APPROVED!!! FDA Registry for MS CCSVI Treatment and Data Collection

News Update

FDA Registry Status
FDA approves venoplasty research for MS!!!!


Today the FDA finally and formally approved our Registry to treat and follow MS patients with abnormalities of their internal jugular and azygos veins. In May 2012, FDA stopped all CCSVI (chronic cerebrospinal venous insufficiency) research without their approval as an “investigational device exemption” (IDE). Hubbard Foundation immediately applied for the exemption and today a year and a half later, and after virtually monthly objections and revisions, we finally received approval.
Background: CCSVI is the hypothesis that myelin-making brain cells are susceptible to oxidative stress caused by delayed drainage or reflux in neck and chest veins. The neurology community have aggressively resisted this hypothesis and its further study.

The next step is submission of the FDA documentation to the IRBs for each P.I. interventional radiologist. This will take several weeks. We will post the participating sites on the Hubbard Foundation website www.hubbardfoundation.org
The FDA has allowed only 662 MS patients, only 10 interventional radiologists,and has added restrictions and safeguards. Unfortunately this registry is not a funded study, MSers will have to pay for the treatment. We will post the informed consent and other forms on our website soon.
We want to thank all of you for your support and patience. These have been challenging times.


The Hubbard Foundation |
www.hubbardfoundation.org
If you are interested in participating, please go to the CCSVI Registry Overview page, complete the form and submit.Check back here for updates on the approval progress and the criteria for eligibility.