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Doctors Skirt FDA To Heal Patients With Stem Cells
kkleiner writes "For many years countless individuals in the US have had to watch with envy as dogs and horses with joint and bone injuries have been cured with stem cell procedures that the FDA has refused to approve for humans. Now, in an exciting development, Regenerative Sciences Inc. in Colorado has found a way to skirt the FDA and provide these same stem cell treatments to humans. The results have been stunning, allowing many patients to walk or run who have not been able to do so for years. There's no surgery required, just a needle to extract and then re-inject the cells where they are needed. There has always been a lot of hype around stem cells, but this is the real deal. Real humans are getting real treatment that works, and we should all hope that more companies will begin offering this procedure in other states soon."
Also hard to tell if this doc is just another snake oil salesman or is God's Gift to Medicine. FTFA:
Right. Must be stem cells. Couldn't possibly be natural healing of an acute injury - which is exactly what it looks like. Seems to be a T1 weighted image which shows localized edema. Wait awhile and magically the body heals itself. Take another MRI and profit!
Nice thing about bypassing the FDA - you don't have to prove safety or efficacy. Just take people's money.
Faster! Faster! Faster would be better!
Just in case you were asking a serious question, and not looking to insert a South Park reference...
These are autologous stem cells (meaning YOUR OWN). No harvesting from anyone other than you.
They harvest a small amount of your own bone marrow, extract the stem cells from it, and inject them into the spots where they are needed.
Having said all that, this is a really glowing report that claims to be taking a harsh look at the company, then uses testimonials and reference materials from their own web site to "prove" it. It may be legit, but I smell just the faintest tang of green-colored artificial grass product.
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I can't speak to the medical benefits/drawbacks of stem cell therapies as I am not a doctor. However, I have to say that the attitude and gumption displayed by Dr. Centeno in his field is inspiring. Despite all the legal bullshittery and political asshatting going on around the country with regards to stem cell therapy, he managed to pioneer forward, develop some techniques and facilities, and find enough of a technicality to bring an actual treatment to his actual patients. That's a classic American cowboy attitude on display right there. He didn't let his exhaustion or cynicism get him down. He pioneered and worked hard and now ~80% of his patients are reaping the benefits. I have to say, that is very inspiring.
Folk like Dr. Centeno deserve a lot of recognition and thanks. I, for one, wish him luck. As soon as the blood-sucking lawyers get ahold of him, he's going to need it.
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As a biomedical researcher, I'm glad to finally see some of the promises of stem cells. However, this must be tempered by knowing that there exists a fine line between stem cells and cancer cells. Both grow outside of the normal controls that keep excess cell division in check. For stem cells, this is developmentally controlled by the neighboring cells. I wonder how these stem cells will respond when moved to a new environment and what the long term effects will be. I guess that FDA sanctioned or not, we're going to find out.
"Me fail English, that's unpossible." --Ralphie
Real safety testing is very, very difficult to do in a controlled way.
The only way to test on humans is to actually test on humans. People are always willing to take a risk when they are living with constant pain, as are these people. I wonder if the real culprit on the delay is the insurance companies? Or is it the established medical community who are not tooled up yet for maximum profit on the procedure?
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"These are autologous stem cells (meaning YOUR OWN). No harvesting from anyone other than you."
And, finally, we come to the heart of the matter.
TFA states: "The FDA seems to have taken the stance that all stem cells (whether used autologously or not) are drugs."
THIS is what is at issue here. The good Doctor is simply forcing the FDA into a position to either back down from that assertion or validate it somehow. He is forcing debate on the issue.
Just what, exactly, constitutes a drug. The Doctor argues that this is a "treatment" or "therapy", no different then a skin-graft or banking your own blood supply, and he makes a valid point. The actual substance used is from the body it came from. Did it become a "drug" simply by removal from the patient's body?
MASSIVE amounts of money are on the line here, especially if the very definition of the term "drug" is altered as a result as it would also alter the markets associated with drugs. The BigPharma are already trying (and succeeding) in getting patents for stuff that we ALL already possess, and seek to make a profit from those patents.
Who, exactly, do you think their competition will be in this market? Who ELSE might be able to supply YOU with the stem cells needed for such treatments? You! The only viable means the Pharma have to compete is growing their own supply and then make it harder to use your own cells. Enter the Lobbyists and FDA Guideline Revisionists.
I hope the good Doctor has good lawyers.