DK2984163T3 - Immunmodulatorisk progenitor- (imp) celle - Google Patents

Immunmodulatorisk progenitor- (imp) celle Download PDF

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DK2984163T3
DK2984163T3 DK15729886.0T DK15729886T DK2984163T3 DK 2984163 T3 DK2984163 T3 DK 2984163T3 DK 15729886 T DK15729886 T DK 15729886T DK 2984163 T3 DK2984163 T3 DK 2984163T3
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cells
population
imp
detectable levels
cell
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Ajan Reginald
Martin John Evans
Sabena Sultan
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Cell Therapy Ltd
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Claims (12)

1. Immunmodulatorisk progenitor- (IMP) celle, hvor cellen på sin overflade udtrykker detekterbare niveauer af MIC A/B, CD304 (neuropilin 1), CD178 (FAS-ligand), CD289 (Toll-lignende receptor 9), CD363 (sphingosin-1-phosphatreceptor 1), CD99, CD181 (C-X-C chemokin-receptor type 1; CXCR1), epidermal vækstfaktorreceptor (EGF-R), CXCR2 og CD126.
2. IMP-celle ifølge krav 1, hvor: (a) IMP-cellen er i stand til at migrere til, binde til, proliferere i, have anti-inflammatoriske virkninger i og/eller fremme angiogenese i et specifikt, beskadiget væv hos en patient; (b) IMP-cellen er i stand til at transmigrere gennem det vaskulære endothel til et specifikt, beskadiget væv hos en patient; (c) IMP-cellen er i stand til at migrere til, binde til, proliferere i, have anti-inflammatoriske virkninger i og/eller fremme angiogenese i beskadiget hjerte-, knogle-, brusk-, sene-, ledbånds-, lever-, nyre- eller lungevæv hos en patient; eller (d) IMP-cellen er i stand til at transmigrere gennem det vaskulære endothel til beskadiget hjerte-, knogle-, brusk-, sene-, ledbånds-, lever-, nyre- eller lungevæv hos en patient.
3. IMP-celle ifølge krav 1 eller 2, hvor: (a) IMP-cellen er i stand til at differentiere til en mesodermalcelle in vitro; (b) IMP-cellen er autolog eller allogen; og/eller (c) IMP-cellen er ladet eller transficeret in vitro eller ex vivo med et terapeutisk og/eller diagnostisk middel.
4. Population af to eller flere IMP-celler ifølge et hvilket som helst af de foregående krav.
5. Population af immunmodulatorisk progenitor- (IMP) celler, hvor (i) mindst 90 % af cellerne i populationen på deres overflader udtrykker detekterbare niveauer af MIC A/B, (ii) mindst 60 % af cellerne i populationen på deres overflader udtrykker detekterbare niveauer af CD304 (neuropilin 1), (iii) mindst 45 % af cellerne i populationen på deres overflader udtrykker detekterbare niveauer af CD 178 (FAS-ligand), (iv) mindst 10 % af cellerne i populationen på deres overflader udtrykker detekterbare niveauer af CD289 (Toll-lignende receptor 9), (v) mindst 15 % of populationen på deres overflader udtrykker detekterbare niveauer af CD363 (sphingosin-1-phosphatreceptor 1), (vi) mindst 20 % af cellerne i populationen på deres overflader udtrykker detekterbare niveauer af CD99, (vii) mindst 80 % af cellerne i populationen på deres overflader udtrykker detekterbare niveauer af CD181 (C-X-C chemokin-receptor type 1; CXCR1), (viii) mindst 30 % af cellerne i populationen på deres overflader udtrykker detekterbare niveauer af epidermal vækstfaktorreceptor (EGF-R), (xi) mindst 60 % af cellerne i populationen på deres overflader udtrykker detekterbare niveauer af CXCR2 og (x) mindst 5 % af cellerne i populationen på deres overflader udtrykker detekterbare niveauer af CD126.
6. Population ifølge krav 5, hvor (a) (i) mindst 97 % af cellerne i populationen på deres overflader udtrykker detekterbare niveauer af MIC A/B, (ii) mindst 65 % af cellerne i populationen på deres overflader udtrykker detekterbare niveauer af CD304 (neuropilin 1), (iii) mindst 51 % af cellerne i populationen på deres overflader udtrykker detekterbare niveauer af CD178 (FAS-ligand), (iv) mindst 11 % af cellerne i populationen på deres overflader udtrykker detekterbare niveauer af CD289 (Toll-lignende receptor 9), (v) mindst 18 % af populationen på deres overflader udtrykker detekterbare niveauer af CD363 (sphingosin-1-phosphatreceptor 1), (vi) mindst 24 % af cellerne i populationen på deres overflader udtrykker detekterbare niveauer af CD99, (vii) mindst 85 % af cellerne i populationen udtrykker detekterbare niveauer af CD181 (CXCR1), (viii) mindst 33 % af cellerne i populationen udtrykker detekterbare niveauer af epidermal vækstfaktorreceptor (EGF-R), (ix) mindst 68 % af cellerne i populationen udtrykker detekterbare niveauer af CXCR2 og (x) mindst 7 % af cellerne i populationen udtrykker detekterbare niveauer af CD 126; (b) mindst 90 % af cellerne i populationen på deres overflader udtrykker detekterbare niveauer af én eller flere af, eller samtlige af, 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 og CD276; (c) mindst 80 % af cellerne i populationen på deres overflader udtrykker detekterbare niveauer af én eller flere af, eller samtlige af, CD156b, CD61, CD202b, CD130, CD148, CD288, CD337, SSEA-4, CD349 og CD140b; (d) mindst 70 % af cellerne i populationen på deres overflader udtrykker detekterbare niveauer af én eller flere af, eller samtlige af, CD318, CD351, CD286, CD46, CD119 og CD132; (e) 1 % eller færre af cellerne i populationen på deres overflader udtrykker detekterbare niveauer af én eller flere af, eller samtlige af, 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 alpha 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 og CD24; (f) populationen har de egenskaber, der er defineret i krav 2 eller 3; og/eller (g) populationen omfatter mindst 5000 celler, mindst 50.000 celler eller mindst 250.000 celler.
7. Farmaceutisk sammensætning, der omfatter (a) en IMP-celle ifølge et hvilket som helst af kravene 1 til 3 eller en population ifølge et hvilket som helst af kravene 4 til 6 og (b) farmaceutisk acceptabel bærer eller fortynder, ét eller flere liposomer og/eller én eller flere mikrobobler.
8. Fremgangsmåde til fremstilling af en population af IMP-celler ifølge et hvilket som helst af kravene 4 til 6, hvilken fremgangsmåde omfatter (i) dyrkning af mononukleære blodceller celler (MC’er) i fra 15 til 25 dage i et medium omfattende blodpladelysat, ved mindre end 20 % oxygen (02) og under forhold, der gør det muligt for IMP-cellerne at binde for at inducere differentiering af MC’erne i IMP-celler og (ii) høstning og dyrkning af de IMP-celler, der har et ekspressionsmønster som defineret i 1 og derved produktion af en population ifølge et hvilket som helst af kravene 4 til 6.
9. Fremgangsmåde ifølge krav 8, hvor: (a) MC’erne er perifere mononukleære blodceller (PBMC); og/eller (b) MC’erne opnås fra en patient eller en allogen donor.
10. Population ifølge et hvilket som helst af kravene 4 til 6 eller farmaceutisk sammensætning ifølge krav 7 til anvendelse i en fremgangsmåde til reparation af et beskadiget væv hos en patient eller til behandling af en hjerte-, knogle-, brusk-, sene-, ledbånds-, lever-, nyre- eller lungelæsion eller -sygdom hos en patient.
11. Population ifølge krav 10 til anvendelse ifølge krav 10, hvor: (i) det beskadigede væv stammer fra mesoderm; (ii) det beskadigede væv er hjerte-, knogle-, brusk-, sene-, ledbånds-, lever-, nyre- eller lungevæv; og/eller (iii) det beskadigede væv er beskadiget af læsion eller sygdom; eller (i) hjernelæsionen eller -sygdommen er udvalgt fra myokardieinfarkt, venstresidig ventrikelhypertrofi, højresidig ventrikelhypertrofi, emboli, hjertesvigt, kongenital hjertedeficiens, hjerteklap, arytmi og myokarditis, og/eller populationen produceres ved anvendelse af MC’er opnået fra patienten eller en allogen donor; eller (ii) knoglelæsion eller -sygdommen er udvalgt fra fraktur, Salter-Harris fraktur, greenstick-fraktur, knoglespore, kraniosynostose, Coffin-Lowry-syndrom, fibrodysplasia ossificans progressive, fibrøs dysplasi, Fong Sygdom (eller negle-patella-syndrom), hypofosfatasi, Klippel-Feil-syndrom, metabolisk knoglesygdom, negle-patella-syndrom, osteoarthritis, osteitis deformans (eller Pagets knoglesygdom), osteitis fibrosa cystica (eller osteitis fibrosa eller Von Recklinghausens knoglesygdom), osteitis pubis, kondenserende osteitis (eller osteitis condensans), osteitis condensans ilii, osteochondritis dissecans, osteogenesis imperfecta, osteomalaci, osteomyelitis, osteopeni, osteopetrose, osteoporose, osteonekrose, porotisk hyperostoe, primær hyperparathyroidisme, renal osteodystrofi, knoglecancer, en knoglelæsion forbundet med metastatisk cancer, Gorham Stout-sygdom, primær hyperparathyreoidisme, periodontal sygdom og aseptisk løsning af lederstatninger, og/eller populationen produceres ved anvendelse af MC’er opnået fra patienten eller en allogen donor.
12. Population ifølge krav 10 til anvendelse ifølge krav 10 eller 11, hvor populationen produceres ved anvendelse af MC’er opnået fra patienten eller en allogen donor.
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