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<article article-type="research-article" dtd-version="1.3" xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance" xml:lang="ru"><front><journal-meta><journal-id journal-id-type="publisher-id">pharmjournal</journal-id><journal-title-group><journal-title xml:lang="ru">Разработка и регистрация лекарственных средств</journal-title><trans-title-group xml:lang="en"><trans-title>Drug development &amp; registration</trans-title></trans-title-group></journal-title-group><issn pub-type="ppub">2305-2066</issn><issn pub-type="epub">2658-5049</issn><publisher><publisher-name>LLC «CPHA»</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="doi">10.33380/2305-2066-2025-14-3-2123</article-id><article-id custom-type="elpub" pub-id-type="custom">pharmjournal-2168</article-id><article-categories><subj-group subj-group-type="heading"><subject>Research Article</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="ru"><subject>ДОКЛИНИЧЕСКИЕ И КЛИНИЧЕСКИЕ ИССЛЕДОВАНИЯ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>PRECLINICAL AND CLINICAL STUDIES</subject></subj-group></article-categories><title-group><article-title>Эффективность применения экзосом на модели хронического кожного поражения in vivo</article-title><trans-title-group xml:lang="en"><trans-title>Efficacy of exosomes in a chronic skin lesion model in vivo</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-8512-3736</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Глазко</surname><given-names>И. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Glazko</surname><given-names>I. I.</given-names></name></name-alternatives><bio xml:lang="ru"><p>123098, г. Москва, ул. Маршала Новикова, д. 23</p></bio><bio xml:lang="en"><p>23, Marshala Novikova str., Moscow, 123098</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0002-7115-538X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Дубова</surname><given-names>Е. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Dubova</surname><given-names>E. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>123098, г. Москва, ул. Маршала Новикова, д. 23</p></bio><bio xml:lang="en"><p>23, Marshala Novikova str., Moscow, 123098</p></bio><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-5545-135X</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Балакин</surname><given-names>И. Е.</given-names></name><name name-style="western" xml:lang="en"><surname>Balakin</surname><given-names>E. I.</given-names></name></name-alternatives><bio xml:lang="ru"><p>123098, г. Москва, ул. Маршала Новикова, д. 23</p></bio><bio xml:lang="en"><p>23, Marshala Novikova str., Moscow, 123098</p></bio><email xlink:type="simple">evgbalakin@yandex.ru</email><xref ref-type="aff" rid="aff-1"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-9134-7189</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Рукодайный</surname><given-names>О. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Rukodayny</surname><given-names>O. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>Факультет непрерывного медицинского образования, Медицинский институт</p><p>117198, г. Москва, ул. Миклухо-Маклая, д. 6</p></bio><bio xml:lang="en"><p>6, Miklukho-Maklaya str., Moscow, 117198</p></bio><xref ref-type="aff" rid="aff-2"/></contrib><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0003-3396-5813</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Пустовойт</surname><given-names>В. И.</given-names></name><name name-style="western" xml:lang="en"><surname>Pustovoit</surname><given-names>V. I.</given-names></name></name-alternatives><bio xml:lang="ru"><p>123098, г. Москва, ул. Маршала Новикова, д. 23</p></bio><bio xml:lang="en"><p>23, Marshala Novikova str., Moscow, 123098</p></bio><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru"><institution>Федеральное государственное бюджетное учреждение «Государственный научный центр Российской Федерации – Федеральный медицинский биофизический центр им. А. И. Бурназяна» (ФГБУ ГНЦ ФМБЦ им. А. И. Бурназяна ФМБА России)</institution></aff><aff xml:lang="en"><institution>Federal Medical Biophysical Center named after A. I. Burnazyan of Federal Medical Biological Agency of Russia</institution></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru"><institution>Федеральное государственное автономное образовательное учреждение высшего образования «Российский университет дружбы народов имени Патриса Лумумбы» Министерства науки и высшего образования Российской Федерации</institution></aff><aff xml:lang="en"><institution>Institute of Medicine, RUDN University</institution></aff></aff-alternatives><pub-date pub-type="collection"><year>2025</year></pub-date><pub-date pub-type="epub"><day>02</day><month>09</month><year>2025</year></pub-date><volume>14</volume><issue>3</issue><fpage>196</fpage><lpage>204</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Глазко И.И., Дубова Е.А., Балакин И.Е., Рукодайный О.В., Пустовойт В.И., 2025</copyright-statement><copyright-year>2025</copyright-year><copyright-holder xml:lang="ru">Глазко И.И., Дубова Е.А., Балакин И.Е., Рукодайный О.В., Пустовойт В.И.</copyright-holder><copyright-holder xml:lang="en">Glazko I.I., Dubova E.A., Balakin E.I., Rukodayny O.V., Pustovoit V.I.</copyright-holder><license xml:lang="ru" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>Данная работа распространяется под лицензией Creative Commons Attribution 4.0.</license-p></license><license xml:lang="en" license-type="creative-commons-attribution" xlink:href="https://creativecommons.org/licenses/by/4.0/" xlink:type="simple"><license-p>This work is licensed under a Creative Commons Attribution 4.0 License.</license-p></license></permissions><self-uri xlink:href="https://www.pharmjournal.ru/jour/article/view/2168">https://www.pharmjournal.ru/jour/article/view/2168</self-uri><abstract><sec><title>Введение</title><p>Введение. Хронические язвы кожи, включая радиационно-индуцированные, связаны с нарушением регенерации, хроническим воспалением и высоким риском осложнений, что требует новых подходов к лечению из-за низкой эффективности традиционных методов. Современные методы регенеративной медицины, такие как применение биополимерных покрытий и экзосомальных препаратов, способствуют восстановлению тканей за счет улучшения микроокружения, стимуляции клеточной активности и модуляции воспаления.</p></sec><sec><title>Цель</title><p>Цель. Разработка модели хронического радиационно-индуцированного кожного поражения и оценка эффективности экзосом, произведенных в клинике регенеративной медицины «Новейшая медицина», монотерапии медицинским изделием (МИ) СФЕРО®гель, а также их комбинированного применения у лабораторных животных.</p></sec><sec><title>Материалы и методы</title><p>Материалы и методы. В эксперименте использовали 48 крыс стока Wistar, которым моделировали хроническое кожное поражение посредством фракционированного рентгеновского облучения (5 × 10 Гр), механической травмы и индукции стойкого воспаления [введение липополисахарида (LPS)]. Животные были рандомизированы на четыре группы: контрольную, МИ СФЕРО®гель, экзосомы и комбинированную терапию. Лечение проводили в течение 28 суток. Эффективность оценивали с помощью морфометрии язвенной поверхности (ImageJ) и гистологического анализа.</p></sec><sec><title>Результаты и обсуждение</title><p>Результаты и обсуждение. Применение экзосом («Новейшая медицина») и МИ СФЕРО®гель значительно ускоряло процессы репарации, снижало выраженность фиброза и воспаления. Комбинированная терапия обеспечила полную эпителизацию у 75 % животных, нормализацию ангиогенеза и восстановление дермальной структуры.</p></sec><sec><title>Заключение</title><p>Заключение. Комбинированное применение МИ СФЕРО®гель и экзосом («Новейшая медицина») оказывает синергетический эффект в терапии хронических радиационных язв, что подтверждает перспективность данного подхода для клинической трансляции в восстановительной медицине.</p></sec></abstract><trans-abstract xml:lang="en"><sec><title>Introduction</title><p>Introduction. Chronic skin ulcers, including radiation-induced ones, are associated with impaired regeneration, chronic inflammation and a high risk of complications, which requires new approaches to treatment due to the low efficiency of traditional methods. Modern methods of regenerative medicine, such as application of biopolymer coatings and exosomal drugs, promote tissue restoration by improving the microenvironment, stimulating cellular activity and modulating inflammation.</p></sec><sec><title>Aim</title><p>Aim. To develop a model of chronic radiation-induced skin injury and assess the therapeutic efficacy of monotherapy with medical device SPHERO®gel, exosome therapy (manufactured by New Medicine Stem Cell Clinic), and their combination in laboratory animals.</p></sec><sec><title>Materials and methods</title><p>Materials and methods. The study involved 48 male Wistar rats subjected to fractionated X-ray irradiation (5 × 10 Gy), mechanical skin injury, and persistent inflammation induced by lipopolysaccharide (LPS) injection. Animals were randomized into four groups: control, SPHERO®gel, exosomes (manufactured by New Medicine Stem Cell Clinic), and combined treatment. Therapy was applied for 28 days. Wound healing efficacy was evaluated using ulcer area morphometry (ImageJ) and histological examination.</p></sec><sec><title>Results and discussion</title><p>Results and discussion. Both SPHERO®gel and exosome (New Medicine Stem Cell Clinic) therapy significantly enhanced tissue repair, reduced fibrosis and inflammation. The combined therapy resulted in complete epithelialization in 75 % of animals, normalized angiogenesis, and restored dermal architecture.</p></sec><sec><title>Conclusion</title><p>Conclusion. The combination of SPHERO®gel and exosomes (manufactured by New Medicine Stem Cell Clinic) demonstrates a synergistic effect in the treatment of chronic radiation-induced ulcers and holds promise for clinical application in regenerative and restorative medicine.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>хронические язвы кожи</kwd><kwd>радиационные повреждения</kwd><kwd>СФЕРО®гель</kwd><kwd>фракционированное облучение</kwd><kwd>регенеративная терапия</kwd><kwd>восстановительная медицина</kwd></kwd-group><kwd-group xml:lang="en"><kwd>chronic skin ulcers</kwd><kwd>radiation injury</kwd><kwd>SPHERO®gel</kwd><kwd>fractionated irradiation</kwd><kwd>regenerative therapy</kwd><kwd>restorative medicine</kwd></kwd-group></article-meta></front><back><ref-list><title>References</title><ref id="cit1"><label>1</label><citation-alternatives><mixed-citation xml:lang="ru">Yang X., Ren H., Guo X., Hu C., Fu J. Radiation-induced skin injury: pathogenesis, treatment, and management. 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