Hubbard newsletter

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

Hubbard newsletter

Postby Cece » Thu Jan 31, 2013 9:56 am

Because neither MRV nor ultrasound has adequate sensitivity and specificity to be diagnostic, for our Registry FDA application, we are not requiring either of those tests. We are encouraging IVUS(intravenous ultrasound) which can be done at the same time as catheter venography which remains the gold standard. We hope to hear from the FDA within the month about restarting testing and treatment.

We've been encouraging IVUS here at TiMS for quite some time! I think IVUS is getting more mainstream than what it was. Great news.
We expect a response from the FDA regarding the Hubbard Foundation's request for an IDE for our Multi-Center Registry in early February 2013. The FDA had acknowledged our complete submission on January 6,2013 and has 30 days to respond. Based on their initial response in September 2012 we are cautiously optimistic.

Should know soon if their registry will be FDA approved and back in business.
C-Reactive Protein (CRP) and MS. Here's an abstract from a 2005 paper. http://www.ncbi.nlm.nih.gov/pubmed/16009907 We have become interested in the measure of serum high sensitivity C-reactive protein (HS-CRP) as the best measure available for monitoring low grade inflammation in the blood stream. We think one of the common denominators between CCSVI and MS is inflammation at the blood brain barrier (BBB). We believe that one can significantly decrease inflammation with diet. For instance, Arlene had a CRP of 9 and reduced it to .1 after being on a gluten free, modified Paleo diet. ( normal is considered 1-3 mg/L). This 2005 paper published in Neurology is one of the few papers linking CRP to MS. It showed that CRP was higher during relapses and was reduced by interferon treatment;everyone should have their CRP tested routinely and should consider dietary methods to reduce inflammation.


I posted more from the newsletter than I normally would but there was a lot of good information in there.
Here's the link to where you can sign up for the newsletter if interested: http://www.hubbardfoundation.org/ccsvi-education
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Re: Hubbard newsletter

Postby cheerleader » Thu Jan 31, 2013 10:27 am

Great news! Thanks for this, Cece.
Glad they're talking about Crp and our ability to reduce this with diet/lifestyle. That's what got Jeff's inflammation numbers down initially. His were sky high at diagnosis.
cheer
Husband dx RRMS 3/07
dx dual jugular vein stenosis (CCSVI) 4/09
http://ccsviinms.blogspot.com
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Re: Hubbard newsletter

Postby MarkW » Wed Feb 06, 2013 3:05 am

Cece wrote:
Hubbard Newsletter:
Because neither MRV nor ultrasound has adequate sensitivity and specificity to be diagnostic, for our Registry FDA application, we are not requiring either of those tests. We are encouraging IVUS(intravenous ultrasound) which can be done at the same time as catheter venography which remains the gold standard. We hope to hear from the FDA within the month about restarting testing and treatment.

I wish that the Hubbard Registry would state that Catheter Venography and IntraVenous UltraSound must be used in combination to detect all instances of stenoses. There is published evidence to say this and it would help pwMS when choosing which clinic to use.
Do the Hubbards read TiMS?
MarkW
Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 11 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html
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Re: Hubbard newsletter

Postby Cece » Wed Feb 06, 2013 8:06 am

Remember the Hubbards approved DIR, whose area of expertise was cementing spines. I am very glad that the Hubbards are encouraging IVUS. But I think they are taking all comers. Apologies to DIR, this is a bit harsh, and I have no idea how much experience DIR has gained since last year.
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Extract - April Hubbard newsletter

Postby MarkW » Wed May 01, 2013 2:52 am

What's News
•David met with the FDA in Silver Spring Maryland at 10 AM Fri April 26th accomanied by the research coordinator, Heidi Sauder PhD. The meeting lasted exactly an hour and was attended by 5 PhD's and MD's plus one on a video link. Overall, they were friendly and supportive. They explained that the reason they requested a "significant risk" investigational device exemption (IDE) was because balloons and stents are,themselves, are significant risk devices and not because of anything to do with CCSVI or MS. Based on the discussion David is submitting an amendment to his proposal and remains optimistic we will get the approval.

Not seen this posted before.
MarkW
Mark Walker - Oxfordshire, England. Registered Pharmacist (UK). 11 years of study around MS.
Mark's CCSVI Report 7-Mar-11:
http://www.telegraph.co.uk/health/8359854/MS-experts-in-Britain-have-to-open-their-minds.html
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