

First Stem Cell-Based Therapy Gets Approved – In Canada - plessthanpt05
http://singularityhub.com/2012/05/30/first-stem-cell-based-therapy-gets-approved-%E2%80%93-in-canada/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed:+SingularityHub+(Singularity+Hub)

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reasonattlm
And absent the FDA, first generation therapies based on stem cell transplants
would have been available in the US for much of the past decade, and we'd have
had a few years of second generation therapies devoted to small patient
populations like this one.

Meanwhile, the large patient populations (e.g. heart disease) continue to have
to leave the country to find stem cell therapies. The FDA makes it
prohibitively expensive to develop therapies, steps on groups that try to
offer stem cell treatments akin to those widely available elsewhere in the
world, and thus encourages a black market:

[http://www.fightaging.org/archives/2011/11/an-unusually-
clea...](http://www.fightaging.org/archives/2011/11/an-unusually-clear-
example-of-the-cost-of-the-fda.php)

[http://www.fightaging.org/archives/2011/12/when-you-make-
med...](http://www.fightaging.org/archives/2011/12/when-you-make-medical-
progress-illegal-what-results-is-a-black-market-in-medical-progress.php)

[http://www.fightaging.org/archives/2012/01/research-and-
clin...](http://www.fightaging.org/archives/2012/01/research-and-clinical-
development-industries-in-the-us-must-start-to-extend-beyond-the-us.php)

[http://www.fightaging.org/archives/2010/08/fda-tries-to-
shut...](http://www.fightaging.org/archives/2010/08/fda-tries-to-shut-down-
regenerative-sciences.php)

Regenerative Sciences, Inc., a Colorado medical practice that specializes in
the use of a person's own stem cells to help patients avoid more invasive
orthopedic surgery, announced today that the US Food and Drug Administration
(FDA) is seeking to enjoin the clinic physicians from practicing medicine
using patients' own stem cells. The lawsuit will allow Regenerative Sciences
to question the FDA's policy that adult stem cells can be classified as drugs
when used as part of a medical practice. ... The FDA will finally answer our
questions, in court, about their claims and jurisdiction as opposed to doing
everything in their power to avoid the issue that we are not a drug
manufacturer, but simply a medical practice.

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sp332
This is mentioned in the article. _So why does a company based in Dulles, VA
have to go to Canada to get approval? Well, as promising the results are, they
no doubt are surprising to some. In 2009 Prochymal suffered a major setback as
two separate trials showed that, while the drug was safe, it failed to improve
the condition of patients with graft-versus-host disease._ This treatment was
shown twice to be ineffective, and therefore not worth the risk of injecting
yourself with an experimental batch of processed stem cells. Also, _even with
the failed 2009 trials, the FDA isn’t dragging its feet. Prochymal is
currently being tested in trials that will assess, not only its ability to
mitigate graft-versus-host disease, but Crohn’s Disease as well._

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adventureful
What's really disturbing is that the FDA has flunked Prochymal twice now (if
I'm recalling correctly). Which is why Osiris went to Canada to get an
approval, hoping to demonstrate safety and push it globally, as it's still an
X factor whether the treatment will ever make it past the FDA.

Osiris even has the Pentagon / DoD in their corner (and had Genzyme as their
partner for a long time to boot), as Prochymal is being developed under a
government contract to treat skin radiation burns and similar. If you can't
get a drug through with those boosters.......

~~~
sp332
It was proved safe in the US trials. It was also proved _ineffective_ twice.
That's why the FDA "flunked" it.

~~~
ams6110
_Patients were given infusions twice a week for four weeks. Soon after first
infusion, 63 percent showed a “clinically meaningful” response (no further
details)._

I am pretty sure that in drug trials, "clinically meaningful" just means it's
measurable beyond the threshold of statistical noise; it does NOT mean a what
most people would think of as a meaningful or marked improvement in the
patient's condition

