HRP20170657T1 - Imunomodulatorne ishodišne (imp) stanice - Google Patents

Imunomodulatorne ishodišne (imp) stanice Download PDF

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HRP20170657T1
HRP20170657T1 HRP20170657TT HRP20170657T HRP20170657T1 HR P20170657 T1 HRP20170657 T1 HR P20170657T1 HR P20170657T T HRP20170657T T HR P20170657TT HR P20170657 T HRP20170657 T HR P20170657T HR P20170657 T1 HRP20170657 T1 HR P20170657T1
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cells
population
detectable levels
express detectable
imp
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HRP20170657TT
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Ajan Reginald
Martin John Evans
Sabena SULTAN
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Cell Therapy Limited
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Claims (12)

1. Imunomodulatorna ishodišna (IMP; engl. immuno-modulatory progenitor) stanica, naznačena time, što stanica na svojoj površini izražava uočljive razine MIC A/B, CD304 (neuropilin 1), CD178 (FAS ligand), CD289 (receptor 9 tipa Toll), CD363 (sfingozin-1-fosfat receptor 1), CD99, CD181 (C-X-C kemokin receptor tipa 1; CXCR1), receptor epidermalnog faktora rasta (EGF-R), CXCR2 i CD126.
2. IMP stanica prema zahtjevu 1, naznačena time, što (a) IMP stanica je sposobna migrirati do, prianjati na, razmnožavati se u, ispoljavati protuupalne učinke na i/ili potpomagati angiogenezu u specifičnom, oštećenom tkivu pacijenta; (b) IMP stanica je sposobna migrirati kroz vaskularni endotelij do specifičnog, oštećenog tkiva pacijenta; (c) IMP stanica je sposobna migrirati do, prianjati na, razmnožavati se u, ispoljavati protuupalne učinke na i/ili potpomagati angiogenezu u oštećenom srčanom, koštanom, hrskavičnom, tetivnom, ligamentnom, jetrenom, bubrežnom ili plućnom tkivu pacijenta; ili (d) IMP stanica je sposobna migrirati kroz vaskularni endotelij do oštećenog srčanog, koštanog, hrskavičnog, tetivnog, ligamentnog, jetrenog, bubrežnog ili plućnog tkiva pacijenta.
3. IMP stanica prema zahtjevu 1 ili 2, naznačena time, što (a) IMP stanica je sposobna diferencirati se u mezodermalnu stanicu in vitro; (b) IMP stanica je autologna ili alogeneička; i/ili (c) u IMP stanicu se umeće ili transfektira in vitro ili ex vivo terapijsko i/ili dijagnostičko sredstvo.
4. Populacija od dvije ili više IMP stanica prema bilo kojem od prethodnih zahtjeva.
5. Populacija imunomodulatornih ishodišnih (IMP) stanica, naznačena time, što (i) najmanje 90 % stanica u populaciji na svojoj površini izražava uočljive razine MIC A/B, (ii) najmanje 60 % stanica u populaciji na svojoj površini izražava uočljive razine CD304 (neuropilin 1), (iii) najmanje 45 % stanica u populaciji na svojoj površini izražava uočljive razine CD178 (FAS ligand), (iv) najmanje 10 % stanica u populaciji na svojoj površini izražava uočljive razine CD289 (receptor 9 tipa Toll), (v) najmanje 15 % stanica u populaciji na svojoj površini izražava uočljive razine CD363 (sfingozin-1-fosfat receptor 1), (vi) najmanje 20 % stanica u populaciji na svojoj površini izražava uočljive razine CD99, (vii) najmanje 80 % stanica u populaciji na svojoj površini izražava uočljive razine CD181 (C-X-C kemokin receptor tipa 1; CXCR1), (viii) najmanje 30 % stanica u populaciji na svojoj površini izražava uočljive razine receptora epidermalnog faktora rasta (EGF-R), (xi) najmanje 60 % stanica u populaciji na svojoj površini izražava uočljive razine CXCR2 i (x) najmanje 5 % stanica u populaciji na svojoj površini izražava uočljive razine CD126.
6. Populacija prema zahtjevu 5, naznačena time, što (a) (i) najmanje 97 % stanica u populaciji na svojoj površini izražava uočljive razine MIC A/B, (ii) najmanje 65 % stanica u populaciji na svojoj površini izražava uočljive razine CD304 (neuropilin 1), (iii) najmanje 51 % stanica u populaciji na svojoj površini izražava uočljive razine CD178 (FAS ligand), (iv) najmanje 11 % stanica u populaciji na svojoj površini izražava uočljive razine CD289 (receptor 9 tipa Toll), (v) najmanje 18 % stanica u populaciji na svojoj površini izražava uočljive razine CD363 (sfingozin-1-fosfat receptor 1), (vi) najmanje 24 % stanica u populaciji na svojoj površini izražava uočljive razine CD99, (vii) najmanje 85 % stanica u populaciji na svojoj površini izražava uočljive razine CD181 (CXCR1), (viii) najmanje 33 % stanica u populaciji na svojoj površini izražava uočljive razine receptora epidermalnog faktora rasta (EGF-R), (ix) najmanje 68 % stanica u populaciji na svojoj površini izražava uočljive razine CXCR2 i (x) najmanje 7 % stanica u populaciji na svojoj površini izražava uočljive razine CD126; (b) najmanje 90 % stanica u populaciji na svojoj površini izražava uočljive razine jednog ili više ili svega od sljedećeg: CD10, CD111, CD267, CD47, CD273, CD51/CD61, CD49f, CD49d, CD146, CD55, CD340, CD91, Notch2, CD175s, CD82, CD49b, CD95, CD63, CD245, CD58, CD108, B2-mikroglobulin, CD155, CD298, CD44, CD49c, CD105, CD166, CD230, HLA-ABC, CD13, CD29, CD49e, CD59, CD73, CD81, CD90, CD98, CD147, CD151 i CD276; (c) najmanje 80 % stanica u populaciji na svojoj površini izražava uočljive razine jednog ili više ili svega od sljedećeg: CD156b, CD61, CD202b, CD130, CD148, CD288, CD337, SSEA-4, CD349 i CD140b; (d) najmanje 70 % stanica u populaciji na svojoj površini izražava uočljive razine jednog ili više ili svega od sljedećeg: CD318, CD351, CD286, CD46, CD119 i CD132; (e) 1 % ili manje stanica u populaciji na svojoj površini izražava uočljive razine jednog ili više ili svega od sljedećeg: CD72, CD133, CD192, CD207, CD144, CD41b, FMC7, CD75, CD3e, CD37, CD158a, CD172b, CD282, CD100, CD94, CD39, CD66b, CD158b, CD40, CD35, CD15, PAC-1, CLIP, CD48, CD278, CD5, CD103, CD209, CD3, CD197, HLA-DM, CD20, CD74, CD87, CD129, CDw329, CD57, CD163, TPBG, CD206, CD243 (BD), CD19, CD8, CD52, CD184, CD107b, CD138, CD7, CD50, HLA-DR, CD158e2, CD64, DCIR, CD45, CLA, CD38, CD45RB, CD34, CD101, CD2, CD41a, CD69, CD136, CD62P, TCR alfa beta, CD16b, CD1a, ITGB7, CD154, CD70, CDw218a, CD137, CD43, CD27, CD62L, CD30, CD36, CD150, CD66, CD212, CD177, CD142, CD167, CD352, CD42a, CD336, CD244, CD23, CD45RO, CD229, CD200, CD22, CDH6, CD28, CD18, CD21, CD335, CD131, CD32, CD157, CD165, CD107a, CD1b, CD332, CD180, CD65 i CD24; (f) populacija ima svojstva definirana u zahtjevu 2 ili 3; i/ili (g) populacija sadrži najmanje 5000 stanica, najmanje 50.000 stanica ili najmanje 250.000 stanica.
7. Farmaceutski pripravak koji se sastoji od (a) IMP stanice prema bilo kojem zahtjevu od 1 do 3 ili populacije prema bilo kojem zahtjevu od 4 do 6 i (b) farmaceutski prihvatljivog nosača ili otapala, jednog ili više liposoma i/ili jednog ili više mikromjehurića.
8. Postupak za dobivanje populacije IMP stanica prema bilo kojem zahtjevu od 4 do 6, koji se sastoji od (i) uzgajanja mononuklearnih stanica od 15 do 25 dana u sredstvu koji sadrži lizat trombocita, pri manje od 20 % kisika (O2) i u uvjetima koji omogućavaju IMP stanicama da prianjaju radi izazivanja diferencijacije mononuklearnih stanica u IMP stanice i (ii) sakupljanja i uzgajanja tih IMP stanica koje uzorak ekspresije kako je definirano u zahtjevu 1, čime se dobiva populacija prema bilo kojem zahtjevu od 4 do 6.
9. Postupak prema zahtjevu 8, naznačen time, što: (a) mononuklearne stanice su mononuklearne stanice periferne krvi (PBMC); i/ili (b) mononuklearne stanicu se dobivene od pacijenta ili alogeneičkog davatelja.
10. Populacija prema bilo kojem zahtjevu od 4 do 6 ili farmaceutski pripravak prema zahtjevu 7 za primjenu u postupku reparacije tkiva u pacijenta ili liječenja srčane, koštane, hrskavične, tetivne, ligamentne, jetrene, bubrežne ili plućne ozljede ili bolesti kod pacijenta.
11. Populacija iz zahtjeva 10 za primjenu prema zahtjevu 10, naznačena time, što: (i) oštećeno tkivo se dobiva iz mezoderma; (ii) oštećeno tkivo je srčano, koštano, hrskavično, tetivno, ligamentno, jetreno, bubrežno ili plućno tkivo; i/ili (iii) oštećeno je tkivo oštećeno ozljedom ili bolešću: ili (i) srčana ozljeda ili bolest odabrana je iz infarkta miokarda, hipertrofije lijeve klijetke, hipertrofija desne klijetke, embolije, zatajenja srca, kongenitalnog srčanog deficita, bolesti srčanih zalistaka, aritmije i miokarditisa, i/ili populacija se dobiva iz mononuklearnih stanica pacijenta ili alogeneičkog davatelja; ili (ii) koštana ozljeda ili bolest odabrana je iz frakture, Salter-Harrisove frakture, frakture „zelene grančice“, osteofita, kraniosinostoze, Coffin-Lowryjevog sindroma, Fongove bolesti (ili sindroma nokta-čašice), hipofosfatazije, Klippel-Feilovog sindroma, metaboličke bolesti kostiju, sindroma nokta-čašice, osteoartritisa, osteitis deformansa (ili Pagetovoe bolesti kostiju), fibroznocističnog osteitisa (ili fibroznog osteitisa ili Von Recklinghausenove bolesti kostiju), osteitisa pubis, kondenzacijskog osteitisa (ili osteitisa condensans), osteitisa condensans ilii, osteochondritisa dissecans, osteogenesis imperfecta. osteomalacije, osteomijelitisa, osteopenije, osteopetroze, osteoporoze, osteonekroze, porozne hiperostoze, primarnog hiperparatiroidizma, bubrežne osteodistrofije, raka kostiju, lezije kostiju povezane s metastatskim rakom, Gorham Stoutove bolesti, primarnog hiperparatiroidizma, parodontne bolesti i aseptičnog gubitka zamjene zgloba, i/ili populacija se dobiva iz monunuklearnih stanica pacijenta ili alogeneičkog davatelja.
12. Populacija iz zahtjeva 10 za primjenu prema zahtjevu 10 ili 11, naznačena time, što se populacija dobiva iz mononuklearnih stanica pacijenta ili alogeneičkog davatelja.
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