Founder & CSO RenewalBio Rehovot, HaMerkaz, Israel
Abstract: Since the discovery of induced pluripotent stem cells (iPSCs) in 2006 and their first clinical application in 2014, progress in the development of iPSC-based therapeutic agents has been relatively modest, with iPSC-derived products only being administered to humans for approximately 7–8 years, yet any of them are clinically approved. This limited advancement is largely attributed to challenges in directed in vitro differentiation protocols, genomic instability, vague target cell identity, and poor engraftment. RenewalBios’ platform utilizes innovative 3D human developmental models, termed "stembroids," derived from iPSCs. This groundbreaking approach is based on three patented technologies: First, a unique naïve media composition enabling enhanced differentiation plasticity, allowing iPSCs to generate not only the three germ layers but also extraembryonic tissues. Second, the stembroid generation process creates developmental models by aggregating iPSCs, their derivative placental, and yolk sac precursor cells, providing optimal conditions for proper differentiation while avoiding ethical obstacles associated with real embryos. Third, a specialized ex-utero culture device supports natural development and differentiation of genuine cell types by providing the optimal physiological and mechanical conditions. Together, these technologies establish a robust and unique platform for generating authentic, and functional cells for various therapeutic applications. The stembroid platform represents a holistic and multifaceted approach to cell therapy. Unlike traditional unilateral methods, a single stembroid protocol can yield various cell types, significantly enhancing cost-effectiveness and enabling the efficient production of multiple target cell types. This versatility, combined with improved authenticity and functionality, positions RenewalBios' platform as a superior alternative to conventional in vitro differentiation methods.
