Ukuhlolwa kulindeleke ukuthi kuhlele ngokungahleliwe iziguli ezifakelwa izinso ezizwela kakhulu ezingama-64 nge-cPRA engu-≥99.9%, emele isethi yeziguli ezizwela kakhulu eziqhubeka nokuncishwa amathuba naphezu kokubekwa phambili ngaphansi kohlelo lwase-US lokwabiwa kwezinso. Lapho isitho somnikeli sitholakala futhi ukungqubuzana okuhle nomamukeli ohlosiwe kubonisa ukuthi isitho asihambisani, isiguli sizohlelwa ngokungahleliwe ekwelashweni kwe-imlifidase desensitization noma ingalo yokulawula ezothola ukunakekelwa okujwayelekile (okungukuthi ukulinda okuhambisanayo kakhudlwana. ukunikezwa kwezinso noma ukuthola ukwelashwa kokuhlolwa kokuqeda ukungezwani komzimba). Isiphetho esiyinhloko socwaningo se-imlifidase sokuhlola inzuzo ekufakeleni kabusha iziguli ezizwela kakhulu umsebenzi wokufakwa kwezinso ezinyangeni eziyi-12, kukalwa nge-eGFR (i-Glomerular Filtration Rate elinganiselwe).
Imigomo yocwaningo lwe-ConfIdeS ihambisana “Ne-Advancing American Kidney Health” (“AAKH”) US Executive Order (https://kidney360.asnjournals.org/content/1/6/557), egxile ezintweni ezintathu ezibanzi. imigomo: (1) ukunciphisa ingozi yokwehluleka kwezinso; (2) ukuthuthukisa ukufinyelela kanye nekhwalithi yezinketho zokwelashwa ezigxile kumuntu; kanye (3) nokwandisa ukufinyelela ekufakweni kwezinso, okubili kokugcina kuhlanganiswe ngokuqondile nokwandisa ukufakelwa kabusha.
U-Robert A. Montgomery, MD, uProfesa Wokuhlinza kanye noMqondisi, i-NYU Langone Transplant Institute eNew York City, uqokwe njengoMphenyi Kazwelonke Wokuxhumanisa wecala le-ConfIdeS. Ukuhlolwa kuzobhalisa iziguli ezikhungweni ezihola phambili eziyi-12 kuye kweziyi-15 e-US
Ukuphothulwa kokubhaliswa ocwaningweni kulindeleke engxenyeni yesibili ka-2022, kanti isikhathi sokufunda sokulandelela esiyizinyanga eziyi-12 kulindeleke ukuthi siqedwe engxenyeni yesibili ka-2023. Imiphumela yalolu hlolo olubalulekile kulindeleke ukuthi isekele ukuthunyelwa kwe-BLA okungaba khona i-FDA ngaphansi kwendlela yokugunyazwa esheshisiwe engxenyeni yokuqala ka-2024.
I-Imlifidase isivele ithole imvume yokuthengisa enemibandela e-Europe yokwelashwa kokungazweli kweziguli ezikhungathekiswe kakhulu zokufakelwa izinso ezinomphumela omuhle ngokumelene nomnikezeli oshonile otholakalayo.
