An amince da Ryoncil don maganin cututtukan cututtuka na steroid-refractory m graft-versus-host disease (SR-aGVHD), yanayin barazanar rai wanda zai iya haifar da dashen kwayar halitta na jini wanda aka yi don maye gurbin sel masu lahani na mai karɓa a cikin wasu nau'in ciwon daji na jini. , ciwon jini ko rashin lafiyar tsarin rigakafi. Wannan ya sa Ryoncil ya zama na farko da FDA ta amince da MSC (Mesenchymal Stem Cell). Ryoncil yana ƙunshe da MSC waɗanda ke ware daga ƙashin ƙashi na masu ba da gudummawar ɗan adam lafiyayye waɗanda zasu iya bambanta zuwa wasu nau'ikan sel da yawa. Jikodin jiko na ƙwayoyin jijiyoyi na mesenchymal (MSCs) suna ba da fa'idodin rayuwa.
A ranar 18 ga Disamba 2024, FDA yarda Ryoncil (remestemcel-L-rknd), wani allogeneic (mai bayarwa) kasusuwan kasusuwa-wanda aka samu mesenchymal stromal cell (MSC) far don maganin cututtukan steroid-refractory m graft-versus-host disease (SR-aGVHD) a cikin marasa lafiya na yara watanni 2 na shekaru da kuma manya. Wannan ya sa Ryoncil ya zama na farko da FDA ta amince da MSC (Mesenchymal Stem Cell).
Ryoncil yana ƙunshe da MSC waɗanda ke ware daga ƙashin ƙashi na masu ba da gudummawar ɗan adam lafiyayye waɗanda zasu iya bambanta zuwa wasu nau'ikan sel da yawa.
Steroid-refractory m graft-versus-host disease (SR-aGVHD) wani yanayi ne mai tsanani kuma mai barazana ga rayuwa wanda zai iya samun gagarumin sakamako na kiwon lafiya, ciki har da lalacewa ga gabobin da yawa, rage ingancin rayuwa da haɗarin mutuwa a cikin abin da ya shafa. marasa lafiya. Wannan na iya faruwa a matsayin rikitarwa na allogeneic hematopoietic (jini) dashen kwayar halitta (allo-HSCT).
A cikin allo-HSCT, mai haƙuri yana karɓar ƙwayoyin jini na hematopoietic daga mai ba da gudummawa mai lafiya don maye gurbin ƙwayoyin jikin su kuma ya samar da sababbin ƙwayoyin jini, hanyar da ake yi sau da yawa a matsayin wani ɓangare na jiyya ga wasu nau'in ciwon daji na jini, cututtuka na jini ko cututtuka na tsarin rigakafi.
Amincewa da Ryoncil ya biyo bayan kimanta amincinsa da ingancinsa a cikin cibiyar da yawa, binciken hannu guda ɗaya wanda ya ƙunshi mahalarta 54 na yara tare da SR-aGVHD waɗanda suka yi allo-HSCT. Mahalarta taron sun karɓi jimillar jiko na Ryoncil guda takwas na jijiya sau biyu a mako har tsawon makonni huɗu a jere. Kima na tasiri ya dogara da farko akan ƙimar da tsawon lokacin amsawa ga jiyya kwanaki 28 bayan fara Ryoncil.
A cikin wani gwaji na SR-aGVHD bayan allo-HSCT, an gano cewa haɗuwa da MSCs da basiliximab (wani antibody monoclonal da aka yi amfani da shi don hana ƙin dasawa) yana haifar da mafi kyawun amsawa (CR) fiye da basiliximab kadai.
An lura da shi a cikin gwaje-gwajen asibiti cewa jiko na IV na ƙwayoyin stromal stromal (MSCs) yana ba da fa'idodin rayuwa.
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References:
- Sakin Labaran FDA - FDA Ta Amince da Farko Mesenchymal Stromal Cell Therapy don Magance Cutar Cutar Cutar Siroriod-Mai Rarrabewa. An buga 18 Disamba 2024. Akwai a https://www.fda.gov/news-events/press-announcements/fda-approves-first-mesenchymal-stromal-cell-therapy-treat-steroid-refractory-acute-graft-versus-host
- Fu, H., Sun, X., Lin, R. et al. Mesenchymal stromal Kwayoyin da basiliximab suna inganta amsawar cututtukan steroid-refractory m graft-versus-host disease azaman jiyya na layi na biyu: cibiyar da yawa, bazuwar, gwajin sarrafawa. BMC Med 22, 85 (2024). https://doi.org/10.1186/s12916-024-03275-5
- Kelly, K., Bloor, AJC, Griffin, JE et al. Sakamakon aminci na shekaru biyu na iPS cell-samun mesenchymal stromal sel a cikin m steroid-resistant graft-versus-host disease. Nat Med 30, 1556-1558 (2024). https://doi.org/10.1038/s41591-024-02990-z
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