Samfurin sel mai igiyar cibi yanzu FDA ta karbe shi

BLA (Aikace-aikacen Lasisin Halittu) na samfurin “HPC-Cord Blood”, an ƙaddamar da shi ga FDA a ranar 7 ga Janairu, 2022, kuma an sanar da StemCyte bisa hukuma a ranar 8 ga Maris, 2022, cewa ƙaddamarwar ta kasance karɓuwa don shigar da ingancin lasisin nazarin halittu. tsari.

"HPC-Cord Blood" samfurin sel na hematopoietic ne na cibiya wanda aka yi niyya don hanyoyin dasawa na masu bayarwa marasa alaƙa tare da tsarin shirye-shiryen da ya dace don gyaran hematopoietic da immunologic a cikin marasa lafiya tare da rikice-rikicen da ke shafar tsarin hematopoietic. Tun lokacin da aka fara samun nasarar amfani da jinin cibiya na farko don kula da marasa lafiya na Fanconi Anemia a cikin 1988, an sami nasarar dashen jini fiye da 40,000 a duk duniya don magance cututtukan cututtukan cututtukan jini da tsarin rigakafi da cututtukan da ke haifar da rayuwa.

A cikin shekaru 20 da suka gabata, StemCyte ya ba da fiye da sassan jini na igiya 2,200 don dasawa ga 1 cikin 20 marasa lafiya a duk duniya waɗanda ke karɓar dashen jinin cibiya. Kayayyakin StemCyte sun ci gaba da cika ƙa'idodin ƙungiyoyin masu ba da izini na ƙasa da ƙasa kuma an amince da su da aminci da inganci ta aƙalla cibiyoyin dasawa 350 a duniya gami da sanannun cibiyoyin kiwon lafiya kamar: Asibitin Jami'ar Duke, Cibiyar Kiwon Lafiya ta UCLA, Tunawa da Taiwan Chang Gung Memorial. Asibiti, National Taiwan University Hospital.

StemCyte wani kamfani ne mai sabuntawa wanda ke haɓaka samfuran bututun mai tare da samar da sabis na banki na jini na jama'a da masu zaman kansu. Baya ga FDA ta Amurka ta amince da Mataki na II na ƙasa da ƙasa da yawa na gwajin asibiti na ɗan adam don bincikensa na maganin raunin kashin baya, layin samfuran maganin tantanin halitta kuma sun haɗa da wasu gwaje-gwajen asibiti da yawa na ɗan adam da ke ci gaba a wajen Amurka don maganin bugun jini na ischemic. , bugun jini na yau da kullun, da palsy na cerebral. Ana shirin fara haɓaka maganin rigakafin cutar kansa a wannan shekara. Bankin jinin igiyar StemCyte na kabilu dabam-dabam tare da daidaiton adadin majinyata daga kabilu daban-daban da yawa idan aka kwatanta da sauran bankunan jinin igiyar jama'a. StemCyte yana ɗaukar bankin cibiya na jini a matsayin babban ƙarfinsa, yayin da yake ƙoƙarin neman sabbin alamun farfadowa na ƙwayoyin cuta. Manufar StemCyte ita ce ta ci gaba da haɓaka ƙarfin banki na igiyar jini na musamman don cimma burin isar da magungunan ceton rai ga marasa lafiya waɗanda ke fama da lalacewa da sauran cututtukan da ke barazanar rayuwa.