Mesenchymal Stem Cell (MSC) Kev Kho Mob: FDA Pom Zoo Ryoncil 

Ryoncil tau txais kev pom zoo rau kev kho mob ntawm steroid-refractory acute graft-tiv thaiv-tus kab mob (SR-aGVHD), uas yuav ua rau muaj kev phom sij rau lub neej uas yuav tshwm sim los ntawm kev hloov ntshav qia cell ua los hloov cov neeg tau txais cov kab mob tsis zoo hauv qee hom qog ntshav ntshav. , ntshav tsis txaus lossis kev tiv thaiv kab mob. Qhov no ua rau Ryoncil thawj FDA pom zoo MSC (Mesenchymal Stem Cell) kho. Ryoncil muaj MSCs cais tawm ntawm cov pob txha ntawm cov neeg laus noj qab haus huv cov neeg pub dawb uas tuaj yeem sib txawv rau ntau hom hlwb. Intravenous infusions ntawm mesenchymal stromal cells (MSCs) muab cov txiaj ntsig muaj sia nyob.  

Lub Kaum Ob Hlis 18, 2024, FDA Kev pom zoo Ryoncil (remestemcel-L-rknd), ib qho allogeneic (tus pub dawb) cov pob txha pob txha-derived mesenchymal stromal cell (MSC) kev kho mob ntawm steroid-refractory acute graft-tiv thaiv-tus kab mob (SR-aGVHD) hauv cov neeg mob 2 lub hlis ntawm hnub nyoog thiab laus dua. Qhov no ua rau Ryoncil thawj FDA pom zoo MSC (Mesenchymal Stem Cell) kho.  

Ryoncil muaj MSCs cais tawm ntawm cov pob txha ntawm cov neeg laus noj qab haus huv cov neeg pub dawb uas tuaj yeem sib txawv rau ntau hom hlwb.  

Steroid-refractory acute graft-tiv thaiv-tus kab mob (SR-aGVHD) yog ib qho mob hnyav thiab ua rau muaj kev phom sij rau lub neej uas tuaj yeem ua rau muaj kev cuam tshuam loj, muaj kev noj qab haus huv ntau yam, suav nrog kev puas tsuaj rau ntau lub cev, txo lub neej zoo thiab kev pheej hmoo ntawm kev tuag hauv kev cuam tshuam. cov neeg mob. Qhov no tuaj yeem tshwm sim raws li qhov teeb meem ntawm allogeneic hematopoietic (ntshav) qia cell transplantation (allo-HSCT).   

Nyob rau hauv allo-HSCT, tus neeg mob tau txais hematopoietic qia hlwb los ntawm tus neeg noj qab haus huv pub dawb los hloov lawv cov qia hlwb thiab tsim cov qe ntshav tshiab, ib txoj kev ua feem ntau ua ib feem ntawm kev kho mob rau qee hom qog ntshav ntshav, ntshav tsis txaus lossis kev tiv thaiv kab mob. 

Kev pom zoo ntawm Ryoncil ua raws li kev soj ntsuam ntawm nws txoj kev nyab xeeb thiab kev ua tau zoo hauv ntau qhov chaw, ib sab caj npab kawm nrog 54 tus neeg koom nrog SR-aGVHD uas tau dhau los ntawm allo-HSCT. Cov neeg koom tau txais tag nrho yim qhov kev txhaj tshuaj ntawm Ryoncil ob zaug hauv ib lub lis piam rau plaub lub lis piam sib law liag. Qhov kev ntsuam xyuas ntawm kev ua tau zoo yog ua raws li tus nqi thiab lub sijhawm ntawm cov lus teb rau kev kho mob 28 hnub tom qab pib Ryoncil. 

Hauv lwm qhov kev sim rau SR-aGVHD tom qab allo-HSCT, nws tau pom tias kev sib xyaw ua ke ntawm MSCs thiab basiliximab (ib qho tshuaj tiv thaiv kab mob monoclonal siv los tiv thaiv kev hloov pauv tsis lees paub) ua rau cov lus teb zoo dua (CR) ntau dua li basiliximab ib leeg.

Nws tau raug pom nyob rau hauv kev sim tshuaj uas IV infusions ntawm mesenchymal stromal cells (MSCs) muab cov txiaj ntsig muaj sia nyob. 

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References:  

1. FDA Xov Xwm Tshaj Tawm - FDA Pom Zoo Thawj Mesenchymal Stromal Cell Therapy los kho Steroid-refractory Acute Graft-vs-tus kab mob. Tshaj tawm 18 Kaum Ob Hlis 2024. Muaj nyob ntawm https://www.fda.gov/news-events/press-announcements/fda-approves-first-mesenchymal-stromal-cell-therapy-treat-steroid-refractory-acute-graft-versus-host  

2. Fu, H., Sun, X., Lin, R. et al. Mesenchymal stromal hlwb ntxiv rau basiliximab txhim kho cov lus teb ntawm steroid-refractory mob graft-tiv thaiv-tus kab mob raws li kev kho mob thib ob: ntau qhov chaw, randomized, tswj kev sim. BMC Med 22, 85 (2024). https://doi.org/10.1186/s12916-024-03275-5 

3. Kelly, K., Bloor, AJC, Griffin, JE et al. Ob xyoos kev nyab xeeb tshwm sim ntawm iPS cell-derived mesenchymal stromal hlwb nyob rau hauv mob steroid-resistant graft-tiv thaiv-tus kab mob. Nat Med 30, 1556–1558 (2024). https://doi.org/10.1038/s41591-024-02990-z 

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