Christian Kramme: Advancements in Stem Cell Technology Transforming Fertility Care
Christian Kramme, Chief Scientific Officer at Gameto, shared a post on LinkedIn about a paper published in Cell Stem Cell:
“Excited to announce Gameto’s newest study has been published in the Cell Press journal Cell Stem Cell. This work describes the translational activities that enabled our product Fertilo to become the first human induced pluripotent stem cell (iPSC) derived product in history to receive IND clearance with the FDA to enter a Phase 3 Clinical Trial in the United States, the first to enter Phase 3 using a transcription factor-directed differentiation approach, and the first iPSC-derived product to be utilized in phased clinical trials in IVF. Just as importantly, this work describes our First In Human clinical study of Fertilo, reporting not only our embryological outcomes but also our clinical pregnancy outcomes and live births in infertility patients. I believe this work serves as a foundational dataset for understanding the manufacturing, quality, analytical release and clinical use processes of Fertilo by demonstrating the proof of concept to clinical treatment path we took as a company. I hope that the methods and approaches we leveraged here can also help others in the field of cell therapy and iPSC technologies chart a path to clinical translation to bring these important medicines to patients.
Thank you so much to all of our clinical collaborators at Concebir – Centro de fertilidad and Fertilidad Integral, our manufacturing and analytical release partners at Embryotools S.L. and GENEWIZ from Azenta Life Sciences and our clinical advisors and collaborators Michel De Vos, Pietro Bortoletto, and David Albertini. Thank you as well to the incredible scientists at Gameto that spearheaded this work, Bruna Paulsen, Ferran Barrachina, Mark Johnson, Sabrina Piechota, Alexander Noblett, and so many others. Thank you as well to my fellow leardership team at Gameto who design and steer our clinical use programs Dina Radenkovic Turner and Gus Haddad and our scientific advisors George Church, Kristin Baldwin, Pranam Chatterjee, Matthew ‘Tex’ VerMilyea, Jaime Knopman and Philip Jordan.
Please give the work a read, learn more about Gameto, and our ongoing trial in the US!
Link to paper.”
Title: Development of human induced pluripotent stem cell-derived ovarian support cells as a clinical-grade product for in vitro fertilization
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, Christian C. Kramme
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