Making Sense of Stem Cells and Fat Grafting in Plastic Surgery: The Hype, Evidence, and Evolving U.S. Food and Drug Administration Regulations.

Autologous fat grafting and adipose-derived stem cells are two distinct entities with two different risk profiles, and should be regulated as such. Autologous fat grafting prepared with the additional step of stromal vascular fraction isolation is considered a form of "stem cell therapy" given the high concentration of stem cells found in stromal vascular fraction. Much ambiguity existed in the distinction between autologous fat grafting and stromal vascular fraction initially, in terms of both their biological properties and how they should be regulated. The market has capitalized on this in the past decade to sell unproven "stem cell" therapies to unknowing consumers while exploiting the regulatory liberties of traditional fat grafting. This led to a Draft Guidance from the U.S. Food and Drug Administration in 2014 proposing stricter regulations on fat grafting in general, which in turn elicited a response from plastic surgeons, who have safely used autologous fat grafting in the clinical setting for over a century. After a series of discussions, the U.S. Food and Drug Administration released its Final Guidance in November of 2017, which established clear distinctions between autologous fat grafting and stromal vascular fraction and their separate regulations. By educating ourselves on the U.S. Food and Drug Administration's final stance on fat grafting and stem cell therapy, we can learn how to navigate the regulatory waters for the two entities and implement their clinical use in a responsible and informed manner.