Highlights from the June 28th, 2011 CIHR Scientific Expert Working Group Meeting

A meeting of the Scientific Expert Working Group was held in Toronto, Canada on June 28, 2011 (meeting agenda).

The Scientific Working Group reviewed data relating to Chronic Cerebrospinal Venous Insufficiency (CCSVI) presented at international meetings and then were presented the draft results of a systematic review of peer-reviewed publications regarding CCSVI and MS. The systematic review will be submitted by the principal investigator and his collaborators for publication to a peer-reviewed journal. Once published, the link to the article will be posted on the CIHR website.

An update was provided by study investigators regarding progress of the 7 North American studies funded by the MS Society of Canada and National MS Society (US).

Finally, attendees discussed ethical considerations of potential future directions for CCSVI research in Canada.

Summary of meeting:

  • All 7 funded studies have made good progress and many are well on their way to having their target number of subjects recruited. A total of 1267 individuals with MS and controls will be recruited over the course of the studies.

  • The Scientific Expert Working Group will continue to monitor and analyze the data from the 7 funded studies and other studies related to CCSVI and MS around the world.

  • The Scientific Expert Working Group recommended that CIHR support a Phase I/II interventional trial.

  • This Phase I/II interventional trial will be designed to: (i) ensure standardized and accurate identification of MS patients meeting defined criteria for CCSVI; (ii) evaluate key measures that are sensitive to patient-reported outcomes of venoplasty; (iii) conduct the necessary safety evaluations of venoplasty for CCSVI including health risks such as blood clots; and (iv) evaluate whether the results of venoplasty are sustained over several months post-procedure.

  • To enhance the ability to compare data between the 7 studies, a consensus workshop for the ultrasound imaging will be held to share information and determine the best way of standardizing imaging of veins in the neck and brain. The standardized ultrasound methods optimized in this workshop will help ensure standardization of the seven ongoing studies and will contribute to the design of a Phase I/II interventional trial.

  • The next meeting of the CIHR Scientific Expert Working Group will be held in the first quarter of 2012 with a telephone conference call in the fall of 2011.

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