Terapevticheskii arkhivTerapevticheskii arkhivТерапевтический архив0040-36602309-5342LLC Obyedinennaya Redaktsiya31691Editorial articleПередовая статьяResearch ArticleSafety of mesenchymal stromal cell therapy for inflammatory bowel diseases: Results of a 5-year follow-upБезопасность терапии воспалительных заболеваний кишечника с применением мезенхимальных стромальных клеток: результаты 5-летнего наблюденияKniazevO VКнязевО ВParfenovA IПарфеновА ИKonopliannikovA GКоноплянниковА ГRuchkinaI NРучкинаИ НChurikovaA AЧуриковаА АBykovaS VБыковаС ВAlbulovaE AАлбуловаЕ АBoldyrevaO NБолдыреваО НFadeevaN AФадееваН АLishchinskaiaA AЛищинскаяА АГБУЗ "Московский клинический научно-практический центр" Департамента здравоохранения Москвы, Москва, РоссияФГБУ "Медицинский радиологический научный центр" Минздрава России, Обнинск, Россия15022015872VOL 87, NO2 ()ТОМ 87, №2 (2015)394410042020Copyright ©; 2015, Consilium MedicumCopyright ©; 2015, ООО "Консилиум Медикум"2015Consilium MedicumООО "Консилиум Медикум"https://creativecommons.org/licenses/by-nc-sa/4.0https://ter-arkhiv.ru/0040-3660/article/view/31691

Aim. To compare the safety of therapy in patients with ulcerative colitis (UC) and Crohn's disease (CD) who have received combination anti-inflammatory therapy using bone marrow mesenchymal stromal cells (MSC) and standard therapy with 5-aminosalicylic acid, glucocorticosteroids, and immunosuppressive agents. Subjects and methods. Unfavorable consequences were analyzed in 103 patients (56 with UC and 47 with CD) with inflammatory bowel disease (IBD) after MSC administration. The findings were compared with data obtained in 208 patients with UC and CD on standard anti-inflammatory therapy. All the patients were similar in demographic parameters, the duration of disease, the extent of intestinal injury, the nature of a course, the type and degree of disease. The analyzed groups did not include patients who had received therapy with anti-TNF-α drugs. The safety of therapy was evaluated from the presence of complications occurring during the follow-up. Results. By analyzing the unfavorable consequences in 103 patients with IBD and comparing them with treatment results in 208 patients with UC and CD on standard anti-inflammatory therapy, the authors revealed no differences in the development of acute posttransfusion reactions, infectious complications, exacerbations of chronic inflammatory diseases, severe infectious complications, malignant transformation, and fatal cases in patients with UC and CD, except for those with transient fever. Conclusion. The results of this study demonstrate that the innovative method of cell therapy is clinically safe.

Резюме. Цель исследования. Сравнить безопасность терапии у больных язвенным колитом (ЯК) и болезнью Крона (БК), получавших комплексную противовоспалительную терапию с применением мезенхимальных стромальных клеток (МСК) костного мозга, и стандартную терапию препаратами 5-аминосалициловой кислоты, глюкокортикостероидами и иммуносупрессорами. Материалы и методы. Неблагоприятные последствия проанализированы у 103 больных (56 с ЯК и 47 с БК) воспалительными заболеваниями кишечника (ВЗК), которым вводили МСК. Полученные результаты сравнили с данными, полученными у 208 пациентов с ЯК и БК, которые находились на стандартной противовоспалительной терапии. Все пациенты сопоставимы по демографическим параметрам, длительности заболевания, протяженности поражения кишечника, характеру течения, форме заболевания, степени тяжести. В анализируемые группы не включали больных, которые получали терапию анти-α-ФНО-препаратами. Безопасность терапии оценивали по наличию осложнений, возникших за время наблюдения. Результаты. Проведя анализ неблагоприятных последствий у 103 больных ВЗК, которым вводили МСК, и сравнив их с результатами лечения 208 больных ЯК и БК, получавших стандартную противовоспалительную терапию, мы не выявили различий в развитии острых посттрансфузионных реакций, инфекционных осложнений, обострений хронических воспалительных заболеваний, тяжелых инфекционных осложнений, злокачественной трансформации и смертельных случаев у больных ЯК и БК, за исключением транзиторной лихорадки. Заключение. Результаты нашего исследования демонстрируют, что инновационный метод клеточной терапии является безопасным для клинического применения.

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