Cell stem cell · 2026
Development of human induced pluripotent stem cell-derived ovarian support cells as a clinical-grade product for in vitro fertilization.
СтатьяПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод в очереди
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Paulsen Bruna, Barrachina Ferran, Piechota Sabrina, Noblett Alexander D, Johnson Mark, Kats Simone, Lew Cassandra, Marchante Maria, Figueroa Alexandra B, Garcia Granada Itzel, Ingalls Lopez Elizabeth, Martinez Erick, Ricra Paula, Carlos Camila, Meza Jazmin, Montanchez Wendy, Pino Pilar, Reategui Cesar, Noriega Enrique, Elias Alicia, Noriega-Portella Luis, Haddad Gus, Radenkovic Dina, Moran Eugenia, Villanueva Pamela, Guiterrez Jose, Guzman Luis, Bortolleto Pietro, Albertini David F, De Vos Michel, Kramme Christian C
Аннотация
Human induced pluripotent stem cells (hiPSCs) show promise in the development of novel strategies to alleviate reproductive diseases and improve reproductive outcomes. Here, we detail the clinical development and application of an ovarian support cell (OSC) product, Fertilo, to improve the in vitro maturation (IVM) of human oocytes. First, we demonstrate that transcription factor-mediated hiPSC differentiation produces OSCs that improve the oocyte MII maturation rate. To support clinical application, we describe raw material upgrades and the generation of clinically suitable hiPSC seed and master cell banks, with transcriptomic analysis of resultant OSCs showing consistent and reproducible outcomes. Next, we detail analytical release testing and development of a murine oocyte maturation assay to assess product potency. Finally, application of Fertilo in a longitudinal cohort analysis shows improvement in key outcomes, compared with traditional IVM. Our findings demonstrate the first-time clinical development and application of an hiPSC-derived product to promote successful reproductive outcomes.