Imveliso ye-umbilical stem cell cell ngoku yamkelwe yi-FDA

A BAMBA isiKhululo sasimahla 6 | eTurboNews | eTN
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I-BLA (iSicelo seLayisensi yeBiologics) yemveliso ye-“HPC-Cord Blood”, yangeniswa kwi-FDA nge-7 kaJanuwari, ngo-2022, kwaye iStemCyte yaziswa ngokusemthethweni nge-8 kaMatshi, 2022, ukuba ungeniso lwamkelekile ukungena kuphononongo lomgangatho welayisensi yebhayoloji. inkqubo.

"I-HPC-Cord Blood" yi-umbilical cord blood hematopoietic stem cell imveliso ejoliswe kwiinkqubo zokufakelwa kweeseli ze-hematopoietic progenitor cell transplantation kunye ne-regimen efanelekileyo yokulungisa i-hematopoietic kunye ne-immunologic reconstitution kwizigulane ezineengxaki ezichaphazela inkqubo ye-hematopoietic. Ukususela ekusetyenzisweni kokuqala kwe-umbilical cord ukunyanga izigulane ze-Fanconi Anemia kwi-1988, kuye kwakho ngaphezu kwe-40,000 eyimpumelelo yokufakelwa kwegazi kwi-umbilical cord emhlabeni jikelele ukunyanga izifo ze-hematopoietic kunye ne-immune system kunye nezifo ezizalwayo ze-metabolic.

Kwiminyaka engama-20 edlulileyo, iStemCyte ibonelele ngeeyunithi zegazi zentambo ezingaphezulu kwama-2,200 zofakelo kwi-1 kwizigulane ezingama-20 kwihlabathi jikelele ezifumana uqhaqho-gazi lwe-umbilical cord. Iimveliso ze-StemCyte zihlala zihlangabezana nemigangatho yomgangatho wemibutho eqinisekisiweyo yamazwe ngamazwe kwaye ziyamkelwa kwaye zithenjwa njengezikhuselekileyo kwaye zisebenza ubuncinane ngamaziko angama-350 okutshintshwa emhlabeni jikelele kuquka namaziko ezonyango awaziwayo njenge: Isibhedlele saseDuke University, iZiko lezoNyango le-UCLA, iTaiwan Chang Gung Memorial Isibhedlele, iSibhedlele seYunivesithi yeSizwe yaseTaiwan.

I-StemCyte yinkampani yonyango lweeseli ezihlaziyayo ephuhlisa iimveliso zemibhobho yonyango lweeseli kwakunye nokubonelela ngeenkonzo zokubhankisha igazi zikawonke-wonke nezabucala. Ukongeza kwi-US FDA evunyiweyo yeSigaba se-II sovavanyo lwezonyango lwabantu abaninzi kuzwelonke kunye namaziko amaninzi kunyango lokulimala komnqonqo wophando, imigca yemveliso yonyango lweseli ikwabandakanya nolunye ulingo lwezonyango lwabantu oluqhubekayo ngaphandle kwe-US kunyango lwe-acute ischemic stroke. , isifo sohlangothi esingapheliyo, kunye nokukhubazeka ebuchotsheni. Uphuhliso lwe-immunotherapy yomhlaza lucwangciselwe ukuqala kulo nyaka. Ibhanki yegazi ye-StemCyte inezizwe ezininzi ngesantya esihambelanayo kwizigulana ezivela kumaqela ahlukeneyo ezizwe eziphezulu xa kuthelekiswa nezinye iibhanki zegazi zentambo yoluntu. I-StemCyte ithathela ingqalelo i-umbilical cord blood banking yeyona nto iphambili kuyo, ngelixa iqhuba ngenkuthalo izikhombisi ezintsha zonyango lweseli. Injongo yeStemCyte kukuqhubela phambili nokuphuhlisa izakhono zayo ezizodwa zebhanki yegazi ukufezekisa injongo yokuhambisa unyango olusindisa ubomi kwizigulana ezibandezelekileyo kunye nezinye izifo ezisongela ubomi.

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IAvatar kaLinda Hohnholz

Linda Hohnholz

Umhleli oyintloko we eTurboNews esekwe kwi-eTN HQ.

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