In this episode of Stem Cell Revolution, hosts Donna Chang and Jan Shultis take listeners on a journey into the final—and perhaps most complex—criteria of the FDA’s HCT/P framework: systemic effect and the metabolic activity of living cells. Inspired by a recent trip to Disney World, Donna returns with fresh perspective (and a little pixie dust) to explore how the magic of stem cell science often runs into the reality of regulation.While the idea of cells working throughout the body to repair and restore sounds like science fiction come true, the FDA sees it differently. When stem cell therapies have systemic effects or rely on living cells to function, they cross the line into biologic drug territory—bringing with them a world of regulatory hurdles.Through compelling case studies and deep scientific discussion, Donna and Jan break down what counts as a systemic effect, how metabolic activity is interpreted by the FDA, and why some therapies are exempt—like autologous use and reproductive applications. They also explore the gray areas of cytokine secretion, paracrine signaling, and what truly defines a “local” effect.From clinics that crossed the line and got flagged to industry calls for reform, this episode sheds light on where the field stands—and where it’s headed. Whether you’re a researcher, policymaker, or patient advocate, this episode offers a thoughtful, imaginative look at how we balance innovation with oversight in regenerative medicine.Join the Conversation:Your feedback is crucial! Ask us anything in the comments about stem cell therapies and their regulation, or share your experiences.Don't forget to like, subscribe, and hit the bell icon for more updates on stem cell research and its revolutionary potential in healthcare. Links:HOPE STORE: https://www.hope.bio/merchWEBSITE - https://www.hope.bioINSTAGRAM - / hope.bioTWITTER - / hopebiosciencesFACEBOOK - / hopebiosciences#StemCellRevolution #RegenerativeMedicine #FDA #StemCells #HCTP #Biologics #SystemicEffect #ScienceWithMagic