HRP20230474T1 - Postupci za dobivanje stanica izvedenih iz mišića - Google Patents

Postupci za dobivanje stanica izvedenih iz mišića Download PDF

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HRP20230474T1
HRP20230474T1 HRP20230474TT HRP20230474T HRP20230474T1 HR P20230474 T1 HRP20230474 T1 HR P20230474T1 HR P20230474T T HRP20230474T T HR P20230474TT HR P20230474 T HRP20230474 T HR P20230474T HR P20230474 T1 HRP20230474 T1 HR P20230474T1
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smdc
cell population
sample
treatment
range
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HRP20230474TT
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Marco THURNER
Eva MARGREITER
Wolfgang Schwaiger
Faheem Muhammad ASIM
Rainer Marksteiner
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Innovacell Ag
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Publication of HRP20230474T1 publication Critical patent/HRP20230474T1/hr

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    • 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
    • A61K35/34Muscles; Smooth muscle cells; Heart; Cardiac stem cells; Myoblasts; Myocytes; Cardiomyocytes
    • 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
    • C12N5/06Animal cells or tissues; Human cells or tissues
    • C12N5/0602Vertebrate cells
    • C12N5/0652Cells of skeletal and connective tissues; Mesenchyme
    • C12N5/0658Skeletal muscle cells, e.g. myocytes, myotubes, myoblasts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P21/00Drugs for disorders of the muscular or neuromuscular system
    • 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
    • C12N2501/00Active agents used in cell culture processes, e.g. differentation
    • C12N2501/50Cell markers; Cell surface determinants
    • C12N2501/599Cell markers; Cell surface determinants with CD designations not provided for elsewhere
    • 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
    • C12N2501/00Active agents used in cell culture processes, e.g. differentation
    • C12N2501/70Enzymes
    • C12N2501/71Oxidoreductases (EC 1.)
    • 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
    • C12N2509/00Methods for the dissociation of cells, e.g. specific use of enzymes
    • 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
    • C12N2509/00Methods for the dissociation of cells, e.g. specific use of enzymes
    • C12N2509/10Mechanical dissociation

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
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  • Chemical & Material Sciences (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
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  • Compounds Of Unknown Constitution (AREA)

Claims (15)

1. Postupak za dobivanje stanica izvedenih iz skeletnog mišića (SMDC), postupak obuhvaća sljedeće korake: (a) hlađenje uzorka dobivenog iz tkiva skeletnog mišića u puferu; (b) obrada uzorka i hlađenje obrađenog uzorka, pri čemu se hlađenje izvodi na temperaturi u opsegu od 1 do 16°C tokom vremena u opsegu od 2 do 48 sati; (c) resuspendiranje uzorka iz koraka (b) u mediju sa serumom koji sadrži najmanje jedan enzim i zagrijavanje do 25-38°C tokom 1 do 20 sati; peletiranje uzorka i (d) resuspendiranje peleta uzorka iz koraka (c) da bi se osigurala suspenzija pojedinačnih stanica iz uzorka iz koraka (c), čime se dobivaju SMDC.
2. Postupak prema patentnom zahtjevu 1, pri čemu se korak (a) izvodi na temperaturi nižoj od 16°C, poželjno na temperaturi u opsegu od 1 do 16°C, poželjno 4 do 10°C, posebno poželjno na 7°C; i tokom vremena u opsegu do 96 sati.
3. Postupak prema patentnom zahtjevu 1 ili 2, pri čemu korak (b) obuhvaća upotrebu škara, skalpela, pinceta, filtera, ili mlina sa kuglicama.
4. Postupak prema bilo kojem od patentnih zahtjeva 1 do 3, pri čemu se hlađenje u koraku (b) izvodi na temperaturi u opsegu od 4 do 8°C, posebno poželjno 4 °C i tokom vremena u opsegu od 2 sata do 48 sati.
5. Postupak prema bilo kojem od patentnih zahtjeva 1 do 4, pri čemu korak (c) obuhvaća izvođenje enzimskog tretiranja otopinom koja sadrži bilo koji ili više odabranih iz grupe koju čine tripsin, papain, elastaza, hijaluronidaza, kolagenaza, deoksiribonukleaza, i DNK-aza.
6. Postupak prema bilo kojem od patentnih zahtjeva 1 do 5, pri čemu se korak (c) izvodi na temperaturi u opsegu od 36 do 38°C, posebno poželjno na 37°C.
7. Postupak prema bio kojem od patentnih zahtjeva 1 do 6, pri čemu korak (d) poželjno obuhvaća postupak izabran od najmanje jednog FACS sortiranja, centrifugiranja, elektrokinetičkog sortiranja, sortiranja akustoforezom, sortiranja stanica pomoću kuglica i optičkog sortiranja.
8. Postupak prema bilo kojem od patentnih zahtjeva 1 do 7, pri čemu se dalji korak (e) izvodi nakon koraka (d) koji uključe inkubaciju suspenzije pojedinačne stanice dobivene u koraku (d), pri čemu se inkubacija u koraku (e) poželjno izvodi na temperaturi u opsegu od 25 do 38°C, poželjno 36 do 38°C, posebno poželjno na 37°C, čime se dobivaju adherentne SMDC, i nakon koraka (e) po izboru se izvodi dalji korak (f) koji obuhvaća odbacivanje neadherentnih stanica iz koraka (e), pri čemu se korak (f) poželjno izvodi nakon najmanje 6 sati do 4 dana, i nakon koraka (f) po izboru se izvodi dalji korak (g) razmnožavanja adherentnih stanica iz koraka (e), razmnožavanje u koraku (h) obuhvaća uzgoj u kulturi adherentnih stanica za 1 do 5 prolaza do 70 do 80% konfluencije.
9. Stanična populacija SMDC, pri čemu populacija sadrži najmanje 90% CD56 pozitivnih, 90% A2B5 pozitivnih, 90% CD105 pozitivnih i 90% desmin pozitivnih stanica i manje od 10% populacije eksprimira CD34, Sca-1 i MyoD.
10. Stanična populacija SMDC prema patentnom zahtjevu 9 dobivena postupkom prema bilo kojem od patentnih zahtjeva 1 do 8.
11. Stanična populacija SMDC prema patentnom zahtjevu 9 ili 10 za primjenu kao farmaceutska kompozicija.
12. Stanične populacije SMDC prema patentnom zahtjevu 9 ili 10 za primjenu u postupku prevencije i/ili liječenja neuromiopatija i/ili miopatija, poželjno za primjenu u postupku prevencije i/ili liječenja neuromiopatija i/ili miopatija kao što je fekalna inkontinencija i/ili urinarna inkontinencija.
13. Stanična populacija SMDC prema patentnom zahtjevu 9 ili 10 za primjenu u postupku liječenja mišićne disfunkcije, pri čemu je mišićna disfunkcija inkontinencija, posebno urinarna i/ili analna ili fekalna inkontinencija.
14. Stanična populacija SMDC za primjenu prema patentnim zahtjevima 12 ili 13, pri čemu je stanična populacija prema patentnom zahtjevu 9 ili 10 za primjenu u postupku liječenja urinarne inkontinencije a stanična populacija SMDC je osigurana u 50 do 200 µl injekcijske otopine stanične suspenzije sa koncentracijom od 1 × 105 do 6 × 106 stanica na 100 µl injekcijske otopine za injektiranje u urinarni sfinkter.
15. Stanična populacija SMDC za primjenu prema patentnim zahtjevima 12 ili 13, pri čemu je stanična populacija prema patentnom zahtjevu 9 ili 10 za primjenu u postupku liječenja analne inkontinencije i stanična populacija SMDC je osigurana u 50 µl do 1 ml injekcijske otopine stanične suspenzije sa koncentracijom od 1 × 105 to 6 × 106 stanica na 100 µl injekcijske otopine za injektiranje u vanjski analni sfinkter, posebno gdje postupak liječenja analne inkontinencije obuhvaća 20 do 40 injekcija suspenzije stanica izvedenih iz skeletnih mišića, pri čemu se pri svakoj injekciji ubrizgava 50 do 500 µl suspenzije stanice izvedene iz skeletnih mišića i pri čemu se svaka injekcija primjenjuje na drugu regiju analnog sfinktera.
HRP20230474TT 2017-12-14 2018-12-14 Postupci za dobivanje stanica izvedenih iz mišića HRP20230474T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP17207417 2017-12-14
EP18815731.7A EP3724319B1 (en) 2017-12-14 2018-12-14 Methods for obtaining muscle derived cells
PCT/EP2018/085015 WO2019115790A1 (en) 2017-12-14 2018-12-14 Methods for obtaining muscle derived cells

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HRP20230474T1 true HRP20230474T1 (hr) 2023-07-21

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US (2) US11617768B2 (hr)
EP (2) EP4223872A3 (hr)
JP (2) JP7361398B2 (hr)
KR (1) KR20200099173A (hr)
CN (1) CN111448307A (hr)
AU (1) AU2018383015A1 (hr)
BR (1) BR112020011853A2 (hr)
CA (1) CA3085483A1 (hr)
CL (1) CL2020001480A1 (hr)
CY (1) CY1126049T1 (hr)
DK (1) DK3724319T3 (hr)
ES (1) ES2948712T3 (hr)
FI (1) FI3724319T3 (hr)
HR (1) HRP20230474T1 (hr)
HU (1) HUE062005T2 (hr)
IL (2) IL309687A (hr)
LT (1) LT3724319T (hr)
MX (1) MX2020005881A (hr)
PL (1) PL3724319T3 (hr)
PT (1) PT3724319T (hr)
RS (1) RS64241B1 (hr)
SI (1) SI3724319T1 (hr)
WO (1) WO2019115790A1 (hr)
ZA (1) ZA202002410B (hr)

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WO2021065989A1 (ja) * 2019-09-30 2021-04-08 テルモ株式会社 Cd56陽性細胞の比率を高めるための方法
EP4380583A1 (en) 2021-08-06 2024-06-12 Innovacell GmbH Myogenic progenitor cells for use in an optimized method for the prevention and treatment of anal incontinence
WO2024115761A1 (en) 2022-12-01 2024-06-06 Universität Zürich Method of preparing a mass culture of muscle precursor cells (mpcs) and uses thereof
WO2024122705A1 (ko) * 2022-12-08 2024-06-13 주식회사 팡세 근육줄기세포의 분화능 예측을 위한 cd56의 용도

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US5130141A (en) 1988-05-24 1992-07-14 Law Peter K Compositions for and methods of treating muscle degeneration and weakness
US5538722A (en) 1989-06-13 1996-07-23 Stanford University Isolation, growth, differentiation and genetic engineering of human muscle cells
PT1272204E (pt) 2000-04-14 2007-10-02 Univ Pittsburgh Aumento e enchimento de tecidos moles e osso utilizando células progenitoras derivadas de músculo, suas composições e tratamentos
JPWO2003027281A1 (ja) 2001-09-20 2005-01-06 協和醗酵工業株式会社 骨格筋間質由来多分化能幹細胞
EP1617852B1 (en) * 2003-04-25 2010-09-29 The University of Pittsburgh Muscle derived cells (mdcs) for promoting and enhancing nerve repair and regeneration
FR2890977A1 (fr) * 2005-09-19 2007-03-23 Assist Publ Hopitaux De Paris Procede d'obtention de cellules musculaires lisses humaines et leurs applications
WO2007106200A2 (en) * 2006-01-10 2007-09-20 Theradigm, Inc. Expansion and differentiation of neural stem cells under low oxygen conditions
AU2008263134B2 (en) * 2007-05-29 2014-06-19 University Of Pittsburgh-Of The Commonwealth System Of Higher Education Bone augmentation utilizing muscle-derived progenitor compositions, and treatments thereof
EP2206774A1 (en) 2008-12-23 2010-07-14 Genzyme Corporation Muscle-derived cells having differentiation capacities
CN106350480B (zh) * 2016-08-26 2019-11-08 中国农业科学院北京畜牧兽医研究所 一种纯化牛胎儿骨骼肌组织来源成肌细胞的方法
EP3942020B1 (en) 2019-03-22 2024-05-15 Innovacell GmbH Methods for obtaining induced smooth muscle cells

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EP4223872A3 (en) 2023-08-23
US20210069255A1 (en) 2021-03-11
MX2020005881A (es) 2020-08-13
CY1126049T1 (el) 2023-11-15
CA3085483A1 (en) 2019-06-20
IL309687A (en) 2024-02-01
RU2020120580A (ru) 2022-01-14
IL275288A (en) 2020-07-30
EP4223872A2 (en) 2023-08-09
BR112020011853A2 (pt) 2020-11-24
PL3724319T3 (pl) 2023-07-24
JP2023085507A (ja) 2023-06-20
EP3724319B1 (en) 2023-04-05
FI3724319T3 (fi) 2023-05-04
PT3724319T (pt) 2023-06-07
ES2948712T3 (es) 2023-09-18
RS64241B1 (sr) 2023-06-30
WO2019115790A1 (en) 2019-06-20
DK3724319T3 (da) 2023-05-01
JP2021506285A (ja) 2021-02-22
KR20200099173A (ko) 2020-08-21
ZA202002410B (en) 2021-09-29
CN111448307A (zh) 2020-07-24
HUE062005T2 (hu) 2023-09-28
CL2020001480A1 (es) 2020-10-30
LT3724319T (lt) 2023-06-12
SI3724319T1 (sl) 2023-07-31
JP7494430B2 (ja) 2024-06-04
US11617768B2 (en) 2023-04-04
EP3724319A1 (en) 2020-10-21
US20230285467A1 (en) 2023-09-14
AU2018383015A1 (en) 2020-05-28
JP7361398B2 (ja) 2023-10-16

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