HRP20160102T1 - Humane facilitacijske stanice i njihova uporaba - Google Patents

Humane facilitacijske stanice i njihova uporaba Download PDF

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HRP20160102T1
HRP20160102T1 HRP20160102TT HRP20160102T HRP20160102T1 HR P20160102 T1 HRP20160102 T1 HR P20160102T1 HR P20160102T T HRP20160102T T HR P20160102TT HR P20160102 T HRP20160102 T HR P20160102T HR P20160102 T1 HRP20160102 T1 HR P20160102T1
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cells
alpha beta
recipient
beta tcr
human
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HRP20160102TT
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Suzanne Ildstad
Mary Jane Elliott
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University Of Louisville Research Foundation, Inc.
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Claims (15)

1. Terapeutski stanični pripravak koji obuhvaća: humane krvotvorne matične stanice (HKMS, engl. HSCs), gdje navedene HKMS imaju fenotip CD34+; humane facilitacijske stanice (hFS, engl. hFCs), gdje navedene hFS-e obuhvaćaju stanice koje imaju fenotip CD8+ / alfa beta TCR-/CD56dim/neg i stanice koje imaju fenotip CD8+ / alfa beta TCR-/CD56bright; i humane alfa beta TCR+ T stanice za uporabu u metodi pripravljanja imunog sustava primatelja himernim s imunim sustavom donora, gdje metoda obuhvaća: davanje pripravka primatelju, pri čemu je primatelj kondicioniran gdje je navedeno kondicioniranje ukupno zračenje tijela, davanje toksičnog ili terapeutskog agensa, davanje monoklonskog protutijela ili monoklonskog protutijela vezanog na toksin ili radio izotop ili kombinacija bilo kojeg od njih, gdje su navedene alfa beta TCR+ T stanice prisutne u količini koja je veća od one koja bi se smatrala terapijskom, pri čemu je broj alfa beta TCR+ T stanica podešen na između 2.0 x 106 i 5.0 x 106 alfa beta TCR+ T stanica / kg tjelesne težine primatelja.
2. Pripravak za uporabu prema zahtjevu 1, naznačen time da hFS-e poboljšavaju sposobnost ugradnje navedenih HKMS-a u usporedbi s HKMS-a ugrađenim u odsutnosti navedenih hFS-a.
3. Pripravak za uporabu prema zahtjevu 1, naznačen time da kondicioniranje primatelja uključuje dozu ukupnog tjelesnog zračenja (UTZ, engl. TBI), pri čemu ukupno tjelesno zračenje ne premašuje 300 cGy.
4. Pripravak za uporabu prema zahtjevu 1, naznačen time da se terapeutski stanični pripravak daje intravenski.
5. Pripravak za uporabu prema zahtjevu 1, naznačen time da se imuni sustav primatelja smatra himernim s imunim sustavom donora kada je imuni sustav primatelja najmanje 1% donorovog podrijetla.
6. Pripravak za uporabu prema zahtjevu 1, naznačen time da primatelj ima bolest, osobito gdje je bolest izabrana iz skupine koju čine: autoimune bolesti, osobito dijabetes, multiple skleroza, ili sistemski eritemski lupus, leukemija, hemoglobinopatija, naslijeđeni poremećaj metabolizma, bolest koja zahtijeva transplantaciju organa, osobito gdje je organ srce, koža, jetra, pluća, srce i pluća, bubreg, gušterača, ili endokrini organ, osobito gdje je endokrini organ štitnjača, paratiroidna žlijezda, timus, kora ili srž nadbubrežne žlijezde, infekcija imunodeficijentnim virusom ili hepatitisom, i hematopoetska malignost, anemija, hemoglobinopatija, i nedostatak enzima.
7. Terapeutski stanični pripravak za davanje primatelju, koji obuhvaća: humane krvotvorne matične stanice (HKMS, engl. HSCs), gdje navedene HKMS imaju fenotip CD34+; humane facilitacijske stanice (hFS, engl. hFCs), gdje navedene hFS-ce obuhvaćaju stanice koje imaju fenotip CD8+ / alfa beta TCR-/CD56dim/neg i stanice koje imaju fenotip CD8+ / alfa beta TCR-/CD56bright; i humane alfa beta TCR+ T stanice, gdje su navedene alfa beta TCR+ T stanice prisutne u količini koja je veća od one koja bi se smatrala terapijskom, pri čemu je broj alfa beta TCR+ T stanica podešen na između 2.0 x 106 i 5.0 x 106 alfa beta TCR+ T stanica / kg tjelesne težine primatelja.
8. Pripravak za uporabu prema zahtjevu 1 ili pripravak prema zahtjevu 7, naznačen time da je broj alfa beta TCR+ T stanica podešen na između 3.0 x 106 i 4.2 x 106 alfa beta TCR+ T stanica / kg tjelesne težine primatelja.
9. Postupak priprave terapeutskog staničnog pripravka za primjenu na primatelju koji obuhvaća korake: osiguravanje donorskog izvora humanih krvotvornih matičnih stanica (HKMS, engl. HSCs); crpljenje humanih alfa beta TCR+ T stanica iz navedenog donorskog izvora kako bi se proizveo iscrpljeni donorski izvor; podešavanje broja humanih alfa beta TCR+ T stanica u navedenom iscrpljenom donorskom izvoru na između 2.0 x 106 i 5.0 x 106 humanih alfa beta TCR+ T stanica po kg tjelesne težine primatelja, čime se dobiva terapeutski stanični pripravak za primjenu na primatelju, naznačen time da se u postupku ne koristi humani zametak.
10. Postupak prema zahtjevu 9, naznačen time da je navedeni izvor humanih krvotvornih matičnih stanica (HKMS) koštana srž, timus, ili periferna krv.
11. Postupak prema zahtjevu 10, naznačen time da je navedeni izvor humanih HKMS koštana srž.
12. Postupak prema bilo kojem od zahtjeva 9 do 11, naznačen time da je navedeni izvor humanih HKMS i/ili gdje su stanice crpljene uporabom jednog ili više protutijela.
13. Postupak prema zahtjevu 12, naznačen time da je jedno ili više protutijela konjugirano na magnetsku kuglicu.
14. Postupak prema zahtjevu 9, naznačen time da je broj alfa beta TCR+ T stanica podešen na između 3.0 x 106 i 4.2 x 106 alfa beta TCR+ T stanica / kg tjelesne težine primatelja.
15. Pripravak za uporabu prema bilo kojem od zahtjeva 1 do 8 koji se može izvesti postupkom prema bilo kojem od zahtjeva 9 do 14.
HRP20160102TT 2010-08-17 2016-01-28 Humane facilitacijske stanice i njihova uporaba HRP20160102T1 (hr)

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Application Number Priority Date Filing Date Title
US37446010P 2010-08-17 2010-08-17
US12/957,011 US8632768B2 (en) 2008-05-30 2010-11-30 Human facilitating cells
PCT/US2011/048120 WO2012024427A2 (en) 2010-08-17 2011-08-17 Human facilitating cells and uses thereof
EP11818739.2A EP2606120B1 (en) 2010-08-17 2011-08-17 Human facilitating cells and uses thereof

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US (3) US8632768B2 (hr)
EP (2) EP3037522A1 (hr)
JP (2) JP5980783B2 (hr)
CN (2) CN103328627B (hr)
AU (1) AU2011292011B2 (hr)
CA (1) CA2807701C (hr)
DK (1) DK2606120T3 (hr)
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WO2008097926A2 (en) * 2007-02-02 2008-08-14 Yale University Transient transfection with rna
US11291686B2 (en) 2008-05-30 2022-04-05 University Of Louisville Research Foundation, Inc. Human facilitating cells
US8632768B2 (en) 2008-05-30 2014-01-21 University Of Louisville Research Foundation, Inc. Human facilitating cells
KR101551555B1 (ko) * 2011-03-17 2015-09-08 밀테니 비오텍 게앰베하 Tcr 알파/베타가 고갈된 세포 제제
EP2748307A4 (en) 2011-09-23 2015-08-19 Univ Louisville Res Found METHODS AND COMPOSITIONS FOR CELL EXPANSION AND GRAFT ENHANCEMENT
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