PL241050B1 - Zastosowanie limfocytów T regulatorowych jako leku w leczeniu stwardnienia rozsianego - Google Patents

Zastosowanie limfocytów T regulatorowych jako leku w leczeniu stwardnienia rozsianego Download PDF

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Publication number
PL241050B1
PL241050B1 PL432200A PL43220019A PL241050B1 PL 241050 B1 PL241050 B1 PL 241050B1 PL 432200 A PL432200 A PL 432200A PL 43220019 A PL43220019 A PL 43220019A PL 241050 B1 PL241050 B1 PL 241050B1
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cells
tregs
regulatory
patients
marek
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PL432200A
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PL432200A1 (pl
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Piotr TRZONKOWSKI
Piotr Trzonkowski
Kamil CHWOJNICKI
Kamil Chwojnicki
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Gdanski Univ Medyczny
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Priority to PL432200A priority Critical patent/PL241050B1/pl
Priority to CN202080086174.8A priority patent/CN114786688B/zh
Priority to KR1020227024028A priority patent/KR20220114047A/ko
Priority to EP20841790.7A priority patent/EP4058034A1/en
Priority to US17/755,016 priority patent/US20220387490A1/en
Priority to PCT/PL2020/000094 priority patent/WO2021118374A1/en
Priority to JP2022534320A priority patent/JP7624683B2/ja
Publication of PL432200A1 publication Critical patent/PL432200A1/pl
Publication of PL241050B1 publication Critical patent/PL241050B1/pl
Priority to US19/407,506 priority patent/US20260083664A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/14—Blood; Artificial blood
    • A61K35/17—Lymphocytes; B-cells; T-cells; Natural killer cells; Interferon-activated or cytokine-activated lymphocytes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K40/00—Cellular immunotherapy
    • A61K40/10—Cellular immunotherapy characterised by the cell type used
    • A61K40/11—T-cells, e.g. tumour infiltrating lymphocytes [TIL] or regulatory T [Treg] cells; Lymphokine-activated killer [LAK] cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K40/00—Cellular immunotherapy
    • A61K40/20—Cellular immunotherapy characterised by the effect or the function of the cells
    • A61K40/22—Immunosuppressive or immunotolerising
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K40/00—Cellular immunotherapy
    • A61K40/40—Cellular immunotherapy characterised by antigens that are targeted or presented by cells of the immune system
    • A61K40/41—Vertebrate antigens
    • A61K40/416—Antigens related to auto-immune diseases; Preparations to induce self-tolerance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/06—Animal cells or tissues; Human cells or tissues
    • C12N5/0602—Vertebrate cells
    • C12N5/0634—Cells from the blood or the immune system
    • C12N5/0636—T lymphocytes
    • C12N5/0637—Immunosuppressive T lymphocytes, e.g. regulatory T cells or Treg
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2121/00—Preparations for use in therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2239/00—Indexing codes associated with cellular immunotherapy of group A61K40/00
    • A61K2239/31—Indexing codes associated with cellular immunotherapy of group A61K40/00 characterized by the route of administration
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2501/00—Active agents used in cell culture processes, e.g. differentation
    • C12N2501/50—Cell markers; Cell surface determinants
    • C12N2501/505—CD4; CD8
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N2501/00—Active agents used in cell culture processes, e.g. differentation
    • C12N2501/50—Cell markers; Cell surface determinants
    • C12N2501/515—CD3, T-cell receptor complex

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
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  • Biomedical Technology (AREA)
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  • Zoology (AREA)
  • Genetics & Genomics (AREA)
  • Wood Science & Technology (AREA)
  • Cell Biology (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
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  • Developmental Biology & Embryology (AREA)
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  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
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Abstract

Przedmiotem wynalazku jest produkt limfocytów Tregs CD3+CD4+CD25+CD127 - do zastosowania jako lek do leczenia stwardnienia rozsianego.

Claims (5)

  1. PL 241 050 Β1
    CCR10+ 87.07 6.4x10' 9 94.97 1.9xl0-9
    CKCR4+ 12.09 0.002 2.78 0.11
    CCR4+ 7.81 0.011 1.10 0.30
    CD103+ 14.45 0.001 5.58 0.027
    CCR8+ 0.97 0.33 0.23 0.63
    CD 18+ 0.004 0.94 0.01 0.89
    CD39+ 48.82 5.1x10 7 12.08 0.002
    CTLA-4+ 34.28 6.8x10' 6 11.97 0.002
    PD-1+ 0.86 0.36 0.00002 0.99
    4-1BB+ 9.71 0.005 0.007 0.93
    ΟΧ40+ 1.62 0.21 0.79 0.38
    Cytokiny
    Badanie obejmowało również analizę 38 różnych cytokin zmierzonych w surowicy pacjentów. Pacjenci leczeni w sposób iv., w porównaniu do tc., ujawnili wyższy poziom cytokin Th2: IL5 i IL13 (test ANOVA, odpowiednio F = 12,05 p = 0,0001 i F = 356,2 p = 0,003) oraz czynników związanych z zapaleniem: IL17, IFNgamma, MCP-3, CXCRL8 i IL1RA (ANOVA F = 30,71 p = 0,031, F = 118,1 p = 0,008, F = 259,1 p = 0,004, F = 17,96 p = 0,049, F = 68,41 p = 0,014). Co ciekawe, także poziom czynnika troficznego mózgu TGFalfa był wyższy w grupie tc. (ANOVA F = 38,21 p = 0,025). Poziom innych zmierzonych cytokin nie różnił się między grupami badanymi oraz w trakcie obserwacji.
    Literatura:
    1. Trzonkowski P, Bieniaszewska M, Juścińska J, Dobyszuk A, Krzystyniak A, Marek N, Myśliwska J, Hellmann A., First-in-man clinical results of the treatment of patients with graft versus host disease with human ex vivo expanded CD4+CD25+CD127- T regulatory cells. Clin Immunol. 133, 22-26 (2009).
  2. 2. Marek-Trzonkowska N, Myśliwiec M, Dobyszuk A, Grabowska M, Techmanska I, Juscinska J, Wujtewicz MA, Witkowski P, Młynarski W, Balcerska A, Myśliwska J, Trzonkowski P., Administration of CD4+CD25highCD127- Regulatory T Cells Preserves β-Cell Function in Type 1 Diabetes in Children. Diabetes Care 35, 1817-1820 (2012).
  3. 3. Marek-Trzonkowska N et a!., Factors affecting long-term efficacy of T regulatory celi- based therapy in type 1 diabetes. Journal ofTranslational Medicine 14, 332 (2016).
  4. 4. Marek-Trzonkowska N et al., Therapy of type 1 diabetes with CD4+CD25highCD127-regulatory T cells prolongs survival of pancreatic islets - Results of one year follow-up. Clinical Immunology 153, 23-30 (2014).
  5. 5. EuroQol - a new facility for the measurement of health-related quality of life. Health Policy 16, 199-208 (1990).
    Zastrzeżenia patentowe
    1. Produkt limfocytów Tregs CD3+CD4+CD25+CD127- do zastosowania jako lek do leczenia stwardnienia rozsianego, przeznaczony do podawania do kanału rdzenia kręgowego.
    2. Produkt według zastrz. 1, znamienny tym, że jest podawany dooponowo.
PL432200A 2019-12-12 2019-12-12 Zastosowanie limfocytów T regulatorowych jako leku w leczeniu stwardnienia rozsianego PL241050B1 (pl)

Priority Applications (8)

Application Number Priority Date Filing Date Title
PL432200A PL241050B1 (pl) 2019-12-12 2019-12-12 Zastosowanie limfocytów T regulatorowych jako leku w leczeniu stwardnienia rozsianego
CN202080086174.8A CN114786688B (zh) 2019-12-12 2020-12-11 治疗多发性硬化症中鞘内施用调节性t细胞
KR1020227024028A KR20220114047A (ko) 2019-12-12 2020-12-11 다발성 경화증의 치료에서 t 조절 세포의 수막강내 투여
EP20841790.7A EP4058034A1 (en) 2019-12-12 2020-12-11 Intrathecal administration of t regulatory cells in the treatment of multiple sclerosis
US17/755,016 US20220387490A1 (en) 2019-12-12 2020-12-11 Intrathecal administration of t regulatory cells in the treatment of multiple sclerosis
PCT/PL2020/000094 WO2021118374A1 (en) 2019-12-12 2020-12-11 Intrathecal administration of t regulatory cells in the treatment of multiple sclerosis
JP2022534320A JP7624683B2 (ja) 2019-12-12 2020-12-11 多発性硬化症の治療における制御性ｔ細胞の髄腔内投与
US19/407,506 US20260083664A1 (en) 2019-12-12 2025-12-03 Intrathecal administration of t regulatory cells in the treatment of multiple sclerosis

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PL432200A PL241050B1 (pl) 2019-12-12 2019-12-12 Zastosowanie limfocytów T regulatorowych jako leku w leczeniu stwardnienia rozsianego

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PL432200A1 PL432200A1 (pl) 2021-06-14
PL241050B1 true PL241050B1 (pl) 2022-07-25

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EP (1) EP4058034A1 (pl)
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KR (1) KR20220114047A (pl)
CN (1) CN114786688B (pl)
PL (1) PL241050B1 (pl)
WO (1) WO2021118374A1 (pl)

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KR102596140B1 (ko) * 2021-09-13 2023-11-01 주식회사 브이티바이오 조절 t 세포를 유효성분으로 포함하는 퇴행성 뇌질환 예방 또는 치료용 약학적 조성물

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AU2005204338A1 (en) * 2005-03-02 2006-09-21 Sydney West Area Health Service Treatment for multiple sclerosis
EP2364163B1 (en) * 2008-07-18 2016-03-16 SentoClone International AB Composition comprising in vitro expanded t-lymphocytes and vessel formation inhibitors suitable in the treatment of cancer
CN102755633B (zh) * 2011-04-28 2014-08-27 北京大学 人重组蛋白pdcd5在治疗自身免疫病中的应用
PL218400B1 (pl) * 2012-06-06 2014-11-28 Gdański Univ Medyczny Szczepionka do leczenia cukrzycy typu 1 u dzieci, zastosowanie sortera komórek oraz sposób namnażania komórek Treg in vitro do wytwarzania szczepionki do leczenia cukrzycy typu 1
RU2523058C2 (ru) * 2012-06-29 2014-07-20 Общество с ограниченной ответственностью "Регенекс" Способ терапии ремиттирующего рассеянного склероза
US20170038394A1 (en) * 2014-04-16 2017-02-09 Genovie Ab Method for the identification of cd4+ regulatory t-cells for use in the treatment of inflammatory and autoimmune diseases
US20170199186A1 (en) * 2014-06-06 2017-07-13 Singapore Health Services Pte Ltd. Methods of using cells associated with autoimmune disease
KR102769850B1 (ko) * 2015-07-03 2025-02-20 인스티튜트 내셔날 드 라 싼테 에 드 라 리셰르셰 메디칼르 조절 t 세포를 수득하는 방법 및 이의 용도
PL236046B1 (pl) * 2015-12-17 2020-11-30 Gdanski Univ Medyczny Sposób namnażania in vitro limfocytów T regulatorowych CD4+ FoxP3+
WO2018024895A1 (en) * 2016-08-05 2018-02-08 INSERM (Institut National de la Santé et de la Recherche Médicale) Immunotherapeutic uses of ex vivo generated foxp3+ regulatory t cells
US12227756B2 (en) * 2018-04-18 2025-02-18 Ucl Business Ltd Engineered regulatory T cell

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CN114786688B (zh) 2024-10-01
EP4058034A1 (en) 2022-09-21
JP2023505785A (ja) 2023-02-13
CN114786688A (zh) 2022-07-22
KR20220114047A (ko) 2022-08-17
US20220387490A1 (en) 2022-12-08
WO2021118374A1 (en) 2021-06-17
US20260083664A1 (en) 2026-03-26
JP7624683B2 (ja) 2025-01-31
PL432200A1 (pl) 2021-06-14

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