from July, 21th 2010, Human Stem Cells Institute) and in the US since July 2011 ( LAVIV, azficel-T, Fibrocell Science, Inc).
Materials / method: 17 patients participated in clinical studies, aged 45-65 years; post-marketing studies included 93 patients, aged 36--65 years. Skin biopsies are performed from post-auricular area in order to isolate autofibroblasts. Cells for injection are prepared in accordance with the medical technology; patients were injected twice with an interval of a 1 month with 60×10*6 (60 mln) сells by linear-retrograde method. Measurement of the results (an optical profilometry, a kutometry, a laser Doppler flowmetry, a comprehensive analysis of the clinical condition of the skin, histological examination ) was carried initially, in 1, 3, 6, 12 and 24 months after the second procedure of intradermal injection of skin's autofibroblasts.
Results: The results of the clinical study indicate that after transplantation, the autofibroblasts are entirely integrate into the derma and their biosynthetic activity persists for at least 12 months. As a result, the dermal microstructure is remodeled: the amount of collagen fibers increases, the skin thickness increases, and the blood microcirculation intensifies. The changes in dermal microstructure clinically manifest as the considerably more elastic and thick skin, while wrinkles are decreasing in number and depth. The clinical effect is developing for 6–8 months and then preserves for at least 2 years. The results of the post-marketing study confirmed the results of the clinical study.
Conclusion: The results of observation demonstrate the safety and clinical effectiveness of application of dermis autofibroblasts for correction of age-related changes of the skin. After transplantation of cultured autofibroblasts in the skin their bio-synthetic potential persists, and they produce extracellular matrix component of the dermis for at least 12 months. As a result, remodeling of the dermis microstructures is observed, which accompanied by an increase of collagen level and thickness of the dermis, and by increase of functional hemomicrocirculation, that is clinically expressed by increase of turgor and thickness of the skin, and by decrease in the number and depth of wrinkles.
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请注明日期: Zorin V. L., Zorina A. I., Terekhov S. M., et al. Biotransplant and a way of correcting soft tissue defects. A way of obtaining biotransplant. Patent for invention RU 2281776
和审阅情况: 2006
这项工作没有任何直接或间接的资金支持。由作者自己承担责任。