Proizvodnja i upotreba humanih mezenhimskih stromalnih ćelija izolovanih iz placente za klinička istraživanja prve faze: uspostavljanje i procena protokola
Sažetak
Uvod/Cilj. Mezenhimske matične (stromalne) ćelije (MSCs) trenutno se koriste u velikom broju kliničkih istraživanja za različite kliničke indikacije. Iako je koštana srž uobičajeni izvor početnog materijala za kultivaciju ovih ćelija, količina ćelija koja se pri tome dobija i dalje predstavlja ograničavajući faktor. Alternativno, MSCs sve više se izoluju iz drugih tkiva kao što su placenta novorođenih beba ili masno tkivo. U inicijalnom istraživanju nije otkrivena nikakva razlika u osnovnim fenotipskim karakteristikama ćelijskih receptora, hemokinskih receptora ili sposobnosti ćelija za normalnu mezodermsku diferencijaciju između MSCs izolovanih iz placente i koštane srži. Cilj ovog rada bio je uspostavljanje i procena protokola za kultivaciju i odabir MSCs izolovanih iz placente i adekvatno pripremljenih za upotrebu u kliničkim istraživanjima prve faze. Metode. U ovoj studiji korišćena je placenta beba rođenih carskim rezom nakon normalne trudnoće. Izolacija, zasejavanje, inkubacija, krioprezervacija i kriterijumi za proizvodnju humanih MSCs bili su u skladu sa složenim regulatornim principima koji se u ovom trenutku primenjuju u Australiji. Rezultati. Uspostavljen je i procenjen detaljan protokol za pripremu MSCs i dat je pregled njihove upotrebe u tri različite kliničke studije. U prvoj studiji MSCs su date iv putem, pre alogene transplantacije matičnih ćelija krvi, u lečenju akutne mijeloidne leukemije refraktorne na terapiju. U drugoj studiji, MSCs su date iv u lečenju idiopatske fibroze pluća, bez ozbiljnih neželjenih efekata. U trećoj studiji, MSCs su injektovane direktno u mesto oštećenja tetive pod kontrolom ultrazvuka, u lečenju hronične refraktorne tendinopatije. Zaključak. Kliničke studije, bazirane na primeni ćelija alogenog i autolognog porekla, demonstrirale su bezbednu upotrebu MSCs. Prikazani protokol je pogodan za rane faze kliničkih istraživanja, relativno je pristupačan i može se lako prilagoditi različitim kliničkim uslovima i zakonskim regulativama.
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