Gameto, a clinical-stage biotech company developing iPSC-based therapies for women’s health, announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for Fertilo, to enable the launch of the first US-based Phase 3 clinical trial for an induced pluripotent stem cell (iPSC)-based therapy.
One of REPROCELL’s StemRNA™ Clinical Seed iPSC Clones was utilized to engineer ovarian support cells (OSCs) with high purity and potency. These OSCs mimic the natural ovarian environment in a dish, providing the essential support needed for egg maturation ex vivo.
“I am very pleased that Gameto has obtained FDA IND clearance for Fertilo, which utilizes our StemRNA™ Clinical Seed iPSC. This achievement is proof that our Clinical Seed iPSC Clones are a high-quality cell product that meets the stringent regulatory standards of various countries. I am confident that it represents a significant step toward facilitating innovative therapies in the field of regenerative medicine. We will continue to strive for technological advancements and ensure safety as we contribute to the development of regenerative medicine programs worldwide.” said Dr. Chikafumi Yokoyama, CEO of REPROCELL Inc.
StemRNA™ Clinical Seed iPSC Clones are manufactured in compliance with the standards established by the US FDA, the European EMA, and Japan’s PMDA and generated using REPROCELL’s proprietary highly safe RNA reprogramming technology. Multiple-donor clones are available for evaluation as off-the-shelf lines, or we can generate exclusive lines to suit your specific project needs.
For more information regarding StemRNA™ Clinical Seed iPSC, visit:
https://www.reprocell.com/clinical-stem-cell-services/gmp-ipsc-production
For frequently asked questions (FAQs) about StemRNA™ Clinical Seed iPSCs, visit:
https://www.reprocell.com/clinical-stem-cell-services/faq-ipscs