DK2606120T3 - Humane faciliterende celler og anvendelser deraf. - Google Patents

Humane faciliterende celler og anvendelser deraf. Download PDF

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DK2606120T3
DK2606120T3 DK11818739.2T DK11818739T DK2606120T3 DK 2606120 T3 DK2606120 T3 DK 2606120T3 DK 11818739 T DK11818739 T DK 11818739T DK 2606120 T3 DK2606120 T3 DK 2606120T3
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Suzanne Ildstad
Mary Jane Elliott
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Univ Louisville Res Found
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Claims (15)

  1. - 1 -
    1. Terapeutisk cellulær sammensætning, der omfatter: 5 humane hæmatopoietiske stamceller (HSC’er), hvor HSC’eme har fænotypen CD34+; humane faciliterende celler (hFC’er), hvor hFC’eme omfatter celler med fænotypen CD8+ / alfa-beta-TCR- / CD56dim/neg og celler med fænotypen CD8+ / alfa-beta-TCR- / CD56bnght; og humane alfa-beta-TCR+-T-celler; 10 til anvendelse i en fremgangsmåde til at gøre immunsystemet hos en recipient kimerisk med immunsystemet hos en donor, hvilken fremgangsmåde omfatter: administrering af sammensætningen til recipienten, hvor recipienten er blevet konditioneret, hvor konditioneringen er helkropsbestråling, administration af et toksisk eller terapeutisk middel, administration af et monoklonalt antistof eller et monoklonalt 15 antistof, der er bundet til et toksin eller en radioisotop, eller en kombination af hvilke som helst af disse, hvor alfa-beta-TCR+-T-celleme er til stede i en mængde, der er større end, hvad der ville blive betragtet som terapeutisk, hvor antallet af alfa-beta-TCR+-T-celler er justeret til mellem 2,0 x 106 og 5,0 x 106 alfa-beta-TCR+-T-celler pr. kg af recipientens kropsvægt. 20
  2. 2. Sammensætning til anvendelse ifølge krav 1, hvor hFC’eme forbedrer inkorporeringsevnen for HSC’eme sammenlignet med HSC’er, der inkorporeres i fravær af hFC’eme.
  3. 3. Sammensætning til anvendelse ifølge krav 1, hvor konditioneringen af recipienten inkluderer en dosis af helkropsbestråling (TBI), hvor helkropsbestrålingen ikke overstiger 300 cGy.
  4. 4. Sammensætning til anvendelse ifølge krav 1, hvor den terapeutiske cellulære 30 sammensætning administreres til recipienten intravenøst. - 2 -
  5. 5. Sammensætning til anvendelse ifølge krav 1, hvor recipientens immunsystem betragtes som kimerisk med donorens immunsystem, når recipientens immunsystem er mindst 1 % donor-oprindelse.
  6. 6. Sammensætning til anvendelse ifølge krav 1, hvor recipienten har en sygdom, især hvor sygdommen er udvalgt fra gruppen, der består af: autoimmun sygdom, især diabetes, multipel sklerose eller systemisk lupus erythematosus, leukæmi, 10 en hæmoglobinopati, en arvelig metabolisk forstyrrelse, en sygdom, der nødvendiggør en organtransplantation, især hvor organet er hjerte, hud, lever, lunge, hjerte og lunge, nyre, pankreas, eller et endokrint organ, især hvor det endokrine organ er en thyreoideakirtel, parathyreoideakirtel, en thymus, binyrebark eller 15 binyremarv, en infektion af et immundefektvirus eller hepatitis og en hæmatopoietisk malignitet, anæmi, hæmoglobinopatier og en enzymdefekt.
  7. 7. Terapeutisk cellulær sammensætning til administration til en recipient, der omfatter: 20 humane hæmatopoietiske stamceller (HSC’er), hvor HSC’eme har fænotypen CD34+; humane faciliterende celler (hFC’er), hvor hFC’eme omfatter celler med fænotypen CD8+ / alfa-beta-TCR- / CD56dim/neg og celler med fænotypen CD8+ / alfa-beta-TCR- / CD56bnght; og humane alfa-beta-TCR+-T-celler, hvor alfa-beta-TCR+-T-celleme er til stede i en 25 mængde, der er større end, hvad der ville blive betragtet som terapeutisk, hvor antallet af alfa-beta-TCR+-T-celler er justeret til mellem 2,0 x 106 og 5,0 x 106 alfa-beta-TCR+-T-celler pr. kg af recipientens kropsvægt.
  8. 8. Sammensætning til anvendelse ifølge krav 1 eller sammensætning ifølge krav 7, hvor 30 antallet af alfa-beta-TCR+-T-celler er justeret til mellem 3,0 x 106 og 4,2 x 106 alfa- beta-TCR+-T-celler pr. kg af recipientens kropsvægt. - 3 -
  9. 9. Fremgangsmåde til fremstilling af en terapeutisk cellulær sammensætning til administration til en recipient, der omfatter trinene: tilvejebringelse afen donorkilde af humane hæmatopoietiske stamceller (HSC’er); udtømning af humane alfa-beta-TCR+-T-celler fra donorkilden til frembringelse af en 5 udtomt donorkilde; justering af antallet af humane alfa-beta-TCR+-T-celler i den udtømte donorkilde til mellem 2,0 x 106 og 5,0 x 106 humane alfa-beta-TCR+-T-celler pr. kg af recipientens kropsvægt, til derved frembringelse af en terapeutisk cellulær sammensætning til administration til 10 en recipient, hvor fremgangsmåden ikke benytter et humant embryo.
  10. 10. Fremgangsmåde ifølge krav 9, hvor kilden af humane HSC’er er knoglemarv, thymus eller perifert blod. 15
  11. 11. Fremgangsmåde ifølge krav 10, hvor kilden af humane HSC’er er knoglemarv.
  12. 12. Fremgangsmåde ifølge et hvilket som helst af kravene 9 til 11, hvor kilden af humane HSC’er og/eller cellerne er udtomt ved anvendelse af et eller flere antistoffer. 20
  13. 13. Fremgangsmåde ifølge krav 12, hvor det ene eller de flere antistoffer er konjugeret til magnetiske kom.
  14. 14. Fremgangsmåde ifølge krav 9, hvor antallet af alfa-beta-TCR+-T-celler justeres til 25 mellem 3,0 x 106 og 4,2 x 106 alfa-beta-TCR+-T-celler pr. kg af recipientens kropsvægt.
  15. 15. Sammensætning til anvendelse ifølge et hvilket som helst af kravene 1 til 8, der kan fremstilles ved hjælp af fremgangsmåden ifølge et hvilket som helst af kravene 9 til 14. 30
DK11818739.2T 2010-08-17 2011-08-17 Humane faciliterende celler og anvendelser deraf. DK2606120T3 (da)

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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

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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
EP2797421B1 (en) 2011-12-22 2020-05-20 Yeda Research And Development Co. Ltd. A combination therapy for a stable and long term engraftment using specific protocols for t/b cell depletion
US9657290B2 (en) 2012-07-03 2017-05-23 The Board Of Trustees Of The Leland Stanford Junior University Scalable bio-element analysis
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