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<article article-type="review-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">10.33380/2305-2066-2024-13-2-1727</article-id><article-id custom-type="elpub" pub-id-type="custom">pharmjournal-1789</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>ПОИСК И РАЗРАБОТКА НОВЫХ ЛЕКАРСТВЕННЫХ СРЕДСТВ</subject></subj-group><subj-group subj-group-type="section-heading" xml:lang="en"><subject>RESEARCH AND DEVELOPMENT OF NEW DRUG PRODUCTS</subject></subj-group></article-categories><title-group><article-title>Современные аспекты наружного применения и перспективы использования секретома мезенхимальных стволовых клеток (обзор)</article-title><trans-title-group xml:lang="en"><trans-title>Modern aspects of external application and prospects of using the secretome of mesenchymal stem cells (review)</trans-title></trans-title-group></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><contrib-id contrib-id-type="orcid">https://orcid.org/0000-0001-8695-0346</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Бахрушина</surname><given-names>Е. О.</given-names></name><name name-style="western" xml:lang="en"><surname>Bakhrushina</surname><given-names>E. O.</given-names></name></name-alternatives><bio xml:lang="ru"><p>119991, г. Москва, ул. Трубецкая, д. 8, стр. 2</p></bio><bio xml:lang="en"><p>8/2, Trubetskaya str., Mosсow, 119991</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/0000-0002-3735-2291</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Гравель</surname><given-names>И. В.</given-names></name><name name-style="western" xml:lang="en"><surname>Gravel</surname><given-names>I. V.</given-names></name></name-alternatives><bio xml:lang="ru"><p>119991, г. Москва, ул. Трубецкая, д. 8, стр. 2</p></bio><bio xml:lang="en"><p>8/2, Trubetskaya str., Mosсow, 119991</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/0009-0007-7660-2090</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Филиппова</surname><given-names>О. С.</given-names></name><name name-style="western" xml:lang="en"><surname>Filippova</surname><given-names>O. S.</given-names></name></name-alternatives><bio xml:lang="ru"><p>119991, г. Москва, ул. Трубецкая, д. 8, стр. 2</p></bio><bio xml:lang="en"><p>8/2, Trubetskaya str., Mosсow, 119991</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/0009-0001-5464-9337</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Тычинин</surname><given-names>В. Н.</given-names></name><name name-style="western" xml:lang="en"><surname>Tychinin</surname><given-names>V. N.</given-names></name></name-alternatives><bio xml:lang="ru"><p>117997, г. Москва, ул. Островитянова, д. 1</p></bio><bio xml:lang="en"><p>1, Ostrovityanova str., Moscow, 117997</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/0000-0002-3874-8626</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Попова</surname><given-names>А. А.</given-names></name><name name-style="western" xml:lang="en"><surname>Popova</surname><given-names>A. A.</given-names></name></name-alternatives><bio xml:lang="ru"><p>119991, г. Москва, ул. Трубецкая, д. 8, стр. 2</p></bio><bio xml:lang="en"><p>8/2, Trubetskaya str., Mosсow, 119991</p></bio><email xlink:type="simple">popova_a_a_1@staff.sechenov.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/0009-0004-3852-0842</contrib-id><name-alternatives><name name-style="eastern" xml:lang="ru"><surname>Добровольский</surname><given-names>О. Б.</given-names></name><name name-style="western" xml:lang="en"><surname>Dobrovolsky</surname><given-names>O. B.</given-names></name></name-alternatives><bio xml:lang="ru"><p>119991, г. Москва, ул. Трубецкая, д. 8, стр. 2</p></bio><bio xml:lang="en"><p>8/2, Trubetskaya str., Mosсow, 119991</p></bio><xref ref-type="aff" rid="aff-1"/></contrib></contrib-group><aff-alternatives id="aff-1"><aff xml:lang="ru">Федеральное государственное автономное образовательное учреждение высшего образования «Первый Московский государственный медицинский университет имени И. М. Сеченова» Министерства здравоохранения Российской Федерации (Сеченовский Университет)<country>Россия</country></aff><aff xml:lang="en">I. M. Sechenov First MSMU of the Ministry of Health of the Russian Federation (Sechenov University)<country>Russian Federation</country></aff></aff-alternatives><aff-alternatives id="aff-2"><aff xml:lang="ru">Федеральное государственное автономное образовательное учреждение высшего образования «Российский национальный исследовательский медицинский университет имени Н. И. Пирогова» Министерства здравоохранения Российской Федерации (ФГАОУ ВО РНИМУ им. Н. И. Пирогова Минздрава России)<country>Россия</country></aff><aff xml:lang="en">N. I. Pirogov Russian National Research Medical University (Pirogov RNRMU)<country>Russian Federation</country></aff></aff-alternatives><pub-date pub-type="collection"><year>2024</year></pub-date><pub-date pub-type="epub"><day>25</day><month>03</month><year>2024</year></pub-date><volume>13</volume><issue>2</issue><fpage>34</fpage><lpage>47</lpage><permissions><copyright-statement>Copyright &amp;#x00A9; Бахрушина Е.О., Гравель И.В., Филиппова О.С., Тычинин В.Н., Попова А.А., Добровольский О.Б., 2024</copyright-statement><copyright-year>2024</copyright-year><copyright-holder xml:lang="ru">Бахрушина Е.О., Гравель И.В., Филиппова О.С., Тычинин В.Н., Попова А.А., Добровольский О.Б.</copyright-holder><copyright-holder xml:lang="en">Bakhrushina E.O., Gravel I.V., Filippova O.S., Tychinin V.N., Popova A.A., Dobrovolsky O.B.</copyright-holder><license 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/1789">https://www.pharmjournal.ru/jour/article/view/1789</self-uri><abstract><sec><title>Введение</title><p>Введение. Cекретом мезенхимальных стволовых клеток (СМСК) находит широкое применение в практической медицине. Он используется за счет своих иммунномодулирующих и регенеративных свойств в лечении аутоиммунных, иммуноопосредованных, а также некоторых других заболеваний благодаря противовоспалительному, нейропротективному и регенерирующему действию. В последние годы возрос интерес к разработке средств для наружного применения, содержащих СМСК. Подобные препараты планируется применять в лечении диабетических ран, для регенерации кожи, лечения воспалительных заболеваний, а также алопеции. Имеются множественные исследования, подтверждающие значительный потенциал для применения СМСК в дерматологии и косметологии. Целью данного обзора являлось изучение потенциала использования кондиционной среды в составе лекарственных средств для наружного применения, подходов к стандартизации СМСК в качестве фармацевтической субстанции и методов увеличения ее чрескожной доставки.</p></sec><sec><title>Текст</title><p>Текст. СМСК как активный фармацевтический ингредиент представляет собой прозрачную жидкость от желтого до оранжевого цвета с характерным запахом. рН готового к введению в композиции СМСК составляет от 7,0 до 7,5, что позволяет использовать его в средствах для местного и наружного применения без добавления стабилизаторов или корректоров рН. Проблемы доставки СМСК через эпидермис чаще всего решают помещением секретома в гидрогели, использованием экзосом или технологии с использованием микроигл. С 2022 года после внесения изменений на законодательном уровне были приняты меры по регистрации и внедрению в клиническую практику отечественных препаратов на основе клеточных продуктов. Однако, как показал анализ, до появления оригинальных лекарственных средств на основе СМСК пройдет еще некоторое время. На сегодняшний день в Российской Федерации производятся продукты, относящиеся к косметическим средствам и ветеринарным препаратам, а также зоокосметическим средствам.</p></sec><sec><title>Заключение</title><p>Заключение. СМСК может быть использован в качестве субстанции для потенциального лечения широкого спектра острых и хронических заболеваний. Но несмотря на большое количество положительных результатов применения СМСК в заживлении ран у животных, а также клинических исследований по изучению влияния на регенерацию кожи, отсутствуют исследования его безопасности, эффективности и стандартизации процесса производства фармацевтической субстанции.</p></sec></abstract><trans-abstract xml:lang="en"><sec><title>Introduction</title><p>Introduction. The secretome of mesenchymal stem cells (SMSC) is widely used in medicine. It is most often used due to its immune-modulating and regenerative properties in the treatment of autoimmune, immuno-mediated and other diseases due to its anti-inflammatory, neuroprotective and regenerating action. In many studies, exosomes isolated from SMSC are used as a therapeutic agent. In recent years, the interest in the development of products containing SMSC for external use has increased. Similar drugs are planned to be used in the treatment of diabetic wounds, for skin regeneration, the treatment of inflammatory diseases, as well as alopecia. There are multiple studies on increasing collagen secretion and reducing skin photosensitivity in preclinical studies, which confirms the significant potential for the use of SMSC in dermatology and cosmetology. The purpose of this review was to study the potential of using conditioned medium in medicines for external use, approaches to standardization of SMSC as a pharmaceutical substance and methods of increasing percutaneous delivery.</p></sec><sec><title>Text</title><p>Text. SMSC as an active pharmaceutical ingredient is a transparent liquid from yellow to orange in color with a characteristic odor. The pH of the ready-to-use SMSC composition ranges from 7.0 to 7.5, which allows it to be used in topical and external applications without the addition of stabilizers or pH correctors. Problems of delivery of SMSC through the epidermis are most often solved by placing the secretome in hydrogels, using exosomes or technology using microneedles. Since 2022, after legislative changes, measures have been taken to register and introduce into clinical practice domestic drugs based on cellular products. However, as the analysis showed, it will take some time before the appearance of original medicines based on SMSC, and today in the Russian Federation only products related to cosmetics and veterinary drugs, as well as zoocosmetics, are produced so far.</p></sec><sec><title>Conclusion</title><p>Conclusion. SMSC may also prove to be a safer and more effective substance for the potential treatment of a wide range of acute and chronic diseases. But despite the large number of positive results of using SMSC for wound healing in animals, as well as clinical studies on skin regeneration, there are no studies of its safety and effectiveness, as well as standardization of the production process.</p></sec></trans-abstract><kwd-group xml:lang="ru"><kwd>секретом мезенхимальных стволовых клеток</kwd><kwd>кондиционная среда</kwd><kwd>факторы роста</kwd><kwd>экзосомы</kwd><kwd>наружное применение</kwd><kwd>атопический дерматит</kwd><kwd>космецевтика</kwd></kwd-group><kwd-group xml:lang="en"><kwd>secretome of mesenchymal stem cells</kwd><kwd>conditioned medium</kwd><kwd>exosomes</kwd><kwd>external use</kwd><kwd>atopic dermatitis</kwd><kwd>regeneration</kwd><kwd>cosmeceutics</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">Teixeira F. G., Salgado A. J. Mesenchymal stem cells secretome: current trends and future challenges. 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