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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Safety cannot be assessed by anecdotal evidence. I can find numerous stories of patients who died during routine, approved surgical procedures, it doesn't mean the procedure was unsafe.

Also, let's be careful about what we are talking about here. "Stem Cell treatment" is extremely broad. Cossu's studies, for example, are about mesoangioblast transplantation, which is far more elaborate and invasive than processes that have been used for more than 15 years for bone marrow-based treatments.

I'm simply wondering why autologous adipose stem cell therapy, where there is no manipulation of the stem cells (they are simply extracted from fat tissue and re-introduced into other tissues) is not considered a viable target for studies in DMD.

As far as I know there is a legal issue on autologous stem cells.

 

FDA says medicine. Practitioners say its like dialysis, returning to the body after purification.

 

15 years back FDA would have been justified in being careful. In todays world technology is safe enough to ensure that purified autologous stem cells are not harmful. As usual FDA is way behind the industry and think its their virtue to slow things down…probably they think they are being careful 

Tulika - that's what I thought too, but the FDA doesn't appear to be interested in legal action against these US companies which was my initial surprise.

And the more I learn about the adipose autologous process, I fail to see how it could be any less risky than a typical liposuction procedure:

1. Harvest stem cells via mini liposuction..a relatively safe procedure. Risks would include introduction of pathogens (infection) or blood loss. These risks are minimized by only harvesting cells from just below the dermal layer. Fat cells from which we derive the stem cells are just under the skin and typically we do not get near any large arteries or veins.
2. Follow strict sterile procedure to reduce the chance of infection.
3. Only reintroduce cells that were derived from your body so there is no chance of having an immune reaction that can be seen with introducing say organs from a donor.
4. Reintroduce your stem cells via injection, nasal spray, or IV. While there are minor risks with these procedure, the effects are minimal.

So from a procedural aspect this is a relatively routine procedure.

Surely the bottom line is efficacy - where is the peer reviewed proof from properly conducted and controlled studies, that it provides functional improvement of itself to our boys? I see a lot of this anecdotal stuff & marvel that blind Freddie can see the extra encouragement given & the extra training, the consumerism tricks of before & after photography and all the various other real psychological effects no doubt at work ...all of which account for the minimal improvement, if any. If a treatment really worked, don't you think PPMD would be backing it to the hilt? The world's parent projects aren't about careers or egos or amassing 6 figure salaries, expense accounts, company vehicles, incentives etc... the worlds Parent Projects by their various names are about strengthening our kids and prolonging their lives soonest. We've seen adverse reactions shut down avenues of research that would be promising if safety and caution was paramount. Why does everyone think they are 5 min experts & want to fall for all these sham therapies when it is obvious that PPMD and UPPMD with the worlds best minds on their scientific advisory boards are boy centred, family centred, holistic and maximizing every opportunity for quality of life and every opportunity for a cure and teaching us with quality educational events how to optimize our kids and our broken families. Beats me why a heap of us amateurs waste our brain cells on trying to get out heads around every therapy like bunch of bird-dogs chasing futilely after the next "flashy" object.

Deb, let me clarify it for you.  I try and wrap my brain around every therapy and opportunity because I owe it to my son.  I have spoken to doctors who are in charge of treating my son who dont have as much information as i do.  Currently I have a highly respected doctor in St. Louis who wants to start my 5 year old son on Lisinopril, the other doctor, Dr. Wong suggested we might think about this when he turns 8 or 9.  These are 2 women who have dedicated theii lives to this disease and completely disagree on basic standards of treatment.  This is why I will always stay informed and figure out the best course of action, because thats my job and you can't make an informed decision if you have no idea what they are talking about.  I love PPMD and have found it invaluable, but i will not put his fate in the hands, or minds, of one organization or individual.  PPMD is not the beginning and the end of that is DMD, other people and organizations have things to offer.  Just because PPMD is not funding this now does not mean it wont prove to be an effective treatment at some point.

Deb Robins said:

Surely the bottom line is efficacy - where is the peer reviewed proof from properly conducted and controlled studies, that it provides functional improvement of itself to our boys? I see a lot of this anecdotal stuff & marvel that blind Freddie can see the extra encouragement given & the extra training, the consumerism tricks of before & after photography and all the various other real psychological effects no doubt at work ...all of which account for the minimal improvement, if any. If a treatment really worked, don't you think PPMD would be backing it to the hilt? The world's parent projects aren't about careers or egos or amassing 6 figure salaries, expense accounts, company vehicles, incentives etc... the worlds Parent Projects by their various names are about strengthening our kids and prolonging their lives soonest. We've seen adverse reactions shut down avenues of research that would be promising if safety and caution was paramount. Why does everyone think they are 5 min experts & want to fall for all these sham therapies when it is obvious that PPMD and UPPMD with the worlds best minds on their scientific advisory boards are boy centred, family centred, holistic and maximizing every opportunity for quality of life and every opportunity for a cure and teaching us with quality educational events how to optimize our kids and our broken families. Beats me why a heap of us amateurs waste our brain cells on trying to get out heads around every therapy like bunch of bird-dogs chasing futilely after the next "flashy" object.

I do see where you're coming from as I've been doing the same thing for 20 years...but at the end of the day, what's worthwhile is funded by the UPPMD organizations and through experience and consultation, the BS is easily discerned. I wish I knew 20 years ago that only 5% any successful animal study will translate to humans at all. I wish I knew then that the spontaneous rate for DMD is actually 2/3 & not the 1/3 we were told. Doug was included in NY clinical trials despite living in outback Australia in the late 90's so we've followed more than one ray of hope, getting our own drug approvals etc. I knew families putting stem cells into their kids in the 90's, I know them now in the 3rd world & the result is going to be exactly the same until it is developed and proven -SFA. And non-profit politics - I could make your hair curl. All I'm saying is you may as well save yourself the angst - put your faith in those who have the purest motivations, for the best outcomes for all boys despite their particular mutation or age or circumstances and that's the best you can do for your son. On the heart and quality of life, we know that the earlier the better. We have children younger than 8 on lisinopril in Oz, but not many - Dr Wong knows what she is talking about. It has to be a good idea to delay heart muscle damage. By 15 yrs Doug's heart was not responsive to lisinopril but on a beta blocker he picked up 20% points within a couple of months building up the dose and has stayed at 68% for the past 10yrs on half the recommended dose for his weight. Heart meds have been well tested in all populations and will prevent the heart from becoming floppy and enlarged. All I'm saying after 20yrs of being faily proactive in this counter-culture is that if Pat Furlong and her peer group doesn't know about something, it isn't worth knowing about.

Deb - PPMD was built by parents, with same unrelenting curiosity. Nobody is suggesting to send their son to any such clinic blindly. These are just questions.

But I wonder why the two tiny words "stem cell" elicit such a reaction from so many, before they even look at the details. This isn't embryonic stem cells. This isn't experimental manipulation of stem cells. This isn't performed in a third-world clinic with questionable regulatory framework.

And I apologize, but this "bird dog" will continue chasing "flashy objects" so perhaps you can just ignore my posts.

What about Mayana Zatz in Brazil? 

She is a respected Dr. in the scientific community.

She works with stem cells.

Any opinions?

I have not had much luck learning anything new about Dr. Zatz's work since this post in 2011.

http://community.parentprojectmd.org/forum/topics/clinical-trial-wi...

This article discusses her plans to implement ALLOGENIC stem cell transplantation, where a tissue donor is used rather than the patient's own tissue. This carries greater risk of rejection than what clinics in the US are trying. It's not clear to me if her study was aimed at simple transplantation or if there would be some genetic modifications like what researchers at Univ of Minnesota are working on.

Hopefully her work is progressing and I'm just not hearing about it.

-David

Hi all, FYI, about Mayana Zatz, I contacted her by mail some time ago, she said she is plannig to start a pilot study with stem-cells from adipose tissue but I hasn´t set up a date yet . She said she doesn´t think it will be this year.

 

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