Update on a US Autologous Stem Cell Therapy Trial

It is only in the last couple of years that clinical trials have started for autologous stem cell therapies in the US. Or, to put it another way, for some time now unelected and largely unaccountable employees of the US government have forbidden US residents - on pain of criminal prosecution - from offering or making their own decisions about a medical technology commercially available elsewhere in the world. All the while, these bureaucrats impose vast costs on medical development concerns by insisting on largely pointless trials, continuing far past any reasonable trade-off between risk and reward, thereby greatly postponing the commercial introduction of these technologies in the US.

Do you have responsibility for, or even the ability to make your own medical choices? Not according to people in positions of power at the FDA. Regulation in medicine has largely become an exercise undertaken for its own sake, as is the end result of any centralization of power. No-one's interests are being served save for those of the career bureaucrats in charge of forbidding new things. Everyone else gets to suffer due to the ball and chain shackled to medical progress, and due to being forbidden the basic, fundamental freedom to choose how to treat their own medical conditions.

But back to the science, what little of it is presently permitted to proceed.

An autologous therapy is one in which stem cells are taken from the patient, multiplied many times over in cell cultures, and then returned en mass to spur regeneration that the body would normally not accomplish on its own. Here, Scientific American updates us on an ongoing trial:

The first person to receive a new cardiac stem cell treatment in a U.S. Food and Drug Administration clinical trial is doing well, it was announced last week. ... Jones, whose heart tissue is permanently scarred and weakened by two previous heart attacks, suffers from congestive heart failure

...

The new approach, using a patient's adult stem cells to regenerate healthy heart tissue, is currently in phase I clinical trials to test for safety. The procedure consists of removing healthy heart tissue from the patient, purifying the stem cells from the material, and allowing the stem cell population to grow. Once ready, the stem cells are reintroduced into the scarred region of the heart using a minimally invasive technique.

Since the re-injection of his own stem cells on July 17, Jones' heart has increased its ability to pump blood by about 5 percent. Jones commented in the University of Louisville School of Medicine press release that he felt so good he might "even start jogging again."

The doctors will continue monitoring Jones every few months for the next two years to measure his recovery. There are currently 13 more patients going through the phase I trial, and the researchers hope to eventually test a total of 20 patients.

Now ask yourself, why can't anyone with heart disease and the necessary funds just up and do the research on the treatment and choose to try this within the borders of the US? Because a faceless bureaucrat has decided that it is forbidden, and that anyone who offers this treatment must be jailed. Welcome to the land of the free.

Comments

Quite right...it is very sad that the US is so far behind the rest of the world in stem cell treatments.

To make matters worse, they are now bragging about being the first? Wow. Such audacity...or ignorance?

For the record, he is not the first. Not even close. In fact...

1. There have been MANY clinical trials in the US prior to this one (why has the mainstream media ignored them?).
2. Adult Stem Cells have been used to treat cardiac disease around the world for 5 years.

Here's the proof:
http://repairstemcell.wordpress.com/2009/07/29/first-ever-stem-cell-heart-patient/

Posted by: David Granovsky at July 29th, 2009 9:42 AM

We have simply lost our spirit of innovation and let belief come before fact. To those of you wishing to start over here in the US, a word of advice... Look elsewhere

Posted by: Ken Geiger at May 10th, 2010 3:25 PM

I suspect that the "people" making these decisions for the rest of us have NEVER faced debilitating conditions such as those treated by Stem Cell Therapy. I'd give them just one week with my 3 auto-immune diseases to change their minds about what options should be made available to us.

Posted by: Brianne at June 7th, 2011 10:27 AM

The pharmaceutical companies care only about their profits, they sponsor the campaigns of top-politicians and they are rewarded by the political elite for their contributions. That's, in essence a plutocratic system. Why would profit and power-driven companies want to cure the disease? They want to sell a product that they have monopoly on which helps with the symptoms so that the people come back and buy more product, until they die. That is the ideal situation from the Big Pharmas stockholders perspective. A healthy public is a threat to Big Pharma's owners and investors. Stem cell therapy has the potential to actually cure what Big Pharma only wants to have monopoly of managing with their product. This is all beyond public control, public is excluded from the decision making processes, politicians are looking after the interests of their rich Big Pharma sponsors and the public continues to suffer. Is this the kind of system that we want to have? If yes, then fine go ahead and buy and eat Prozac and watch American idol. If no, then we should work to change it by organising, coming together discussing and taking action to build a decent society.

Thanks you!

Posted by: Noah at June 11th, 2011 2:18 PM

This summer, 2011, I ran into a gentleman whose brother is a Doctor at Duke University. He made arrangements for him to harvest his own stem cells just prior to undergoing chemo for his Lymphoma.
The doctor not only got his stem cells harvested prior to his Chemotherapy, but glory be to God, his insurance company paid for it to be done. He was told that on their own , they will keep reproducing the rest of his life, the stem cells, so that if anything goes awry in his body, it will AUTOMATICALLY seek out and repair, or destroy the invaders or the condition that needs healing, such as either myeline sheath being lost or a cut on his finger.
He was also told he'll probably live quite awhile.
Now WHY IN h_ _ _ aren't we hearing more of these treatments? This man had a kerchief on his head still from his hair loss and they released him from the hospital 5 days after the procedure, because the blood samples taken showed they new stem cells were ALREADY doing a great job of proliferating on their own !!
I'm not kidding......there is something seriously wrong with people in our country who do not react to this.
Let us get together and gather forces! I am beginning to believe now in "Prozac Nation" if we don't do this.What drug is everyone on???

Posted by: Anne at October 25th, 2011 4:38 PM

I wonder if stem cells would work to improve sexual health where anti- depressants have hurt it. It might be the answer to many problems in the psychological world.

Posted by: Bruce at October 22nd, 2012 10:01 AM
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