Unyango lwe-Mesenchymal Stem Cell (MSC): I-FDA ivuma iRyoncil 

I-Ryoncil ivunyiwe kunyango lwe-steroid-refractory acute graft-versus-host disease (SR-aGVHD), imeko esongela ubomi enokuthi ibangele ukutshintshwa kweeseli zegazi ezenziweyo ukuze kuthathelwe indawo iiseli ze-stem ezineziphene kwiintlobo ezithile zomhlaza wegazi. , ukuphazamiseka kwegazi okanye ukuphazamiseka kwe-immune system. Oku kwenza i-Ryoncil ibe lunyango lokuqala oluvunywe yi-FDA ye-MSC (iMesenchymal Stem Cell). I-Ryoncil iqulethe ii-MSCs ezibekwe zodwa kumongo wabantu abadala abasempilweni abanikelayo abanokwahlula kwiintlobo ezininzi zeeseli. Ukufakwa kwi-intravenous yeeseli ze-mesenchymal stromal (MSCs) zibonelela ngeenzuzo zokuphila.  

Ngomhla wesi-18 kweyoMnga 2024, FDA i-Ryoncil evunyiweyo (i-remestemcel-L-rknd), i-allogeneic (donor) yonyango lwe-bone marrow-derived mesenchymal stromal cell (MSC) yonyango lwe-steroid-refractory acute graft-versus-host disease (SR-aGVHD) kwizigulane zabantwana iinyanga ezi-2 ubudala nangaphezulu. Oku kwenza i-Ryoncil ibe lunyango lokuqala oluvunywe yi-FDA ye-MSC (iMesenchymal Stem Cell).  

I-Ryoncil iqulathe ii-MSCs ezibekwe zodwa kumongo wabantu abadala abasempilweni abanikelayo abanokuthi bahlule kwiintlobo ezininzi zeeseli.  

I-Steroid-refractory acute graft-versus-host disease (SR-aGVHD) yimeko enzima kwaye ibeka ubomi engozini enokuthi ibe nemiphumo ebalulekileyo, ebanzi yezempilo, kuquka umonakalo kumalungu amaninzi, ukunciphisa umgangatho wobomi kunye nomngcipheko wokufa kwabachaphazelekayo. izigulane. Oku kunokwenzeka njengengxaki ye-allogeneic hematopoietic (igazi) i-stem cell transplantation (i-allo-HSCT).   

Kwi-allo-HSCT, isigulane sifumana iiseli ze-hematopoietic stem ezivela kumnikeli ophilileyo ukuze zitshintshe iiseli zazo ze-stem kwaye zenze iiseli zegazi ezintsha, inkqubo edlalwa rhoqo njengenxalenye yonyango lweentlobo ezithile zomhlaza wegazi, ukuphazamiseka kwegazi okanye ukuphazamiseka kwe-immune system. 

Ukuvunywa kweRyoncil kulandela uvavanyo lokhuseleko lwayo kunye nokusebenza kwayo kumaziko amaninzi, uphando lwengalo enye olubandakanya abathathi-nxaxheba babantwana abangama-54 abane-SR-aGVHD abaye bafumana i-allo-HSCT. Abathathi-nxaxheba bafumene i-infusions ye-Ryoncil ye-intravenous esibhozo kabini ngeveki kwiiveki ezine ezilandelelanayo. Uvavanyo lwentsebenzo lwalusekelwe ngokukodwa kwisantya kunye nobude bokuphendula kunyango lweentsuku ze-28 emva kokuqalisa iRyoncil. 

Kolunye ulingo lwe-SR-aGVHD emva kwe-allo-HSCT, kwafunyaniswa ukuba indibaniselwano ye-MSCs kunye ne-basiliximab (i-antibody ye-monoclonal esetyenziselwa ukuthintela ukwaliwa kwe-transplant) ikhokelela kwinqanaba elingcono kakhulu lokuphendula (CR) kune-basiliximab yodwa.

Kuye kwaphawulwa kulingo lwezonyango ukuba i-IV infusions yeeseli ze-mesenchymal stromal (MSCs) zibonelela ngeenzuzo zokuphila. 

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Iingxelo:  

1. Ukukhutshwa kweendaba ze-FDA - i-FDA ivuma i-First Mesenchymal Stromal Cell Therapy ukuNyanga i-Steroid-refractory Acute Graft-versus-host Disease. Ithunyelwe nge-18 kuDisemba 2024. Iyafumaneka e 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. Iiseli ze-Mesenchymal stromal kunye ne-basiliximab ziphucula impendulo ye-steroid-refractory acute graft-versus-host disease njengonyango lomgca wesibini: ulingo oluninzi, olungenamkhethe, olulawulwayo. BMC Med 22, 85 (2024). https://doi.org/10.1186/s12916-024-03275-5 

3. Kelly, K., Bloor, AJC, Griffin, JE et al. Iziphumo zeminyaka emibini zokhuseleko ze-iPS cell-derived mesenchymal stromal cells in acute steroid-resistant graft-versus-host disease. UNat Med 30, 1556–1558 (2024). https://doi.org/10.1038/s41591-024-02990-z 

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