Leigh Turner and Paul Knoepfler recently published an important paper in Cell Stem Cell on stem cell clinics in the US. Turner is a University of Minnesota bioethicist and expert on medical tourism; Knoepfler is a stem cell professor at UC Davis who also runs a very well-regarded blog about stem cell research.
They identified 351 businesses, operating 570 clinics, all over the country. Some of these clinics may be offering services that do not require FDA approval, but in many cases, Knoepfler explained on his blog,
… there is a strong likelihood that FDA pre-approval would be needed because of issues such as non-homologous use and/or more than minimal manipulation. Such a large industry with unclear regulatory oversight and pre-approval is a big concern overall.
…[T]here are efforts to weaken the system of oversight. Senator Mark Kirk (R, Illinois) has introduced the REGROW Act (Reliable and Effective Growth for Regenerative Health Options that Improve Wellness), which is meant to speed up FDA approval for stem cell treatments. Knoepfler, who called a previous version of the bill “an attack on science-based stem cell trial oversight” remains skeptical:
it over-reaches so much that it would almost certainly do harm to patients and maybe to the stem cell field as a whole.ADVERTISEMENT
The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion and analysis. Read full, original post: The Direct-to-Consumer Stem Cell Industry in the US