[ExI] U.S. District Court rules that stem cells are drugs

James Clement clementlawyer at gmail.com
Thu Jul 26 14:14:49 UTC 2012

This is very disappointing news, since it means that the safest and
potentially most effective regenerative medical treatment we have
(autologous stem cells) is now going to be virtually impossible to pursue
in the U.S. (at least as long as this court decision hasn't been
overturned). I guess this shouldn't be a surprise, however, since there's
so much money to be made by Big Pharma for one-size-fits-all, allogeneic
stem cell treatments.. This obviously makes the even more desirable
treatment, doing gene therapy on autologous stem cells before returning
them to one's body, even more unlikely in the near future.

What's the status of autologous stem cell treatments in other parts of the

Best regards,


U.S. District Court rules that stem cells are drugs

Krista Conger on July 25th, 2012 1 Comment

Peter Aldhous from New Scientist reports today that the U.S. District Court
in Washington, DC, has ruled that a person’s own cultured stem cells are
drugs subject to regulation by the Food and Drug Administration.

This is a big deal, as it’s the cornerstone of an ongoing argument between
the agency and Colorado-based Regenerative Sciences (The FDA Law Blog
summarized the legal tussles nicely last October). It’s also germane to the
issues surrounding Texas-based Celltex, which I’ve blogged about before.

According to Aldhous:

It’s official: stem cells are drugs. At least, that’s the opinion of the
[court]… which has ruled that the Food and Drug Administration (FDA) has
the authority to regulate clinics offering controversial stem cell

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.

Aldhous also quotes Regenerative Sciences’ medical director Christopher
Centeno, MD, vowing to appeal the ruling, as well as Stanford’s own
Christopher Scott:

“I think it’s a good ruling, and I’m glad to see that that the FDA has
exercised its muscle on the case,” says Christopher Scott, who heads the
Program on Stem Cells in Society at Stanford University in California.

Scott hopes that the FDA will now step up its efforts to regulate other
clinics offering unproven stem cell therapies. These include Celltex of
Sugar Land, Texas, which rose to prominence after Texas governor Rick Perry
was injected with stem cells supplied by the company to aid his recovery
from back surgery.

This is obviously not the last of the story– we’ll keep you posted.
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