• Regulatory frameworks for stem cell therapies vary significantly across regions, with the EU and Switzerland prioritizing safety and ethics, while the US adopts a more flexible approach, impacting innovation and clinical translation.
• Clinical trials involving iPSCs have grown substantially since 2008, with a focus on cardiovascular and nervous system conditions, highlighting the therapeutic potential of iPSCs.
• Countries with more flexible regulatory guidelines, such as the US and Japan, lead in the number of stem cell clinical trials, whereas EU countries lag due to stringent regulations.
• The study advocates for global regulatory convergence to balance safety and innovation, facilitating international collaboration and efficient advancement of stem cell therapies.