REPROCELL’s StemRNA™ Clinical Seed Clone VCT-37-F35 Supports a Phase 3 Fertility Therapy

Gameto’s Fertilo program uses iPSC-derived ovarian support cells to mature eggs outside the body as part of their next-generation IVF technology.

REPROCELL’s StemRNA™ Clinical Seed Clone VCT-37-F35 (Female, 23, Caucasian, Healthy, A+) served as the starting iPSC source for the program.

High-Quality iPSCs: The Foundation for Clinical Therapy 

Developing an iPSC-based clinical therapy requires starting cells that support:

 •  Clinical manufacturing workflows

 •  Reproducible differentiation into therapeutic cell types

 •  Regulatory documentation suitable for clinical programs 

For Fertilo, the goal was to generate ovarian support cells (OSCs) from iPSCs that could replicate the natural ovarian environment and support egg maturation outside the body.

Key elements of the workflow:

 • REPROCELL's seed clone was generated using non-integrative mRNA reprogramming technology

 • Manufactured following GMP principles at REPROCELL's Japan GMP facility, and supplied via REPROCELL USA.

 • Used to generate clinical seed banks and master cell banks

 • Differentiated into ovarian support cells (OSC) for Fertilo development

This approach provides a clinically qualified starting point for cell therapy development.

From First Live Birth to FDA-Cleared Phase 3 Trial

The in vitro oocyte maturation technology helped enable the world’s first live birth using Fertilo, demonstrating the clinical potential of iPSC-derived cells in reproductive medicine. 

Fertilo received FDA IND clearance, enabling the first Phase 3 clinical trial in the U.S. for an iPSC-based therapy.