Playing by the Rules: A Review of the Modern Regulatory Framework for Regenerative Medicine

This review provides the reader with an up-to-date summary of the U.S. regulatory framework as it relates to regenerative medicine therapies used in pain management. This includes relevant historical background, legal discussion, prevailing evidence for the discussed therapies, and expert opinion on potential pathways forward that promote safety alongside innovation.

Recent evidence in the regenerative medicine space supports the use of platelet rich plasma (PRP) for knee osteoarthritis, although findings are not uniform, with more limited data for bone marrow aspirate concentrate (BMAC) and adipose-derived products such as stromal vascular fraction (SVF). Perinatal tissue and exosomes show potential with early preclinical work. We gain valuable insight from warning notices and court rulings into how the FDA interprets guidance surrounding these therapies. With continued use and commercialization of regenerative medicine products for pain management, it is important to understand the regulatory aspects of these different therapies and how it may impact the day to day.