Development of human induced pluripotent stem cell-derived ovarian support cells as a clinical-grade product for in vitro fertilization
Year: 2026
Type: article
Abstract: 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.
Source: Cell stem cell
Authors: Bruna Paulsen, Ferran Barrachina, Sabrina Piechota, Alexander D. Noblett, Mark Johnson, Simone Kats, Cassandra Lew, Maria Marchante, Alexandra B. Figueroa, Itzel Garcia Granada, Elizabeth Ingalls Lopez, Erick Martinez, Paula Ricra, Camila Carlos, Jazmin Meza, Wendy Montanchez, Pilar Pino, Cesar Reategui, Enrique Noriega, Alicia Elias, Luis Noriega-Portella, Gus Haddad, Dina Radenkovic, Eugenia Moran, Pamela Villanueva, Jose Guiterrez, Luis Guzman, Pietro Bortolleto, David F. Albertini, Michel De Vos, Christian C. Kramme
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $10,400
OpenAlex ID: W7123890155