Episode 9 | Stem Cell Revolution | Stem Cell Mixology
Description
In this episode of Stem Cell Revolution, hosts Donna Chang and Jan Shultis tackle one of the most misunderstood—but critical—FDA rules governing regenerative medicine: the “No Combination” clause. What happens when you mix stem cells with something else? A scaffold, a growth factor, or even a drug may seem like a harmless addition—but that single tweak could change everything.Donna and Jan unpack the FDA’s criteria for HCT/Ps under 21 CFR 1271, focusing on the third rule: no combination with other articles unless specifically allowed. With real-world examples and regulatory case studies, they explore how even well-intentioned innovations can push a treatment out of the HCT/P category and straight into drug regulation territory.From protecting patient safety to preserving innovation, this episode explores the fine line between regulation and overreach—and what it means for the future of cell-based 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 #StemCellTherapy #FDARegulations
United States
