Stem cell regulatory change in Texas, USA - real?

Can any parents in Texas vouch for this? Is this for real? If it is I can't believe I'm only just now noticing it.

http://blogs.nature.com/news/2012/04/texas-passes-stem-cell-regulat...

This regulatory change *appears* to blow the door wide open for treatments like in Texas like those you may have read about performed in Costa Rica, Panama; I'm thinking specifically about autologous stem them therapy.

Any Texas parents that can confirm this?

Is CellTex a real company? Are they as "shady" as the article implies?

-David

 

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Even if the company aint real the law is certainly there in place. Clearly defines that investigational products are those which have off label use, human cell based products and products pursuant to FDA approval.

The last point excites me more.

At least some folks will get the power to make an informed choice and not wait for a long process to complete.

Thanks for sharing this

A good synopsis of the controversy is here

http://www.minnpost.com/learning-curve/2012/03/celltex-controversy-...

CellTex is real for sure. They are clearly challenging federal law based on the notion that their process of stem cell extraction / processing does not qualify as a drug and thus not beholden to FDA authority.

(I can only imagine how happy Gov Perry would be if / when FDA brings legal challenge, what political theater!)

So it begs the question: Are there academics in Texas that are willing to walk this legal tightrope and make the request to their IRB for such a study?

 

 

David....from what you've read to this point, do you think this company is shady? I was under the impression that stem cells would need to be altered in some way to provide benefit in dmd. altering might then land them under the FDA guidelines.  Any more thoughts and insight on this from you would be helpful.
David said:

A good synopsis of the controversy is here

http://www.minnpost.com/learning-curve/2012/03/celltex-controversy-...

CellTex is real for sure. They are clearly challenging federal law based on the notion that their process of stem cell extraction / processing does not qualify as a drug and thus not beholden to FDA authority.

(I can only imagine how happy Gov Perry would be if / when FDA brings legal challenge, what political theater!)

So it begs the question: Are there academics in Texas that are willing to walk this legal tightrope and make the request to their IRB for such a study?

 

 

I really don't have an opinion on CellTex although clearly they are pushing the boundaries of medical ethics at the very least. Have they crossed the line? I really don't know. My own thoughts on bioethics have changed A LOT as my son declines.

Also, there are many different types of stem cell treatments, some which make major mods to cells, others that do not.

But the broader point is that if Texas is going to allow companies like CellTex to flourish, and the FDA doesn't rush in, that creates an environment in Texas that may finally bring some sincere studies involving treatments like what CellTex is doing. As long as CellTex operates in the dark, nobody learns anything.

But, with the feds quiet on the subject so far, will any docs or academics be so bold?

Some postings make it seem like a forgone conclusion that FDA will step in. Here is most pointed critique of the company and it has many more interesting links within it.

http://www.healthintheglobalvillage.com/?p=647

 

 

There are a couple of case studies of duchenne patients who received stem cell transplants for other indications that hint at benefit for duchenne.

Here's one kid that was DIAGNOSED with duchenne at age 12 - my point - who gets diagnosed at 12? The kid most likely benefitted from the transplant he got at age 1:

http://www.ncbi.nlm.nih.gov/pubmed/12235112

 

There are other case studies, but I can't find them now...

 

I've found that autologous adipose stem cell therapy, where patients own fat cells are extracted, "refined" and replaced, is not so rare in the US after all. That's a bit different than what Mindy posted in which another person donated bone-marrow stem cells.

I found another center in AZ that offers similar treatment than the company in TX.

http://www.the-stem-cell-center.com/about.html

Each visit is $8000. They are very careful with disclaimers that "this is not FDA-approved" treatment, but of course insist the treatment works miracles. I always thought this was unavailable in the US.

 

I'd watch this 60 Minutes peice before I spent one dime on a stem cell "treatment".  The world is full of people willing to make a buck off other people's despair.

http://www.cbsnews.com/video/watch/?id=7394380n



David said:

I've found that autologous adipose stem cell therapy, where patients own fat cells are extracted, "refined" and replaced, is not so rare in the US after all. That's a bit different than what Mindy posted in which another person donated bone-marrow stem cells.

I found another center in AZ that offers similar treatment than the company in TX.

http://www.the-stem-cell-center.com/about.html

Each visit is $8000. They are very careful with disclaimers that "this is not FDA-approved" treatment, but of course insist the treatment works miracles. I always thought this was unavailable in the US.

 

Good doco Keith. I'll use it. My community had a small local boy (not with DMD) but with severe learning difficulty after contracting a brain disease come back from China a few months ago after the community raised a huge sum to help him. Sure he is improving slightly and making small progress with his learningand speech but nobody is factoring in the intensive training and help he is getting now, or the normal process of repair or any number of effects outlined in R Barker Bausell's book, "Snake Oil Science". It is "working" but for all the wrong reasons & the unfortunate part is they could have chosen their snake oil more wisely - something far more economical and achieved the same result. After reading Barker's book, I don't buy into anything that is unpublished in reputable journal as I know the peer review is strenuous & even then there are caveats. It's a good volume for laypersons to understand medical research.

Let me be clear - I don't have any opinion on whether any of this actually works or if these companies are legit.

I posted the discussion because I had been told that such things were only overseas because Feds would never allow it, but now I know of at least two in the US, however legit they may be.

It does make you wonder why a 'reputable' study has not been started for DMD sufferers for what appears to be a safe process with broad possibilities.

Reputable study of stem cells for Duchenne is happening.  Dr. Cossu's work in Italy, for one.  I think PPMD even funded some of it. I know CureDuchenne did.  Dr. Calos at Stanford is another example.  I think MDA and the State of California funded that.

It may "appear" to be safe.  Here's a story about a patient in Florida that died during a stem cell treatment.  Maybe it's not so safe?  

 http://www.cnn.com/2012/03/08/health/stem-cell-doctor-suspension/in...

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