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Mesenchymal Stem Cell (MSC) Therapy: FDA Inobvumira Ryoncil 

Ryoncil yakatenderwa kurapa steroid-refractory acute graft-versus-host disease (SR-aGVHD), chirwere chinotyisidzira hupenyu chinogona kubva muropa re stem cell transplantation yakaitwa kutsiva masero akaremara emugamuchiri mune mamwe marudzi egomarara reropa. , kusagadzikana kweropa kana immune system kusagadzikana. Izvi zvinoita kuti Ryoncil ive yekutanga FDA-yakatenderwa MSC (Mesenchymal Stem Cell) kurapwa. Ryoncil ine MSCs yakaparadzaniswa kubva mumwongo wevanhu vakuru vane hutano vanopa iyo inogona kusiyanisa mune akawanda mamwe marudzi emasero. Intravenous infusions ye mesenchymal stromal cells (MSCs) inopa mabhenefiti ekupona.  

Musi wa18 Zvita 2024, FDA yakabvumirwa Ryoncil (remestemcel-L-rknd), an allogeneic (donor) bone marrow-yakagadzirwa mesenchymal stromal cell (MSC) kurapwa kwe steroid-refractory acute graft-versus-host disease (SR-aGVHD) muvana varwere mwedzi miviri. vezera nevakuru. Izvi zvinoita kuti Ryoncil ive yekutanga FDA-yakatenderwa MSC (Mesenchymal Stem Cell) kurapwa.  

Ryoncil ine MSCs yakaparadzaniswa kubva mumwongo wevanhu vakuru vane hutano vanopa iyo inogona kusiyanisa mune akawanda mamwe marudzi emasero.  

Steroid-refractory acute graft-versus-host disease (SR-aGVHD) chirwere chakakomba uye chinotyisa chinogona kuva nemigumisiro yakakura yehutano, kusanganisira kukuvadzwa kwemitezo yakawanda, kuderedzwa kwehupenyu uye njodzi yekufa mune zvakakanganiswa. varwere. Izvi zvinogona kuitika sechikanganiso che allogeneic hematopoietic (ropa) stem cell transplantation (allo-HSCT).   

Mune allo-HSCT, murwere anogamuchira hematopoietic stem masero kubva kune ane hutano anopa kutsiva ega masero uye kugadzira masero matsva eropa, maitiro anowanzo kuitwa sechikamu chekurapa kune mamwe marudzi eropa regomarara, kusagadzikana kweropa kana immune system kusagadzikana. 

Kubvumirwa kweRyoncil kunotevera kuongororwa kwekuchengetedza uye kushanda kwayo mune yakawandacentre, chidzidzo cheruoko chimwechete chinosanganisira vatori vechikamu makumi mashanu nevana vane SR-aGVHD avo vakamboitwa allo-HSCT. Vatori vechikamu vakagamuchira huwandu husere intravenous infusions yeRyoncil kaviri pasvondo kwemavhiki mana akateedzana. Kuongororwa kwekubudirira kwakavakirwa kunyanya pachiyero uye nguva yekupindura kurapwa kwemazuva makumi maviri nemasere mushure mekutanga Ryoncil. 

Mune kumwe kuedzwa kweSR-aGVHD mushure meallo-HSCT, zvakaonekwa kuti musanganiswa weMSCs uye basiliximab (monoclonal antibody inoshandiswa kudzivirira kurambwa kwekutapurirana) inotungamira kumhinduro yakakwana yakakwana (CR) iri nani pane basiliximab yega.

Zvakaonekwa mumakiriniki ekuedzwa kuti IV infusions ye mesenchymal stromal cell (MSCs) inopa mabhenefiti ekupona. 

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References:  

  1. FDA Nhau Kuburitswa - FDA Inobvumidza Kutanga Mesenchymal Stromal Cell Therapy Kurapa Steroid-refractory Acute Graft-versus-host Disease. Yakatumirwa 18 Zvita 2024. Inowanikwa pa https://www.fda.gov/news-events/press-announcements/fda-approves-first-mesenchymal-stromal-cell-therapy-treat-steroid-refractory-acute-graft-versus-host  
  1. Fu, H., Zuva, X., Lin, R. et al. Mesenchymal stromal cells pamwe nebasiliximab inovandudza mhinduro ye steroid-refractory acute graft-versus-host disease sechipiri-mutsara therapy: multicentre, randomized, controlled trial. BMC Med 22, 85 (2024). https://doi.org/10.1186/s12916-024-03275-5 
  1. Kelly, K., Bloor, AJC, Griffin, JE et al. Makore maviri ekuchengetedza mhedzisiro yePS cell-yakatorwa mesenchymal stromal masero mune acute steroid-resistant graft-versus-host chirwere. Nat Med 30, 1556–1558 (2024). https://doi.org/10.1038/s41591-024-02990-z 

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