BLA (Biologics License Application) bakeng sa sehlahisoa sa "HPC-Cord Blood", e rometsoe ho FDA ka la 7 Pherekhong 2022, mme StemCyte e ile ea tsebisoa ka molao ka la 8 Hlakubele 2022, hore tlhahiso e amohetsoe ho kenya tlhahlobo ea boleng ba laesense ea biologics. tshebetso.
"HPC-Cord Blood" ke sehlahisoa sa lisele tsa mali tsa umbilical cord blood hematopoietic stem cell se reretsoeng mekhoa e sa amaneng ea mofani oa hematopoietic progenitor cell transplantation hammoho le mokhoa o loketseng oa ho itokisa bakeng sa ho tsosolosoa ha mali le immunologic ho bakuli ba nang le mathata a amanang le tsamaiso ea hematopoietic. Ho tloha ts'ebelisong ea pele e atlehileng ea mali a mokhubu ho alafa bakuli ba Fanconi Anemia ka 1988, ho bile le li-transplant tsa mali tse atlehileng ho feta 40,000 lefatšeng ka bophara bakeng sa kalafo ea mafu a tsamaiso ea methapo ea mali le ea 'mele ea ho itšireletsa mafung hammoho le mafu a metabolic a tsoaloa.
Lilemong tse 20 tse fetileng, StemCyte e fane ka li-unit tsa mali tse fetang 2,200 bakeng sa ho fetisetsa motho a le mong ho bakuli ba 1 lefatšeng ka bophara ba fumanang li-transplant tsa mali. Lihlahisoa tsa StemCyte li lula li kopana le litekanyetso tsa boleng ba mekhatlo ea machaba e amohelehang 'me li amoheloa ebile li tšeptjoa e le tse sireletsehileng le tse sebetsang bonyane ke litsi tsa transplant tsa 20 ho pota lefatše ho kenyeletsa le litsi tse tsebahalang tsa bongaka tse kang: Duke University Hospital, UCLA Medical Center, Taiwan Chang Gung Memorial. Sepetlele, Sepetlele sa Naha sa Univesithi ea Taiwan.
StemCyte ke k'hamphani ea regenerative cell therapy e ntseng e nts'etsapele lihlahisoa tsa lipeipi tsa kalafo ea lisele hammoho le ho fana ka lits'ebeletso tsa banka ea mali ea sechaba le ea poraefete. Ntle le teko ea bongaka ea batho ea Phase II e lumelletsoeng ke US FDA bakeng sa kalafo ea eona ea ho lemala ha lesapo la mokokotlo, mela ea sehlahisoa sa cell therapy e kenyelletsa liteko tse ling tsa batho tse ntseng li tsoela pele kantle ho US bakeng sa kalafo ea acute ischemic stroke. , setorouku se sa foleng, le lefu la cerebral palsy. Nts'etsopele ea immunotherapy ea mofetše e reretsoe ho qala selemong sena. StemCyte's cord blood bank ke merabe e mengata ka sekhahla se lekanang sa bakuli ba merabe e fapaneng se batlang se le holimo ha se bapisoa le libanka tse ling tsa sechaba. StemCyte e nka "umbilical cord banking" e na le bokhoni ba eona ba mantlha, ha e ntse e phehella ka mafolofolo lipontšo tse ncha tsa kalafo ea lisele. Morero oa StemCyte ke ho tsoela pele ho nts'etsapele bokhoni ba eona bo ikhethang ba ho boloka mali ho fihlela sepheo sa ho fana ka liphekolo tse pholosang bophelo ho bakuli ba tšoeroeng ke lefu la ho fokola le mafu a mang a behang bophelo kotsing.
SEO U LOKELANG HO SE NKA HO SEHLOOHO ENA:
- 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.
