spbmedicalrecordsНовые Санкт-Петербургские врачебные ведомостиNew St. Petersburg Medical Records1609-2201Первый Санкт-Петербургский государственный медицинский университет имени академика И.П. Павлова10.24884/1609-2201-2026-105-1-11-18spbmedicalrecords-123Research ArticleКОНСЕНСУСCONSENSUSПовышение доступности применения высокодозной иммуносупрессивной терапии с аутологичной трансплантацией гемопоэтических стволовых клеток (вист-атгск) пациентам с системными аутоиммунными заболеваниями (рассеянный склероз (g35), системная склеродермия (м34), болезнь Крона (к50)). Резолюция Совета экспертов по аутоиммунным заболеваниямIncreasing the availability of high-dose immunosuppressive therapy with autologous hematopoietic stem cell transplantation (wist-atgsc) in patients with systemic autoimmune diseases (multiple sclerosis (g35), systemic scleroderma (m34), Сrohn's disease (k50)). Resolution of the council of experts on autoimmune diseasesГруппа авторов.Group of authors.
Санкт-Петербург, ул. Кораблестроителей, 14, 199226
St. Petersburg, Korablestroiteley str., 14,199226
I Конгресс Национального общества трансплантации гемопоэтических стволовых клеток, генной и клеточной терапииРоссияI Congress of the National Society for Hematopoietic Stem Cell Transplantation, Gene and Cell TherapyRussian Federation202608072026011118Copyright © Группа авторов .., 20262026Группа авторов ..Group of authors ..Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.docved.ru/jour/article/view/123
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трансплантация гемопоэтических стволовых клетокгенная и клеточная терапияаутоиммунные заболеванияhematopoietic stem cell transplantationgene and cell therapyautoimmune diseasesReferencesSharrack B., Saccardi R., Alexander T. et al. European Society for Blood and Marrow Transplantation (EBMT) Autoimmune Diseases Working Party (ADWP) and the Joint Accreditation Committee of the International Society for Cellular Therapy (ISCT) and EBMT (JACIE). Autologous haematopoietic stem cell transplantation and other cellular therapy in multiple sclerosis and immunemediated neurological diseases: updated guidelines and recommendations from the EBMT Autoimmune Diseases Working Party (ADWP) and the Joint Accreditation Committee of EBMT and ISCT (JACIE) // Bone Marrow Transplant. 2020. Vol. 55, № 2. P. 283–306. https://doi.org/10.1038/s41409-019-0684-0.Sharrack B., Saccardi R., Alexander T. et al. European Society for Blood and Marrow Transplantation (EBMT) Autoimmune Diseases Working Party (ADWP) and the Joint Accreditation Committee of the International Society for Cellular Therapy (ISCT) and EBMT (JACIE). Autologous haematopoietic stem cell transplantation and other cellular therapy in multiple sclerosis and immune-mediated neurological diseases: updated guidelines and recommendations from the EBMT Autoimmune Diseases Working Party (ADWP) and the Joint Accreditation Committee of EBMT and ISCT (JACIE). Bone Marrow Transplant. 2020;55(2):283–306. https://doi.org/10.1038/s41409-019-0684-0.Comi G., Kappos L., Clanet M. et al. Guidelines for autologous blood and marrow stem cell transplantation in multiple sclerosis: a consensus report written on behalf of the European Group for Blood and Marrow Transplantation and the European Charcot Foundation // J. Neurol. 2000. Vol. 247. P. 376–382. https://doi.org/10.1007/s004150050605.Comi G., Kappos L., Clanet M. et al. Guidelines for autologous blood and marrow stem cell transplantation in multiple sclerosis: a consensus report written on behalf of the European Group for Blood and Marrow Transplantation and the European Charcot Foundation. J. Neurol. 2000;247:376–382. https://doi.org/10.1007/s004150050605.Duarte R. F., Labopin M., Bader P. et al. Indications for haematopoietic stem cell transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe // Bone Marrow Transplant. 2019. Vol. 54, № 10. P. 1525–1552. https://doi.org/10.1038/s41409-019-0516-2.Duarte R. F., Labopin M., Bader P. et al. Indications for haematopoietic stem cell transplantation for haematological diseases, solid tumours and immune disorders: current practice in Europe. Bone Marrow Transplant. 2019;54(10):1525–1552. https://doi.org/10.1038/s41409-019-0516-2.Cohen J. A., Baldassari L. E., Atkins H. L. et al. Autologous hematopoietic cell transplantation for treatment-refractory relapsing multiple sclerosis: position statement from the American Society for Blood and Marrow Transplantation // Biol Blood Marrow Transplant. 2019. Vol. 25. P. 845–54. https://doi.org/10.1016/j.bbmt.2019.02.014.Cohen J. A., Baldassari L. E., Atkins H. L. et al. Autologous hematopoietic cell transplantation for treatment-refractory relapsing multiple sclerosis: position statement from the American Society for Blood and Marrow Transplantation. Biol Blood Marrow Transplant. 2019;25:845–54. https://doi.org/10.1016/j.bbmt.2019.02.014.Полушин А. Ю., Залялов Ю. Р., Тотолян Н. А. и др. Высокодозная иммуносупрессивная терапия с аутологичной трансплантацией гемопоэтических стволовых клеток при рассеянном склерозе: современный взгляд на метод (обзор литературы) // Ученые записки СПбГМУ им. акад. И. П. Павлова. 2021. Т. 28, № 4. С. 9–21. https://doi.org/10.24884/1607-41812021-28-4-9-21.Polushin A. Yu., Zalyalov Yu. R., Totolyan N. A. et al. High-dose immunosuppressive therapy with autologous hematopoietic stem cell transplantation in multiple sclerosis: a modern view of the method (review of literature). The Scientific Notes of the Pavlov University. 2021;28(4):9–21. (In Russ.). https://doi.org/10.24884/1607-4181-202128-4-9-21.Muraro P. A., Mariottini A., Greco R. et al. Autologous haematopoietic stem cell transplantation for treatment of multiple sclerosis and neuromyelitisoptica spectrum disorder - recommendations from ECTRIMS and the EBMT // Nat Rev Neurol. 2025. Vol. 21, № 3. P. 140–158. https://doi.org/10.1038/s41582-024-01050-x. PMID: 39814869.Muraro P. A., Mariottini A., Greco R. et al. Autologous haematopoietic stem cell transplantation for treatment of multiple sclerosis and neuromyelitisoptica spectrum disorder – recommendations from ECTRIMS and the EBMT. Nat Rev Neurol. 2025;21(3):140–158. https://doi.org/10.1038/s41582-024-01050-x. PMID: 39814869.Greco R., Ruggeri A., McLornan D. P. et al. Indications for haematopoietic cell transplantation and CAR-T for haematological diseases, solid tumours and immune disorders: 2025 EBMT practice recommendations // Bone Marrow Transplant. 2025. Vol. 60, № 11. P. 1499–1525. https://doi.org/10.1038/s41409-025-02701-3. PMID: 40926035.Greco R., Ruggeri A., McLornan D. P. et al. Indications for haematopoietic cell transplantation and CAR-T for haematological diseases, solid tumours and immune disorders: 2025 EBMT practice recommendations. Bone Marrow Transplant. 2025;60(11):1499–1525. https://doi.org/10.1038/s41409-025-02701-3. PMID: 40926035.Полушин А. Ю., Залялов Ю. Р., Тотолян Н. А. и др. Высокодозная иммуносупрессивная терапия с аутологичной трансплантацией гемопоэтических стволовых клеток при рассеянном склерозе: перспективы снижения рисков // Анналы клинической и экспериментальной неврологии. 2022. Т. 16, № 3. С. 53–64. https://doi.org/10.54101/ACEN.2022.3.7.Polushin A. Yu., Zalyalov Yu. R., Totolyan N. A. et al. High-dose immunosuppressive therapy with autologous hematopoietic stem cell transplantation in multiple sclerosis: approaches to risk management. Annals of Clinical and Experimental Neurology. 2022;16(3):53–64. (In Russ.). https://doi.org/10.54101/ACEN.2022.3.7.Полушин А. Ю., Залялов Ю. Р., Гавриленко А. Н. и др. Высокодозная иммуносупрессивная терапия с аутологичной трансплантацией гемопоэтических стволовых клеток при рассеянном склерозе: предварительные клинические результаты апробации метода в ПСПбГМУ им. И. П. Павлова // Российский неврологический журнал. 2022. Т. 27, № 5. С. 25–35. https://doi.org/10.30629/2658-7947-2022-27-5-25-35.Polushin A. Yu., Zalyalov Yu. R., Gavrilenko A. N. et al. High-dose immunosuppressive therapy with autologous hematopoietic stem cell transplantation in multiple sclerosis: preliminary clinical results of approbation of the method. Russian neurological journal. 2022;27(5):25–35. (In Russ.). https://doi.org/10.30629/2658-7947-2022-27-5-25-35.Полушин А. Ю., Лопатина Е. И., Цынченко А. А. и др. Анализ качества жизни и симптомов у пациентов с рассеянным склерозом в течение 3 лет после высокодозной иммуносупрессивной терапии с аутологичной трансплантацией гемопоэтических стволовых клеток // Ученые записки ПСПбГМУ им. акад. И. П. Павлова. 2024. Т. 31, № 2. С. 44–55. https://doi.org/10.24884/1607-41812024-31-2-44-55.Polushin A. Yu., Lopatina E. I., Tsynchenko A. A. et al. Analysis of the quality of life in patients with multiple sclerosis within 3 years after high-dose immunosuppressive therapy with autologous hematopoietic stem cell transplantation. The Scientific Notes of the Pavlov University. 2024;31(2):44–55. (In Russ.). https://doi.org/10.24884/16074181-2024-31-2-44-55.Murrieta-Álvarez I., Cantero-Fortiz Y., León-Peña A. A. et al. The 1,000th Transplant for Multiple Sclerosis and Other Autoimmune Disorders at the HSCT-México Program: A Myriad of Experiences and Knowledge // Front Neurol. 2021. Vol. 12. P. 647425. https://doi.org/10.3389/fneur.2021.647425. PMID: 33692748; PMCID: PMC7937693.Murrieta-Álvarez I., Cantero-Fortiz Y., León-Peña A. A. et al. The 1,000th Transplant for Multiple Sclerosis and Other Autoimmune Disorders at the HSCTMéxico Program: A Myriad of Experiences and Knowledge. Front Neurol. 2021;12:647425. https://doi.org/10.3389/fneur.2021.647425. PMID: 33692748; PMCID: PMC7937693.Киргизов К. И., Скоробогатова Е. В., Бембеева Р. Ц. и др. Аутологичная трансплантация гемопоэтических стволовых клеток у детей с тяжелыми рефрактерными формами рассеянного склероза // Вопросы современной педиатрии. 2013. Т. 12, № 1. С. 149–152. https://doi.org/10.15690/vsp.v12i1.572.Kirgizov K. I., Skorobogatova E. V., Bembeeva R. Ts. et al. Autologous hematopoietic stem cell transplantation in children with severe resistant multiple sclerosis. Current Pediatrics. 2013;12(1):149–152. (In Russ.). https://doi.org/10.15690/vsp.v12i1.572.Burman J., Kirgizov K., Carlson K. et al. Autologous hematopoietic stem cell transplantation for pediatric multiple sclerosis: a registry-based study of the Autoimmune Diseases Working Party (ADWP) and Pediatric Diseases Working Party (PDWP) of the European Society for Blood and Marrow Transplantation (EBMT) // Bone Marrow Transplant. 2017. Vol. 52, № 8. P. 1133–1137. https://doi.org/10.1038/bmt.2017.40. PMID: 28319075.Burman J., Kirgizov K., Carlson K. et al. Autologous hematopoietic stem cell transplantation for pediatric multiple sclerosis: a registry-based study of the Autoimmune Diseases Working Party (ADWP) and Pediatric Diseases Working Party (PDWP) of the European Society for Blood and Marrow Transplantation (EBMT). Bone Marrow Transplant. 2017;52(8):1133–1137. https://doi.org/10.1038/bmt.2017.40. PMID: 28319075.Achini-Gutzwiller F. R., Snowden J. A., Corbacioglu S. et al. Haematopoietic stem cell transplantation for severe autoimmune diseases in children: A review of current literature, registry activity and future directions on behalf of the autoimmune diseases and paediatric diseases working parties of the European Society for Blood and Marrow Transplantation // Br J Haematol. 2022. Vol. 198, № 1. P. 24–45. https://doi.org/10.1111/bjh.18176. PMID: 37655707.Achini-Gutzwiller F. R., Snowden J. A., Corbacioglu S. et al. Haematopoietic stem cell transplantation for severe autoimmune diseases in children: A review of current literature, registry activity and future directions on behalf of the autoimmune diseases and paediatric diseases working parties of the European Society for Blood and Marrow Transplantation. Br J Haematol. 2022;198(1):24–45. https://doi.org/10.1111/bjh.18176. PMID: 37655707.Farge D., Pugnet G., Allez M. et al. French protocol for the diagnosis and management of hematopoietic stem cell transplantation in autoimmune diseases // Rev Med Interne. 2024. Vol. 45, № 2. P. 79–99. https://doi.org/10.1016/j.revmed.2023.12.008.Farge D., Pugnet G., Allez M. et al. French protocol for the diagnosis and management of hematopoietic stem cell transplantation in autoimmune diseases. Rev Med Interne. 2024;45(2):79–99. https://doi.org/10.1016/j.revmed.2023.12.008.Denton C. P., De Lorenzis E., Roblin E. et al. The 2024 British Society for Rheumatology guideline for management of systemic sclerosis // Rheumatology (Oxford). 2024. Vol. 63, № 11. P. 2956–2975. https://doi.org/10.1093/rheumatology/keae394.Denton C. P., De Lorenzis E., Roblin E. et al. The 2024 British Society for Rheumatology guideline for management of systemic sclerosis. Rheumatology (Oxford). 2024;63(11):2956–2975. https://doi.org/10.1093/rheumatology/keae394.Alexander T., Roldan E., Del Papa N. et al. Autologous haematopoietic stem cell transplantation for rheumatic diseases: best practice recommendations from the EBMT Practice Harmonization and Guidelines Committee // Bone Marrow Transplant. 2025. Vol. 60, № 11. P. 1451–1464. https://doi.org/10.1038/s41409-025-02695-y.Alexander T., Roldan E., Del Papa N. et al. Autologous haematopoietic stem cell transplantation for rheumatic diseases: best practice recommendations from the EBMT Practice Harmonization and Guidelines Committee. Bone Marrow Transplant. 2025;60(11):1451–1464. https://doi.org/10.1038/s41409-025-02695-y.Van Laar J. M., Farge D., Sont J. K. et al. Autologous haemopoetic stem cell transplantation vs intravenous pulse cyclophosphamide in diffuse cutaneous systemic sclerosis: a ran domized clinical trial // JAMA. 2014. Vol. 311, № 24. P. 2490–8. https://doi.org/10.1001/jama.2014.6368.Van Laar J. M., Farge D., Sont J. K. et al. Autologous haemopoetic stem cell transplantation vs intravenous pulse cyclophosphamide in diffuse cutaneous systemic sclerosis: a ran domized clinical trial. JAMA. 2014;311(24):2490–8. https://doi.org/10.1001/jama.2014.6368.Burt R. K., Shah S. J., Dill K. et al. Autologous non-myeloablativehemotopoetic stem-cell transplantation compared with pulse cyclophosphamide once per months for systemic sclerosis (ASSIST): an open label. Randomized phase 2 trial // Lancet. 2011. Vol. 378, № 9790. P. 498–506. https://doi.org/10.1016/S01406736(11)60982-3.Burt R. K., Shah S. J., Dill K. et al. Autologous non-myeloablativehemotopoetic stem-cell transplantation compared with pulse cyclophosphamide once per months for systemic sclerosis (ASSIST): an open label. Randomized phase 2 trial. Lancet. 2011;378(9790):498–506. https://doi.org/10.1016/S01406736(11)60982-3.Sullivan K. M., Goldmuntz E. A., Keyes-Elstein L. et al. Myeloablative Autologous Stem-Cell Transplantation for Severe Scleroderma // The New England journal of medicine. 2018. Vol. 378, № 1. P. 35–47.Sullivan K. M., Goldmuntz E. A., Keyes-Elstein L. et al. Myeloablative Autologous Stem-Cell Transplantation for Severe Scleroderma. The New England journal of medicine. 2018;378(1):35–47.Snowden J. A., Hawkey C., Hind D. et al. Autologous Stem Cell Transplantation In Refractory CD - Low Intensity Therapy Evaluation Study Investigators; European Society for Blood and Marrow Transplantation (EBMT) Autoimmune Diseases Working Party (ADWP). Autologous stem cell transplantation in refractory Crohn’s disease - low intensity therapy evaluation (ASTIClite): study protocols for a multicentre, randomised controlled trial and observational follow up study // BMC Gastroenterol. 2019. Vol. 19, № 1. P. 82. https://doi.org/10.1186/s12876-019-0992-2.Snowden J. A., Hawkey C., Hind D. et al. Autologous Stem Cell Transplantation In Refractory CD - Low Intensity Therapy Evaluation Study Investigators; European Society for Blood and Marrow Transplantation (EBMT) Autoimmune Diseases Working Party (ADWP). Autologous stem cell transplantation in refractory Crohn’s disease - low intensity therapy evaluation (ASTIClite): study protocols for a multicentre, randomised controlled trial and observational follow up study. BMC Gastroenterol. 2019;19(1):82. https://doi.org/10.1186/s12876-019-0992-2.Pockley A. G., Lindsay J. O., Foulds G. A. et al. Immune Reconstitution After Autologous Hematopoietic Stem Cell Transplantation in Crohn’s Disease: Current Status and Future Directions. A Review on Behalf of the EBMT Autoimmune Diseases Working Party and the Autologous Stem Cell Transplantation In Refractory CD-Low Intensity Therapy Evaluation Study Investigators // FrontImmunol. 2018. Vol. 9. P. 646. https://doi.org/10.3389/fimmu.2018.00646.Pockley A. G., Lindsay J. O., Foulds G. A. et al. Immune Reconstitution After Autologous Hematopoietic Stem Cell Transplantation in Crohn’s Disease: Current Status and Future Directions. A Review on Behalf of the EBMT Autoimmune Diseases Working Party and the Autologous Stem Cell Transplantation In Refractory CD-Low Intensity Therapy Evaluation Study Investigators. FrontImmunol. 2018;9:646. https://doi.org/10.3389/fimmu.2018.00646.Farge D., Pugnet G., Allez M. et al. MATHEC collaborators. National diagnostic and care protocols (NDCP) for hematopoietic stem cell transplantation in autoimmune diseases // Rev Med Interne. 2024. Vol. 42, № 2. Art. S0248-8663(24)00001-8. https://doi.org/10.1016/j.revmed.2023.12.008.Farge D., Pugnet G., Allez M. et al. MATHEC collaborators. National diagnostic and care protocols (NDCP) for hematopoietic stem cell transplantation in autoimmune diseases. Rev Med Interne. 2024;42(2):S0248-8663(24)00001-8. https://doi.org/10.1016/j.revmed.2023.12.008.Ганич Е. Г., Щукина О. Б., Полушин А. Ю. и др. Высокодозная иммуносупрессивная терапия с аутологичной трансплантацией гемопоэтических стволовых клеток при болезни Крона: обзор литературы // Новые Санкт-Петербургские врачебные ведомости. 2024. № 2. С. 11–24. https://doi.org/10.24884/1609-2201-2024-103-2-11-24.Ganich E. G., Shchukina O. B., Polushin A. Yu. et al. High-dose immunosuppressive therapy with autologous hematopoietic stem cell transplantation in Crohn disease: literature review. New St. Petersburg Medical Records. 2024;(2):11–24. (In Russ.) https://doi.org/10.24884/1609-2201-2024103-2-11-24.Lindsay J., Din S., Hawkey C. et al. OFR-9 An RCT of autologous stem-cell transplantation in treatment refractory Crohn’s disease (low-intensity therapy evaluation): ASTICliteGut // Abstracts of the BSG Annual Meeting, 8–12 November 2021. 2021. Vol. 70. P. A4.Lindsay J., Din S., Hawkey C. et al. OFR-9 An RCT of autologous stem-cell transplantation in treatment refractory Crohn’s disease (low-intensity therapy evaluation): ASTICliteGut. Abstracts of the BSG Annual Meeting, 8–12 November 2021. 2021;70:A4.Oyama Y., Craig R. M., Traynor A. E. et al. Autologous hematopoietic stem cell transplantation in patients with refractory Crohn’s disease // Gastroenterology. 2005. Vol. 128, № 3. P. 552–63. https://doi.org/10.1053/j.gastro.2004.11.051.Oyama Y., Craig R. M., Traynor A. E. et al. Autologous hematopoietic stem cell transplantation in patients with refractory Crohn’s disease. Gastroenterology. 2005;128(3):552–63. https://doi.org/10.1053/j.gastro.2004.11.051.Hasselblatt P., Drognitz K., Potthoff K. et al. Remission of refractory Crohn’s disease by high-dose cyclophosphamide and autologous peripheral blood stem cell transplantation // Aliment PharmacolTher. 2012. Vol. 36, № 8. P. 725–35. https://doi.org/10.1111/apt.12032.Hasselblatt P., Drognitz K., Potthoff K. et al. Remission of refractory Crohn’s disease by high-dose cyclophosphamide and autologous peripheral blood stem cell transplantation. Aliment PharmacolTher. 2012;36(8):725–35. https://doi.org/10.1111/apt.12032.Atkins H. L., Bowman M., Allan D. et al. Immunoablation and autologous haemopoietic stem-cell transplantation for aggressive multiple sclerosis: a multicentre single-group phase 2 trial // Lancet. 2016. Vol. 388. P. 576–85. https://doi.org/10.1016/S0140-6736(16)30169-6.Atkins H. L., Bowman M., Allan D. et al. Immunoablation and autologous haemopoietic stem-cell transplantation for aggressive multiple sclerosis: a multicentre single-group phase 2 trial. Lancet. 2016;388:576–85. https://doi.org/10.1016/S01406736(16)30169-6.Nash R. A., Hutton G. J., Racke M. K. et al. High-dose immunosuppressive therapy and autologous hematopoietic cell transplantation for relapsing remitting multiple sclerosis (HALT-MS): A 3-year interim report // JAMA Neurol. 2015. Vol. 72. P. 159–169. https://doi.org/10.1001/jamaneurol.2014.3780.Nash R. A., Hutton G. J., Racke M. K. et al. High-dose immunosuppressive therapy and autologous hematopoietic cell transplantation for relapsing remitting multiple sclerosis (HALT-MS): A 3-year interim report. JAMA Neurol. 2015;72:159–169. https://doi.org/10.1001/jamaneurol.2014.3780.Mancardi G. L., Sormani M. P., Gualandi F. et al. Autologous hematopoietic stem cell transplantation in multiple sclerosis: a phase II trial // Neurology. 2015. Vol. 84. P. 981–988. https://doi.org/10.1212/WNL.0000000000001329.Mancardi G. L., Sormani M. P., Gualandi F. et al. Autologous hematopoietic stem cell transplantation in multiple sclerosis: a phase II trial. Neurology. 2015;84:981–988. https://doi.org/10.1212/WNL.0000000000001329.Burt R. K., Loh Y., Cohen B. et al. Autologous non-myeloablative haemopoietic stem cell transplantation in relapsing-remitting multiple sclerosis: a phase I/II study // Lancet Neurol. 2009. Vol. 8, № 3. P. 244–53. https://doi.org/10.1016/S1474-4422(09)700171. PMID: 19186105.Burt R. K., Loh Y., Cohen B. et al. Autologous non-myeloablative haemopoietic stem cell transplantation in relapsing-remitting multiple sclerosis: a phase I/II study. Lancet Neurol. 2009;8(3):244–53. https://doi.org/10.1016/S1474-4422(09)70017-1. PMID: 19186105.Burt R. K., Balabanov R., Burman J. et al. Effect of nonmyeloablative hematopoietic stem cell transplantation vs continued disease-modifying therapy on disease progression in patients with relapsing-remitting multiple sclerosis // JAMA. 2019. Vol. 321, № 2. P. 165–174. https://doi.org/10.1001/jama.2018.18743Burt R. K., Balabanov R., Burman J. et al. Effect of nonmyeloablative hematopoietic stem cell transplantation vs continued disease-modifying therapy on disease progression in patients with relapsing-remitting multiple sclerosis. JAMA. 2019;321(2):165–174. https://doi.org/10.1001/jama.2018.18743.
The authors declare that there are no conflicts of interest present.