Amerykańska Agencja ds. Żywności i Leków (FDA) zatwierdziła produkt medyczny StrataGraft, powstały z dwóch rodzajów ludzkich komórek skóry, przeznaczony do leczenia ciężkich oparzeń termicznych. Rozwiązanie pozwoli ograniczyć interwencje chirurgiczne u pacjentów, którzy doznali głębokich oparzeń.
Firma Mallinckrodt Pharmaceuticals z Irlandii stworzyła alternatywę dla chirurgicznego leczenia oparzeń. Produkt StrataGraft wytwarzany jest z dwóch rodzajów komórek ludzkiej skóry – keratynocytów i fibroblastów, które tworzą tzw. rusztowanie w miejscu oparzenia dla wzrostu nowych komórek.
Leczenie StrataGraft wyeliminowało potrzebę autoprzeszczepu u 71 na 101 pacjentów
StrataGraft jest w formie cienkiego, przezroczystego materiału, o powierzchni około 100 centymetrów kwadratowych. Przeznaczony jest wyłącznie do użytku miejscowego. Produkt można przycinać do rozmiaru rany.
FDA oparła swoją decyzję na podstawie badań klinicznych, które objęły łącznie 101 pacjentów z głębokimi oparzeniami termicznymi. Uczestnicy poddani zostali dwóm metodom leczenia – autoprzeszczepowi oraz produktem StrataGraft. Badacze wykazali, iż leczenie StrataGraft wyeliminowało potrzebę przeszczepu u 71 pacjentów. Po trzech miesiącach leczenia 92 proc. ran pooparzeniowych zamknęło się. Produkt nie został odrzucony przez układ odpornościowy żadnego z pacjentów, nie zgłoszono również przypadków infekcji.
Najczęstszym działaniem niepożądanym było swędzenie (u 11 uczestników badań), powstanie pęcherzy, blizn przerostowych i zaburzenia procesu gojenia się rany. FDA oceniła, że profil bezpieczeństwa StrataGraft jest bardzo podobny do profilu bezpieczeństwa autoprzeszczepu.
StrataGraft może zmniejszyć potrzebę interwencji chirurgicznych
Dr n. med. Peter Marks, dyrektor Centrum Oceny i Badań Biologicznych w FDA, zwraca uwagę, iż oparzenia mogą być niezwykle trudnym do leczenia urazem. W przypadku wielu głębokich oparzeń leczenie często polega na interwencji chirurgicznej, usunięciu uszkodzonych tkanek i zastąpienie ich przeszczepem z innego miejsca ciała pacjenta. Autoprzeszczep pozostawia jednak ranę w innym miejscu. Dyrektor naukowy Mallinckrodt, Steven Romano, podkreśla, że zatwierdzenie StrataGraft to kamień milowy dla dziedziny medycyny zajmującej się leczeniem oparzeń.
– W ciągu ostatnich dwóch, trzech dekad było niewiele postępów w leczeniu tego typu oparzeń, dla których StrataGraft jest wskazany. Chirurdzy mają teraz do dyspozycji nową metodę leczenia, która pomoże zmniejszyć potrzebę stosowania autoprzeszczepów – dodał ekspert.
Źródło: FDA, medcitynews.com, Mallinckrodt Pharmaceuticals
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