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CCSVI Trial Set for This Fall

(Posted By: Josi Creek)

 With health officials clamouring for more scientific research before green-lighting the new liberation treatment for multiple sclerosis (MS), local supporter and cardiovascular-thoracic surgeon Sandy McDonald is stepping up to provide it.

“I’m working with colleagues to design a double-blinded study for assessing CCSVI and its treatment,” he said, anticipating a more extensive test group than the preliminary trials first published by pioneering Italian vascular surgeon Paolo Zamboni.
“We have two neurologists, three vascular surgeons and interventional radiologists interested in being involved.”
In the process of gaining Institutional Review Board approval, McDonald said the trial is moving forward as quickly as possible, and could even start in the fall, but there are “a lot of hurdles to get past before we get there.”
Zamboni rocked the global MS community last November by linking blocked veins in the head, neck and shoulders to the symptoms of the disease – a condition he dubbed Chronic Cerebrospinal Venous Insufficiency (CCSVI). He took his hypothesis a step further when his team performed balloon angioplasties to free the blood flow. The reported results detailed alleviated MS symptoms.
McDonald travelled to Italy to study Zamboni’s unique vein-scanning techniques first-hand to avoid the false negatives often obtained through more traditional imaging.
He has since provided the non-subsidized tests at no cost to patients or the health-care system upon physician referral to his Alliance Boulevard clinic.
The actual procedure, however, is currently not available in Canada.?
Earlier this year, McDonald requisitioned six MS-related angioplasties for patients showing the tell-tale vein abnormality and associated iron debris, with follow-up visits revealing encouraging results across the board.
Some reported increased mobility and speech, and another claimed no further symptoms at all.
One young man’s parents had installed an elevator in their house to help their son’s mobility prior to the procedure. Now he is not only able to climb stairs without hesitation, but McDonald reports his patient has since moved into his own home where he lives independently.
After the positive results in his first few cases, McDonald and the interventional radiologists who performed the procedure decided to take a brief hiatus to first establish a method of capturing the data and tracking the results in order to share their findings.
Although the timeframe has stretched on longer than he initially anticipated, the surgeon now hopes to accept qualified patients into a full-scale research trial, complete with a treatment arm, come fall.
Nevertheless, McDonald said the approximately 1,000 successful liberation treatments done to date around the world should be enough to encourage the Canadian health-care system to allow the treatment as an option to patients – even if on a pay-per-service basis.


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