RU2019131719A - Макроинкапсулированные терапевтические клетки и способы их применения - Google Patents

Макроинкапсулированные терапевтические клетки и способы их применения Download PDF

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RU2019131719A
RU2019131719A RU2019131719A RU2019131719A RU2019131719A RU 2019131719 A RU2019131719 A RU 2019131719A RU 2019131719 A RU2019131719 A RU 2019131719A RU 2019131719 A RU2019131719 A RU 2019131719A RU 2019131719 A RU2019131719 A RU 2019131719A
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barrier
macrocapsule
glucomannan
sulfate
composition according
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RU2019131719A
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Уильям Л. РАСТ
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Сераксис, Инк.
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/37Digestive system
    • A61K35/39Pancreas; Islets of Langerhans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/4816Wall or shell material
    • A61K9/4825Proteins, e.g. gelatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5036Polysaccharides, e.g. gums, alginate; Cyclodextrin
    • A61K9/5042Cellulose; Cellulose derivatives, e.g. phthalate or acetate succinate esters of hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5052Proteins, e.g. albumin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14Macromolecular materials
    • A61L27/20Polysaccharides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/3683Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment
    • A61L27/3687Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix subjected to a specific treatment prior to implantation, e.g. decellularising, demineralising, grinding, cellular disruption/non-collagenous protein removal, anti-calcification, crosslinking, supercritical fluid extraction, enzyme treatment characterised by the use of chemical agents in the treatment, e.g. specific enzymes, detergents, capping agents, crosslinkers, anticalcification agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/36Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix
    • A61L27/38Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells
    • A61L27/3804Materials for grafts or prostheses or for coating grafts or prostheses containing ingredients of undetermined constitution or reaction products thereof, e.g. transplant tissue, natural bone, extracellular matrix containing added animal cells characterised by specific cells or progenitors thereof, e.g. fibroblasts, connective tissue cells, kidney cells
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/48Drugs for disorders of the endocrine system of the pancreatic hormones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/48Drugs for disorders of the endocrine system of the pancreatic hormones
    • A61P5/50Drugs for disorders of the endocrine system of the pancreatic hormones for increasing or potentiating the activity of insulin
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L1/00Compositions of cellulose, modified cellulose or cellulose derivatives
    • CCHEMISTRY; METALLURGY
    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08LCOMPOSITIONS OF MACROMOLECULAR COMPOUNDS
    • C08L5/00Compositions of polysaccharides or of their derivatives not provided for in groups C08L1/00 or C08L3/00
    • C08L5/04Alginic acid; Derivatives thereof
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N5/00Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/0012Cell encapsulation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K2035/124Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells the cells being hematopoietic, bone marrow derived or blood cells
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K2035/126Immunoprotecting barriers, e.g. jackets, diffusion chambers
    • A61K2035/128Immunoprotecting barriers, e.g. jackets, diffusion chambers capsules, e.g. microcapsules

Claims (23)

1. Композиция, содержащая цилиндрическую макрокапсулу, вмещающую множество инсулин-продуцирующих клеток, причем указанная макрокапсула содержит по меньшей мере один барьер, содержащий:
(a) сульфат целлюлозы и глюкоманнан или сульфат глюкоманнана; или
(b) альгинат натрия;
и второй барьер, не содержащий глюкоманнан или сульфат глюкоманнана; где цилиндрическая макрокапсула имеет диаметр по меньшей мере 1,5 мм.
2. Композиция по п. 1, где макрокапсула имеет длину по меньшей мере приблизительно 11 см.
3. Композиция по п. 1 или 2, где макрокапсула содержит по меньшей мере приблизительно 50000 клеток на см.
4. Композиция, содержащая цилиндрическую макрокапсулу, вмещающую множество инсулин-продуцирующих клеток, где макрокапсула содержит по меньшей мере первый барьер и второй барьер, где первый барьер заключен во втором барьере, и где макрокапсула имеет диаметр по меньшей мере 1,5 мм.
5. Композиция по п. 4, где диаметр макрокапсулы составляет по меньшей мере 2,0 мм.
6. Композиция по п. 4 или 5, где второй барьер содержит сульфат целлюлозы и глюкоманнан или сульфат глюкоманнана.
7. Композиция по любому из пп. 4-6, где как первый, так и второй барьер содержат сульфат целлюлозы и сульфат глюкоманнана.
8. Композиция по п. 4 или 5, где второй барьер не содержит глюкоманнан или сульфат глюкоманнана.
9. Композиция по любому из пп. 4-6, где первый барьер содержит альгинат натрия.
10. Композиция по любому из пп. 4-9, где макрокапсула имеет длину по меньшей мере приблизительно 11 см.
11. Композиция по любому из пп. 4-10, где макрокапсула содержит по меньшей мере приблизительно 50000 клеток на см.
12. Композиция, содержащая макрокапсулу, вмещающую множество терапевтических клеток, где макрокапсула имеет цилиндрическую форму и диаметр по меньшей мере 1,5 мм, причем макрокапсула содержит по меньшей мере первый барьер и второй барьер, где первый барьер заключен во второй барьер, где первый барьер содержит:
(a) сульфат целлюлозы и глюкоманнан или сульфат глюкоманнана; или
(b) альгинат натрия,
и где второй барьер необязательно содержит сульфат целлюлозы и глюкоманнан или сульфат глюкоманнана; или второй барьер не содержит сульфат целлюлозы и глюкоманнан или сульфат глюкоманнана.
13. Композиция по п. 12, где макрокапсула содержит по меньшей мере приблизительно 50000 клеток на см.
14. Способ лечения диабета у нуждающегося в этом субъекта, включающий имплантацию субъекту, страдающему диабетом, композиции по любому из пп. 1-13.
15. Способ по п. 14,
(a) где субъект является взрослым; или где субъект является ребенком; и/или
(b) где субъект страдает диабетом I типа; или где субъект страдает диабетом II типа.
RU2019131719A 2017-04-06 2018-03-01 Макроинкапсулированные терапевтические клетки и способы их применения RU2019131719A (ru)

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US201762482413P 2017-04-06 2017-04-06
US62/482,413 2017-04-06
PCT/US2018/020446 WO2018186953A1 (en) 2017-04-06 2018-03-01 Macro-encapsulated therapeutic cells and methods of using the same

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US (1) US20180289746A1 (ru)
EP (1) EP3606613A1 (ru)
JP (1) JP7293126B2 (ru)
KR (1) KR102572188B1 (ru)
CN (1) CN110709137A (ru)
AU (1) AU2018250008A1 (ru)
BR (1) BR112019020611A2 (ru)
CA (1) CA3058369A1 (ru)
IL (1) IL269817B1 (ru)
RU (1) RU2019131719A (ru)
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WO2019169089A1 (en) * 2018-03-01 2019-09-06 Seraxis, Inc. Macro-encapsulated therapeutic cells, devices, and methods of using the same

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KR101373518B1 (ko) * 2011-04-28 2014-03-13 서울대학교산학협력단 췌도 캡슐 및 이의 제조 방법
JP6538042B2 (ja) * 2013-11-07 2019-07-03 ザ ジェネラル ホスピタル コーポレイション 溶出マトリックスおよびその使用
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JP2018521717A (ja) * 2015-05-17 2018-08-09 マサチューセッツ インスティテュート オブ テクノロジー 細胞および細胞凝集体を封入するための多層ヒドロゲルカプセル

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AU2018250008A1 (en) 2019-10-31
US20180289746A1 (en) 2018-10-11
JP7293126B2 (ja) 2023-06-19
IL269817B1 (en) 2024-03-01
BR112019020611A2 (pt) 2020-04-22
KR102572188B1 (ko) 2023-08-30
CN110709137A (zh) 2020-01-17
KR20190133708A (ko) 2019-12-03
JP2020512999A (ja) 2020-04-30
WO2018186953A1 (en) 2018-10-11
IL269817A (en) 2019-11-28
EP3606613A1 (en) 2020-02-12
SG11201909206XA (en) 2019-11-28
CA3058369A1 (en) 2018-10-11

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