O le BLA (Biologics License Application) mo le oloa "HPC-Cord Blood", na tuʻuina atu i le FDA ia Ianuari 7th, 2022, ma StemCyte na logo aloaia ia Mati 8th, 2022, o le talosaga na talia e ulufale i le biologics license quality review. faiga.
O le "HPC-Cord Blood" o le toto toto hematopoietic stem cell oloa e faʻamoemoeina mo le faʻasoaina o le hematopoietic progenitor cell transplantation procedures faʻatasi ma se faʻatonuga sauniuni talafeagai mo le toe faʻaleleia o le hematopoietic ma le immunologic i tagata mamaʻi ma faʻalavelave e aʻafia ai le hematopoietic system. Talu mai le ulua'i fa'aogaina lelei o le toto o le umbilical cord e togafitia ai tagata mama'i Fanconi Anemia i le 1988, ua silia ma le 40,000 fa'amanuiaina le totoina o le toto i le lalolagi atoa mo le togafitia o fa'ama'i o le hematopoietic ma le immune system fa'apea ma ma'i metabolic inborn.
I le 20 tausaga ua tuana'i, ua saunia e StemCyte le sili atu i le 2,200 iunite toto mo le fa'anofoina i le 1 i le 20 tagata gasegase i le lalolagi atoa o lo'o maua le toto toto. O oloa a StemCyte o loʻo ausia pea tulaga lelei o faʻalapotopotoga faʻavaomalo faʻavaomalo ma e faʻamaonia ma faʻatuatuaina e saogalemu ma aoga e le itiiti ifo ma le 350 nofoaga faʻapipiʻi i le salafa o le lalolagi e aofia ai nofoaga faʻafomaʻi lauiloa e pei o: Duke University Hospital, UCLA Medical Center, Taiwan Chang Gung Memorial Falemai, Falemai a le Iunivesite Aoao o Taiwan.
O le StemCyte ose kamupani fa'afoma'i fa'afoma'i sela o lo'o atia'e oloa fa'aau paipa fa'ama'i sela fa'apea fo'i le tu'uina atu o au'aunaga fa'aputuga toto mo le lautele ma tagata tumaoti. I le faaopoopo atu i le US FDA ua faamaonia le Vaega II multi-national ma multi-center tagata suʻesuʻega falemaʻi mo ana suʻesuʻega o manuʻa o manuʻa, o laina o vailaʻau faʻasolosolo e aofia ai foʻi le tele o isi faʻataʻitaʻiga a le tagata o loʻo faʻagasolo i fafo atu o le US mo togafitiga o le maʻi o le stroke ischemic. , ta'i faaumiumi, ma le supa cerebral. O le atina'eina o le kanesa immunotherapy ua fuafua e amata i lenei tausaga. StemCyte's cord blood bank e tele ituaiga ma le fua faatatau tutusa mo gasegase mai fa'alapotopotoga eseese e maualuga tele pe a fa'atusatusa i isi faletupe toto. E manatu StemCyte e fa'amautu le toto o le umbilical cord i lona agava'a autu, a'o tulituliloaina fa'ailoga fou e fa'afo'isia ai sela. O le misiona a StemCyte o le faʻaauau pea ona atiaʻe ana gafatia faʻapitoa e teu ai toto toto e ausia ai le sini o le tuʻuina atu o togafitiga faʻaola i tagata mamaʻi na mafatia i faʻamaʻi faʻaleagaina ma isi faʻamaʻi e lamatia ai le ola.
OA MEA E AVEA MAI LENEI TUSI:
- Since the first successful use of umbilical cord blood to treat Fanconi Anemia patients in 1988, there have been more than 40,000 successful umbilical cord blood transplants worldwide for the treatment of diseases of the hematopoietic and immune systems as well as inborn metabolic diseases.
- In addition to the US FDA approved Phase II multi-national and multi-center human clinical trial for its investigational spinal cord injury treatment, the cell therapy product lines also include several other human clinical trials in progress outside the US for treatment of acute ischemic stroke, chronic stroke, and cerebral palsy.
- Is an umbilical cord blood hematopoietic stem cell product intended for unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system.
