FDA Regulation of Human Cells, Tissues and Cellular and Tissue-Based Products

Stem cells have ability to differentiate into numerous cells upon various stimulations. This has led to their wide utilization across several therapeutic areas of medicine, including high risk diseases. Of course, significant scientific breakthroughs in the use of stem cells to prevent, diagnose, and treat numerous diseases has caused numerous start-up companies to form. Despite, such promise, the FDA has yet to approve stem cell therapies for a wide range of diseases, except cord blood-derived hematopoietic progenitor cells for certain indications.

This session will provide an historical context for the use of stem cells in medicine, where the field has been and where it is going. FDA's regulations and policies updates for regenerative medicine including stem cell treatments, tissue engineering and gene therapies will be reviewed as well as updates on policies regarding regenerative combination products and devices. It will also provide the few examples of FDA approved use of stem cells in medicine and what is needed for the field to progress and practical solutions for staying compliant and avoid FDA warning letters during audit.