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Julie  Stachowiak, Ph.D.

First US CCSVI Treatment Study Planned

By March 30, 2010

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Rumors have been swirling around chronic cerebrospinal venous insufficiency (CCSVI) studies and treatment opportunities since news of the theory hit mainstream media in late 2009. Most recently, I have heard that new study centers have been opened up and others have closed their doors, but have found it very difficult to verify most of this information.

Here is one that is easily verifiable, as it is now posted on the Clinical Trials Database (as of March 29, 2010): Study to Evaluate Treating Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Multiple Sclerosis Patients.

Being run by The Vascular Group, PLLC in Albany, NY, this is an interventional trial designed to test safety and efficacy of angioplasty procedures in 500 patients found to have at least 50 percent stenosis of the extracranial central veins. Interestingly, "safety" as a primary endpoint is defined as "as the incidence of major adverse events at 30 days following the index procedure," and feasibility and efficacy are "determined by those patients that do not have more than 50 percent restenosis within the 30 day time frame."

I'll let you read the rest for yourselves by clicking on the link to the study above (which includes contact information for investigators).

The one thing that I will mention is that the inclusion and exclusion criteria are extremely broad (basically including anyone with MS older than 18 who agrees to the followup), coming down to one possible sticky moment: the person must have presence of greater than or equal to 50 percent stenosis of the extracranial veins as determined by venogram. It will be interesting to see how many people qualify for this trial, based on these criteria.

Again, this is the only trial that I could find concrete information about at this time. Please add any info about other trials that you might have to the comments section below.

PS For any Canadians who have received treatment at Hamilton's MS clinic at McMaster University Medical Centre, researchers there will be conducting a trial to determine the prevalence of CCSVI in people with MS. Again, this study will be limited to local residents (I think current/former patients only) and will not include treatment, just testing.

Read more on CCSVI:

Comments
March 31, 2010 at 12:49 pm
(1) Colin Rose says:

The Albany “study” is an non-randomized, uncontrolled, unblinded, non peer-reviewed, observational exercise looking at “major adverse events” after the “liberation” procedure and, as such, has no scientific value. Just looking at major adverse events has no meaning unless they are counted in the context of the potential benefit or harm of a treatment on the symptoms and pathology of the disease itself in a properly controlled trial. Not performing these treatments as part of a scientifically valid trial is highly unethical and contravenes the Hippocratic Oath.

The study appears to be funded by “The Vascular Group” who will probably be charging patients for the privilege of having “liberation.” Any legitimate trial would be funded by a grant from government or a charitable agency which would be peer-reviewed for scientific validity and rated against other applications in the same category.

So, on the surface, this “study” appears to be a thinly-veiled attempt to attract paying customers, desperate to be rid of a debilitating disease, to this private facility on the pretext of doing science.

See my blog for more details on the pseudo-science behind “CCSVI.”

http://medicalmyths.wordpress.com/2010/02/10/zamboni-and-occult-art-of-ccsvi/

March 31, 2010 at 4:50 pm
(2) Tim Dreyer says:

Colin has left basically this same rant at every opportunity to post. I’m not exactly sure why he feels the need to hunt around the internet trying to say bad things about a procedure that is basically harmless, practiced very commonly for other conditions, and may indeed give MS patients relief from their symptoms – however small or large that relief might be.

If you had MS, and someone said, if you pay $5000 I can give you a 50%, 20%, or even 10% chance of reduced symptoms and a longer time without further disability, wouldn’t you jump at that chance? And what if…the theory is completely right and it stops the disease?

Colin, what are your motives? You are too angry to just be ‘doing the right thing’. Please stop your bombastic ravings. This is not a $50,000 life threatening t-cell transplant or $20,000 a year immune suppressing interferon medication, it is a balloon angioplasty. More tested than the other two, and harmless in comparison.

To Ms. Stachowiak, other CCSVI studies are underway in the US at the University of Buffalo, and at Georgetown University as well, that are out to prove two things: 1. Is CCSVI more prevalent in MS patients and 2. Will opening veins relieve MS symptoms.

March 25, 2011 at 12:18 pm
(3) sandy kendell says:

My daughter is a young mother of a four month old baby girl, and her symptoms of MS seem to be increasing. Here in Newfoundland, she cannot even get treatment reinstated, it was stopped when she was pregnant, until the “board” decides if she needs it. We cannot send her for CCCSVI which seems the best alternative, they do not do it in Canada, which is ridiculous, if I needed angioplasy, I could get it, but I do not have MS. It is very difficult to raise the amount of money needed to go abroad for the procedure, and to get a straight forward answer as to where the best place is for her to go to. Johns Hopkins seems the best, but when we phoned about it this morning, the person who answered the phone did not “know what we were talking about”. I have the most awful feeling that there is no desire to help people with this awful disease, this is Canada, and this is an unbelievable nightmare. There is a procedure that has been proven to help, What is the Holdup!!!
Sincerely: Sandy Kendell

March 31, 2010 at 9:41 pm
(4) J. Robinson says:

and Dr. Salvatore Sclafani who practices Vascular and Interventional Radiology and Diagnostic Radiology, Kings County NY – Insurance in the USA pays for the procedure if 50% or greater blockage is found.

See pdf link.. page 18

WHO WE ARE
The Center for Vascular Awareness, Inc is a 501(c)(3) not for profit organization dedicated to fostering mainstream consumer and clinical consciousness of vascular health standards, disease, prevention and treatment options.

March 31, 2010 at 10:11 pm
(5) Judy says:

First, thanks Julie for posting this information. I know that Boston University vascular department is starting studies up on CCSVI as well as Johns Hopkins and Georgetown. I will verify Hopkins after my appointment at Georgetown in the begining of May, but I have received word from their vascular department that the Hopkins vascular department will also be working on this.

Boston University Vascular on CCSVI

Colin? I have friends in other parts of the world, that are proven to have CCSVI, and a few have even had the Liberation procedure. I talk to those people and for them, the procedure has been noticeably successful. They are real happy as their MS symptoms have greatly improved.

You can see all that at my website and also check out our You Tube Group. Tgere are people there that have been liberated.

No one ever got ahead by being timid and not taking a chance.

March 31, 2010 at 10:31 pm
(6) Judy says:

Here is a more direct link for Boston University vascular: Boston Univ. to start CCSVI Study

And here is my MS site (Carl I should add your blog there) Really News – Your resource for all MS and CCSVI

March 31, 2010 at 10:38 pm
(7) Judy says:

click on my name for the Really News Website.

http://www.reallynews.com

Not sure why my link pointed back to ask.com

I have MS go figure. . . “Colin” I’ll add your blog to my site up with all the other sources.

April 2, 2010 at 6:08 am
(8) Lennart says:

Not even Dr Zamboni says heureka for CCSVI. What I find so are almost all people in the profession of the opinion that CCSVI is a subject for further research. And research is done in many places with serious people involved.
If then ms-patients – and there are many of them – are impatient and want to be examined and hopefully operated on it’s a natural thing. If one can’t understand this, I’m sorry.
Colin Rose is the only person who says that CCSVI is a hoax. Is he right? The future will tell. But why this arrogance?

June 15, 2010 at 9:27 pm
(9) George Kouri says:

The MS Controversy – an Actual Perspective

My wife and I just returned from Poland where she had the Liberation Treatment done by Dr. Simka and his Team on May 19th, 2010. Because all patients stay at the same hotel, it makes it very easy to meet, to talk and to bond with others – and to get first-hand accounts of how each person is feeling on a daily basis, both before and after the operation. There is no better evidence of the impact of this “Liberation” procedure than that. We met, saw, listened to and became witness to the physical and emotional reactions of 20 MS patients and the family members and friends who accompanied them. Real people – real reactions – and real human “research”.

EVERYONE reported “Some Relief” of their MS symptoms following the angioplasty operation. To repeat – ALL reported improvements.

Some were able to move fingers that they hadn’t moved before. Some stood up from their wheelchair for the first time in years. Cold hands and cold feet became warm and normal.
The colour in people’s faces was vibrant. Others reported “more energy” than ever before. Another couple was able to walk around the hotel, yes with her cane, but much farther than before she had the operation. Less fatigue was reported by several others.
All of these improvements were REAL – we witnessed the improvements, first hand. It was REAL.

Granted, no one threw away their cane or disposed of their wheelchair – but that is not what anyone in the group of 20 had sought, even hoped for. Please note that no one who takes drugs for MS expects to throw away their cane or dispose of their wheelchair – no one.

On the other hand, every MS sufferer wants “Some Relief” of their symptoms. The notion that we will find a cure for MS is rather preposterous, based on the historical evidence surrounding MS.

Drugs have been prescribed and taken by thousands with no reported “cure” or major improvement in symptoms.

As several people stated in our Liberation Treatment group in Poland – “I feel more relief now than at any time in the many years I’ve been taking drugs”.

All these facts beg several questions – questions that have not been addressed with honour and integrity by the MS Society – the MS Medical practitioners – and many others.

What is it that the MS Society and all the other so-called helpful institutes such as UBC – the Buffalo Center – St. Joseph’s Hospital in Hamilton – the False Creek Medical Center which featured the procedure done by Dr. Godley and reported in McLean’s – the Barrie Vascular Imaging Center which featured the operation done by Dr. Sandy McDonald – and others – want to prove?

Are they out to prove that the Liberation Treatment is a cure? No it is not – that has never been claimed. And by the way NONE OF THE DRUGS that MS patients have taken for decades have provided a cure, so why the double-standard?

Are they trying to prove that angioplasty is safe and easy to perform? That has been proven for decades.

What is it therefore, that they are trying to prove? What’s the purpose of the “research” they want to do? How serious are they when only $100,000 is allotted to the “research?

What is the real TRUTH that the MS Society is hiding? What is the Medical Community really afraid of? What is the influence that the Pharmaceutical companies have over the MS community and what role do they play in this “resistance movement”? Indeed, why the resistance to the Liberation Treatment from every MS corner in North America?

Is anyone out there honourable enough to help explain why there is such a deafening silence from the pharmaceutical companies who make drugs for MS treatment, and who are, presumably, the experts in MS?

Can someone out there prove that the drugs improve the symptoms of MS as much as the Liberation Treatment does?

We have belonged to a variety of MS patient groups – all we have seen and witnessed for the past 30 years is a deterioration of conditions and an inhuman suffering of all the side effects that the drugs cause. Why isn’t there “research” on the impact of these cruel and relentless side effects?

Here’s another question that begs for an answer. Why is it that the Westmount Square Medical Imaging Clinic, which is owned and operated by 26 Radiologists affiliated with McGill University, charging $1,250 for tests they claim are for CCSVI – but in fact are not accurate? YES, we have proof of this on disc!!

Why does the False Creek Clinic charge $1,600 for CCSVI testing, which has proven to be incorrect by Dr. Simka himself? Yes – there is proof of this as well.

35 years of cold hands and cold feet were relieved on May 20th, 2010 because of the procedure. Stamina was dramatically improved on May 20th because of the procedure. More walking steps were added because of the procedure. More movement in fingers and hands resulted because of the Liberation treatment.

WHICH DRUGS CAN MAKE SIMILAR CLAIMS????

The fact is that hundreds, perhaps thousands by now, have had the Liberation Treatment and have ALL SHOWN SOME IMPROVEMENTS. That is an unassailable fact.

Is the Liberation Treatment a cure? NO.

Does the Liberation Treatment result in an improvement in a variety of symptoms? YES – a resounding YES.

So what’s the resistance all about? Is it a legal issue – yet all the release forms and legalities of angioplasty have long been in place for decades? Is it a “power” issue between various elements of the medical community – at the expense of those who suffer with MS? Why is it that the very people who call for research use words like “hoax” and “criminal” and other such descriptions – yet none of these unsavoury words are founded in “research”?

The truly astonishing fact is that the entire Medical Community in North America has been placed in “SHUTDOWN” mode.

WHY?

George Kouri
416-346-4056

July 10, 2010 at 7:50 pm
(10) Laurel says:

I am in a hotel in Costa Rica with many women that have had this procedure 9 days ago. They are all from the US and Canada. They ALL report more mobility and warmer hands and feet. Some stood for the first time in years. Looks quite amazing to me. Its a shame that Americans need to leave their country for medical care like this.

September 3, 2010 at 7:33 am
(11) Eriks Teteris says:

C.R. is looking to find ‘MedicalMyths’ in everything he reads or writes (bit of a drama queen), but I don’t think he has done so with CCSVI at all. It is all happening currently, openly and being reported as such, not falsely. I shan’t waste my breath any further, as I have got a few sensible things to attend to.

October 16, 2010 at 4:53 am
(12) Verna Halloran says:

Colin Rose is a twit. He’s like the crazy ol’ guy ranting on the bus, just ignore him, he’ll go away although he’ll always be a ranting loon hoping someone will stop and pay attention to him. I’ve got way too much personal proof to bother wasting my time with the likes of him. Best way to deal with fools is to let them speak!!

March 31, 2011 at 7:51 pm
(13) Donald Ayres says:

Colin, I have been to your website and read your feelings on CCSVI. You talk about money wasted on CCSVI research that would be better spent on other research. How much money has been spent MS research and studies that ended up going nowhere? Isn’t that how science works? A hypothesis, a test to the hypothesis, and proof that either it works, or it doesn’t? CCSVI is barely two years old, and you’re ready to completely dismiss it out of hand. How long did it take after discovery of EAE before any medications came out of it? (none of which have proven effective for Secondary Progressive MS). Instead of being so adversarial, why not be supportive of the scientific process?

March 12, 2012 at 5:24 am
(14) Leo Voisey says:

Stem cells are “non-specialized” cells that have the potential to form into other types of specific cells, such as blood, muscles or nerves. They are unlike “differentiated” cells which have already become whatever organ or structure they are in the body. Stem cells are present throughout our body, but more abundant in a fetus.
Medical researchers and scientists believe that stem cell therapy will, in the near future, advance medicine dramatically and change the course of disease treatment. This is because stem cells have the ability to grow into any kind of cell and, if transplanted into the body, will relocate to the damaged tissue, replacing it. For example, neural cells in the spinal cord, brain, optic nerves, or other parts of the central nervous system that have been injured can be replaced by injected stem cells. Various stem cell therapies are already practiced, a popular one being bone marrow transplants that are used to treat leukemia. In theory and in fact, lifeless cells anywhere in the body, no matter what the cause of the disease or injury, can be replaced with vigorous new cells because of the remarkable plasticity of stem cells. Biomed companies predict that with all of the research activity in stem cell therapy currently being directed toward the technology, a wider range of disease types including cancer, diabetes, spinal cord injury, and even multiple sclerosis will be effectively treated in the future. Recently announced trials are now underway to study both safety and efficacy of autologous stem cell transplantation in MS patients because of promising early results from previous trials.http://www.neurosurgeonindia.org/

April 26, 2013 at 8:59 pm
(15) Gail Cerridwen says:

After having had this vascular procedure in Albany, I can firmly attest (as can others who witnessed my significant improvement) that one of the causes of this squirrely disease is certainly vascular. I won’t use the universal language many utilize regarding the debate, such as “only, “all,” “cure,” or even “cause” singular. It’s a complex disease.

However, one of my debilitating symptoms was an unrelenting fatigue unlike anything I’d experienced before. I could sleep 16 hours, get up to take my Adderall and Provigil, do a few minor errands, then go back to sleep two hours later. I felt dead.

Even though they said I didn’t have CCSVI, I did have some webbing and minor blockage so they went ahead with procedure. It’s now over two years later and ever since then that horrendous fatigue has been gone! The procedure didn’t “cure” my MS–I just had another attack–but I still feel like I got my life back.

May 11, 2013 at 6:09 pm
(16) Ward says:

Very good blog! Do you have any tips and hints for aspiring writers?
I’m planning to start my own site soon but I’m a little lost on
everything. Would you suggest starting with a free platform like WordPress or go for a paid option?

There are so many choices out there that I’m totally overwhelmed .. Any ideas? Many thanks!

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