Just recently the Food and Drug Administration (FDA) has approved a private company’s (Antria) Phase 2 clinical trial study for the use of fat-derived stem cells in plastic surgery. These trials are set to begin within the next three months. Antria received approval for Phase 1 clinical trials just under two years ago in March 2013.
Antria is the first company in the world to obtain FDA approval for human studies for stem cell-assisted facial fat grafting study. Antria’s patent-pending process uses liposuction to extract the fat. Within one hour, stem cells can be prepared from that fat. Antria’s process uses its proprietary Adipolyx solution, a collagenase-based reagent, to isolate stem cells from adult fat cells.
While this FDA approval is significant in and of itself, the even greater relevance is what this indicates for the widespread marketing of so-called stem cell procedures in plastic surgery. The reality is that there are really no true stem cell procedures in plastic surgery despite what is claimed or promoted on the internet and otherwise. Procedures touted as ‘stem cell-enriched’, ‘stem cell injections’ or ‘stem cell procedures’ in plastic surgery are misleading.
While fat does contain numerous stem cells, these are inadvertent passengers in what is otherwise and simply put fat injections. Extracting fat by liposuction and concentrating it for injection for soft tissue augmentation does not make it a bone fide stem cell treatment. This is a marketing tactic, which although very appealing to patients, implies properties of the injection treatment that it does not have.
Fat injections have many benefits from adding soft tissue volume to improving the vascularity of the injected tissues. But whatever role the percentage of stem cells in the fat has in these benefits is highly speculative. That should not he confused with a highly concentrated and pure source of stem cells which is what is currently being studied in human clinical trials
Dr. Barry Eppley
Indianapolis, Indiana