FDA Reaches to Regulate (i.e. Block) Simple Stem Cell Therapies

The FDA seems to be succeeding in the courts with regard to shutting down the few groups in the US trying to offer first generation stem cell therapies, and placing a heavy burden of regulation upon them. This most likely means that for another decade or so the only realistic way to access most of the present variety of stem cell therapies will continue to be medical tourism: "It's official: stem cells are drugs. At least, that's the opinion of the US district court in Washington DC, which has ruled that the Food and Drug Administration (FDA) has the authority to regulate clinics offering controversial stem cell therapies. Treatments in which stem cells are harvested from bone marrow and injected straight back into the same patient are deemed part of routine medical practice - not regulated by the US government. But if the cells are subjected to more than 'minimal manipulation', the FDA maintains that the therapy becomes a 'drug', which must be specifically approved for use. It was on this basis that in 2008 the FDA began moves to shut down Regenerative Sciences, a clinic in Broomfield, Colorado, that treats orthopaedic problems using a stem cell therapy called Regenexx. ... Regenexx consists of mesenchymal stem cells, which give rise to tissues including bone and cartilage, taken from a patient's bone marrow and grown in culture for about two weeks. Centeno has published a series of case reports describing its use to treat joint problems - but no controlled clinical trials. ... Regenerative Sciences challenged the FDA's authority to regulate its activities, setting the stage for a legal fight. In 2010, the FDA sought an injunction to take Regenexx off the market. This has now been granted in the court's ruling. Christopher Centeno, medical director of Regenerative Sciences, vows to appeal. 'This is really round one. Our position remains that a patient's cells are not drugs.'"

Link: http://www.newscientist.com/blogs/shortsharpscience/2012/07/ruling-frees-fda-to-crack-down.html


I wonder if this issue will reach the Supreme Court? It seems like an issue the Court might be willing to consider.

Posted by: Anthony at July 27th, 2012 12:53 PM

The FDA's only purpose is to protect windfall profits for drug companies,and it does that very effectively.

Posted by: Jay Hudson at July 28th, 2012 4:19 AM

I'm all for lax regulation of stem cell research/clinics. Still, it should be noted that some of these clinics are just snake oil salesmen who can't show their treatments actually help. (Case reports are anecdotal evidence.) Until the science matures in a few years, they should be an option of last resort.

Posted by: k at July 30th, 2012 1:21 PM

I wrote a blog post about this today, "Why We Need Medships" (http://thinkingmachineblog.wordpress.com/2012/08/03/why-we-need-medships/). As Reason pointed out, one way to bypass FDA rulings is via medical tourism. However, I realized that a combination of medical tourism + blueseed (http://www.blueseed.co/) = medships. The basic idea is to emulate blueseed by parking a cruise ship outside of the 12 mile limit on the coast of a given country, let us suppose the US. As such, the ship would not be subject to US laws and only a tourist visa would be required for anyone going to the ship via the US. Otherwise, going to the ship directly would not require a visa. The medship would be able to host innovative medical research while being near the amenities of technology, medical expertise, etc. of a large coastal city. Please see my blog for a more detailed discussion.

Posted by: Augustus Van Dusen at August 3rd, 2012 3:48 AM

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