Umbilical cord stem cell product tsopano yovomerezedwa ndi FDA

BLA (Biologics License Application) ya chinthu cha "HPC-Cord Blood", idatumizidwa ku FDA pa Januware 7th, 2022, ndipo StemCyte idadziwitsidwa mwalamulo pa Marichi 8, 2022, kuti zomwe zaperekedwazo zinali zovomerezeka kuti zilembetsenso zaubwino wa laisensi ya biologics. ndondomeko.

"HPC-Cord Blood" ndi umbilical cord blood hematopoietic stem cell product yopangidwira osagwirizana ndi opereka hematopoietic progenitor cell transplantation molumikizana ndi dongosolo loyenera lokonzekera kukonzanso kwa hematopoietic ndi immunologic reconstitution kwa odwala omwe ali ndi vuto lomwe limakhudza dongosolo la hematopoietic. Kuyambira bwino ntchito umbilical chingwe magazi kuchiza Fanconi Anemia odwala mu 1988, pakhala oposa 40,000 bwino umbilical chingwe kumuika magazi padziko lonse zochizira matenda a hematopoietic ndi chitetezo cha m`thupi komanso kubadwa matenda kagayidwe kachakudya.

Pazaka 20 zapitazi, StemCyte yapereka mayunitsi a magazi opitilira 2,200 kuti amuike kwa wodwala m'modzi mwa odwala 1 padziko lonse lapansi omwe amalandila umbilical chingwe magazi. Zogulitsa za StemCyte nthawi zonse zimakwaniritsa miyezo yapamwamba ya mabungwe ovomerezeka padziko lonse lapansi ndipo zimadziwika ndi kudaliridwa kuti ndizotetezeka komanso zogwira ntchito ndi malo osachepera 20 padziko lonse lapansi kuphatikiza zipatala zodziwika bwino monga: Duke University Hospital, UCLA Medical Center, Taiwan Chang Gung Memorial Chipatala, National Taiwan University Hospital.

StemCyte ndi kampani ya regenerative cell therapy yomwe ikupanga zinthu zamapaipi a cell therapy komanso kupereka chithandizo chakubanki chamagazi pagulu komanso payekhapayekha. Kuphatikiza pa mayeso a Phase II omwe avomerezedwa ndi FDA a Phase II m'maiko ambiri komanso apakati pazachipatala cha anthu chifukwa chofufuza chithandizo chamankhwala ovulala msana, mizere ya cell therapy imaphatikizansopo mayeso angapo achipatala a anthu omwe akuchitika kunja kwa US kuti athe kuchiza matenda a ischemic stroke. , sitiroko yosatha, ndi cerebral palsy. Development a khansa immunotherapy akukonzekera kuyamba chaka chino. StemCyte's cord blood bank ndi yamitundu yambiri ndipo mulingo wofananira wa odwala ochokera m'mitundu yosiyanasiyana ndiokwera kwambiri poyerekeza ndi nkhokwe zina zosungira magazi. StemCyte imawona kusungitsa magazi kwa umbilical cord kukhoza kwake, kwinaku akutsata zowonetsa zatsopano zama cell. Ntchito ya StemCyte ndikupitiliza kukulitsa luso lake losungira magazi kuti akwaniritse cholinga chopereka chithandizo chopulumutsa moyo kwa odwala omwe akudwala matenda osokonekera komanso oopsa.