This past week, a new commentary paper on unregulated stem cell clinics made headlines throughout the media: Dr. Leigh Turner, an Associate Professor in the Center for Bioethics, School of Public Health, and College of Pharmacy at the University of Minnesota and Dr. Paul Knoepfler from the University of California Davis, authored a thinkpaper, published online in Cell Stem Cell, which analyzes the current state of the stem cell clinic market in the USA.
Titled “Selling Stem Cells in the USA: Assessing the Direct-to-Consumer Industry,” the paper identifies
351 U.S. businesses engaged in direct-to-consumer marketing of stem cell treatment across 570 clinics. The hotspots for these businesses were identified as Los Angeles (particularly Beverly Hills) and New York, while metro areas of Miami, Denver and Dallas-Fort Worth were also described as “high density” with respect to stem cell clinics.
4 out of 5 of the businesses, the paper further found, administered autologous therapies, with 61% of those marketing adipose tissue-based treatments. Only one of the businesses was found to advertise what it claimed are induced pluripotent stem cells, but the authors could not determine further information about things such as source and type of these pluripotent stem cells.
The authors took particular issue with the claims that these clinics are making with regard to the treatments they are administering – many of which being quite liberal in their claims – mentioning that ethical, legal and safety concerns may be at play.
The question of stem cell clinics has been an issue brought up previously, with organizations such as ISSCR dedicating a session during their 2015 Annual Meeting to the topic, and this paper won’t be the last analysis that we will see.
It is, nonetheless, clear that a highly active field of clinics is thriving on the back of questionably proven stem cell treatments, operating without clear regulatory oversight. Arguments exist from both side of the fence, however, with proponents of deregulation, claims the paper, blaming the strict regulatory landscape that has resulted in too few approved treatments.
As we continue to support peer-reviewed, validated and standardized processes, this market will be interesting to follow.