Please post any CCSVI Clinical Trial Information

A forum to discuss Chronic Cerebrospinal Venous Insufficiency and its relationship to Multiple Sclerosis.

Please post any CCSVI Clinical Trial Information

Postby jr5646 » Tue Dec 08, 2009 9:04 am

I don't have anything substantial to report, but wanted to leave a few resources for those of you who may be interested. It can't hurt to be informed when and if the opportunity presents itself..

Please add to this list if you can !!!!

1) ClinicalTrials.gov is a registry of federally and privately supported clinical trials conducted in the United States and around the world.

http://www.clinicaltrials.gov

2) Stanford's Clinical Trial Directory

http://med.stanford.edu/clinicaltrials/results.do?type=dept&id=o029

3) Lawerence Steinman - MS Researcher at Stanford
(would be great if he gets involved - volumes of research)

http://steinmanlab.stanford.edu/

4) Stanford's Human Subjects Research and IRB Home Page

http://humansubjects.stanford.edu/

5) FDA Clinical Trials and Drug Development

http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm117893.htm

6) US Dept. of Health

http://www.hhs.gov/ohrp/faq.html
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Postby Ruthless67 » Tue Dec 08, 2009 10:30 am

With all due respect, jr5646

After reading up on Lawrence Steinman M.D., I wonder if he isn’t a fly in the ointment? I sight the fact that he is the Founder of Bayhill Therapeutics and honored with the 2004 National MS Society/American Academy of Neurology's 2004 John Dystel Prize for Multiple Sclerosis Research, for his major contributions to our understanding of MS-like disease models, and for translating these findings to the clinical development of novel therapeutic strategies for MS. And that $816,750 award is good only until 3/31/10.

Here’s more:


PALO ALTO, Calif.--(BUSINESS WIRE)--April 27, 2004
Professor Lawrence Steinman, MD, of Stanford Medical Center and Founder of Bayhill Therapeutics, has been chosen by a committee of his peers to receive the 2004 John Dystel Prize for Multiple Sclerosis (MS) Research. Dr. Steinman is being honored for his major contributions to scientific understanding of MS-like disease models, and for translating these findings to the development of novel therapeutic strategies for people with MS.
"MS starts in a few trees and then starts burning the whole forest," said Lawrence Steinman, MD, a ...

SAN MATEO, Calif. -- Bayhill Therapeutics Inc., a clinical-stage biopharmaceutical company leveraging its proprietary BHT-DNA[TM] platform to develop novel and targeted autoimmune disease treatments, today announced that Lawrence Steinman M.D., Professor of Neurology, Pediatrics and Genetics at Stanford University and Founder, Director and Scientific Advisory Board Chairman of Bayhill Therapeutics, has been awarded an endowed chair at Stanford as the George A. Zimmerman Professor. Dr. Steinman is the inaugural holder of the chair, funded to support multiple sclerosis (MS) ...

Nuon Therapeutics' founding scientists, Marc Feldmann, MD, PhD and Larry Steinman, MD, have conducted wide-ranging preclinical testing of tranilast.
...
Professor Steinman is professor, Departments of Neurology and Neurological Sciences, Stanford University, and a specialist in multiple sclerosis (MS).His research identified the biological pathways that led to the development the MS therapeutic, Tysabri®.Professor Steinman's work with tranilast showing improvement in an animal model of MS was published in the journal Science.
...
The company's scientific founders are Prof. Larry Steinman at Stanford University, Palo Alto, Prof. Marc Feldmann, Imperial College, London, and Dr. Michael Selley, formerly from the Australian National University.

Collaborative MS Research Center Award
$816,750; 4/1/05-3/31/10
Principal Investigator
Lawrence Steinman, MD
Stanford University, Palo Alto, Calif.

http://www.nationalmssociety.org/resear ... index.aspx

So it will interesting to see if he comes on board with CCSVI, especially if it receives funding, or if he goes looking for more pharma monies.

Lora
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Postby jay123 » Tue Dec 08, 2009 10:53 am

I didn't have those details but that's why I posted before that getting the neuro department involved is nothing but bad for us. Between their prejudices and the fact that they will now probably argue for MONTHS before an acceptable trial is agreed upon.
The only way this even got started is because an intelligent, independent, non-neuro saw the data and said it makes sense but that was because he hasn't spent his life pursuing other theories.
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Postby jr5646 » Tue Dec 08, 2009 1:54 pm

Hi Lora... I initially felt getting neuros involved was going to be a bad idea, but now I'm completely convinced they need to work together.

I think you are wrong about Steinman. Please take a look at his CURRICULUM VITAE:
http://med.stanford.edu/profiles/Lawrence_Steinman/

1) Practically most, if not all all ms research is looking at drug therapy..

2) Let's assume CCSVI pans out for a second... The mechanism that allows an excess buildup of iron in the cns is repaired (no more blockage / iron buildup). Is the BBB damaged too? How do we remove the excess iron and the immune response from the cns? If the iron is removed, will the immune cells doing cns dammage simply go away or do they continue doing damage? Can any residual damage be repaired? All the more reason to have a neurological component involved.

3) Have you reviewed some of this guys work? Just scan the titles, of almost 500. Extremely impressive...

4) Isn't Dake doing research for a stent manufacturer?

5) Maybe he started his own company because he was sick of big dictating pharma.

6) Even though Steinman's developments in monoclonial antibodies led to the development of TYSABRI, I believe he adamently warned folks about the dangers and advised not to use it.

7) Bayhill is working on a vaccine to re-train the immune system in conjunction with a vascular drug:

http://www.medicalnewstoday.com/articles/80011.php

Plus, I think he's in the same building as Dake ! and if this guy is as good as he looks at getting funding, they'll need it... the research isn't going to happen for free, ya know !

Who knows, the clinical trial (when and if does depvelop) may simply focus in on the newly DX and hang us all out to dry... I can only hope and pray not.


-John
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Postby Ruthless67 » Tue Dec 08, 2009 6:43 pm

jr5646,

I truly hope your right and I'm wrong and that Dr. Steinman, is one of the "Good" guys for CCSVI, because with his funding ending on 3/31/10 he'll be looking for more funding and we could definately use him on the side of CCSVI!!!

Lora
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Postby jay123 » Wed Dec 09, 2009 8:02 am

If you read the email that was posted you would understand that the MS department will do anything they can to throw roadblocks in front of Dr. Dake.
It's going to take a long time.
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Buffalo study

Postby SandyK » Wed Dec 09, 2009 11:57 am

Good morning. I received an email with an attached questionnaire about CCSVI testing, "The study procedures include doppler/ultrasound testing, blood collection, a clinical examination."

If you would like me to post the email I will. It does stress that this is scans only and and I arrive at my own expense. I live in WA. Ouch!

I filled out the questionnaire but I don't have answers to some of the questions because I don't have a doctor and I have no idea what an EDS score is! 16 years with MS and I haven't a clue.
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Postby ozarkcanoer » Wed Dec 09, 2009 12:03 pm

SandyK, Do you know who the organization is that sent you this email ? It would be nice for us to see the body of the email if you feel comfortable doing that.

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Re: Buffalo study

Postby jr5646 » Wed Dec 09, 2009 12:28 pm

SandyK wrote:Good morning. I received an email with an attached questionnaire about CCSVI testing, "The study procedures include doppler/ultrasound testing, blood collection, a clinical examination."

If you would like me to post the email I will. It does stress that this is scans only and and I arrive at my own expense. I live in WA. Ouch!

I filled out the questionnaire but I don't have answers to some of the questions because I don't have a doctor and I have no idea what an EDS score is! 16 years with MS and I haven't a clue.


Thanks Sandy... geez, I'd love to hear more, but after what happened yesterday posting e-mail
http://www.thisisms.com/ftopict-9200.html
I would prob. check with the source first to see if it would be ok, which I'm sure they wouldn't mind...

I think you're talking about this:

http://www.bnac.net/?page_id=517

"Currently, enrollment will be closed until late January 2010 in order to evaluate initial study results on first 500 enrolled subjects. If you would like to be considered for this study or any future studies, please follow the instructions below."

Plus, I believe I read where they don't give you your scans??

Check here for EDSS info. > You can do a self eval.
http://www.thisisms.com/ftopict-8346.html (Red text links)

Expanded Disability Status Scale

THX

-John
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Buffalo study

Postby SandyK » Wed Dec 09, 2009 1:49 pm

Buffalo Neuroimaging Analysis Center sent me the email.
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Postby ozarkcanoer » Wed Dec 09, 2009 1:52 pm

SandyK... I would jump at the chance to participate in the BNAC study. Of course if you live too far away and it is inconvenient to travel to Buffalo, I can certainly understand that. Let us know what happens !!!
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Postby tzootsi » Wed Dec 09, 2009 2:03 pm

I believe the Buffalo testing does not give you any information on what they found, it is a blind study. I was told the only info they would share on individual results would be an MRI. My wife was very interested in participating in the study, but since they won't let us know if she has any blockages, and since we are over 8 hours driving time away, she probably won't participate. If we lived closer, there is no question we would do it. We will however, contribute to their fund raising campaign. I wish there was somewhere within a few hours of us (New Hampshire) that we could go for testing and or studies.
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Postby magoo » Wed Dec 09, 2009 4:55 pm

I may be wrong but I was told a top MS Specialist (Steinman) at Stanford is making things REALLY hard for Dr. Dake. He completely opposes the work being done on CCSVI. He's making a big ruckus and is an opponent, not a supporter. One of his patients had a serious complication with the stent surgery.......
Rhonda~
Treated by Dake 10/19/09, McGuckin 4/25/11 and 3/9/12- blockages in both IJVs, azy, L-iliac, L-renal veins. CCSVI changed my life and disease.
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Postby jr5646 » Wed Dec 09, 2009 5:21 pm

Ruthless67 wrote:jr5646,

I truly hope your right and I'm wrong and that Dr. Steinman, is one of the "Good" guys for CCSVI, because with his funding ending on 3/31/10 he'll be looking for more funding and we could definately use him on the side of CCSVI!!!

Lora


I never really stated Steinman was a good or bad guy for ccsvi.. I just thought that with Dake's vascular expertise added to Steinmans MS knowledge and thier close proximity to one another that it would be great if they could collaborate.....

Anyway, I guess it really dosen't matter though, unless until a neuro is brought into the mix.. We can debate it then - :) As some have already stated, a clinical trial may simply be a vascular one (with no mention of MS)... IF blockage in a vein occurs, is it more effective and safer to angio or stent, or a combo?

If it is more than that, they'll probably need the neuros involved...

What has my curiousity peaked now, is who is going to pay for such a trial???? I couldn't even begin to imagine how expensive it would be? Would a stent manufacturer sponser? Stanford? Who?

Has Dake been gathering data that could potentially be presented to the stent companies? With an estimated 400,000 of us in the US alone times 1 to 4 stents each... If this is the case, you would think they would sit up and listen..

Maybe Obama could fork over some of that stimulus money ;-)

I do think however regardless of a trial, we're still going to need continued treatment after any surgery.. both vascular and neurological.. The newly DX may not...but who can really say for sure?


Steinman's DNA Vaccine which re-trains the immune system to NOT attack myelin, looks very interesting and may compliment ccsvi surgery.. Kinda similar to HiCy adding copaxone to re-train the newly developing immune system to not attack the cns.

http://www.bayhilltherapeutics.com/

Lets say the MS trigger can now be fixed (eliminate drainage / blockage issues / reflux) Now the wounds need to heal.. OK - how do we get the damn iron "bullets" out?? Can we leave them in...???

My 2 cents...
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Postby jr5646 » Wed Dec 09, 2009 5:37 pm

magoo wrote:I may be wrong but I was told a top MS Specialist (Steinman) at Stanford is making things REALLY hard for Dr. Dake. He completely opposes the work being done on CCSVI. He's making a big ruckus and is an opponent, not a supporter. One of his patients had a serious complication with the stent surgery.......



Rhonda,

You were just out there too... thats a shame....

Most would think the neuros would get territorial (protect thier intrests), but to have a patient with complications is a double wammy...

Any insight on a trial???

Thanks,
John
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