The Canadian Institutes of Health Research is ready to accept proposals for clinical trials on the proposed condition behind multiple sclerosis known as CCSVI, Health Minister Leona Aglukkaq announced Friday.
Health Canada announced in June it had agreed with a recommendation from the CIHR that Ottawa should support a clinical trial. Criteria for the trial have now been established and the government's health research funding agency is making the call for proposals.
The government has been under heavy pressure to fund a procedure known as the Zamboni treatment, or liberation therapy, which is not sanctioned in Canada. It set up an expert advisory panel last year to weigh the evidence for and against both the theory behind CCSVI and the procedure.
The procedure is named after the Italian doctor who spearheaded it, Dr. Paolo Zamboni, who coined the term chronic cerebrospinal venous insufficiency to describe the phenomenon he believes contributes to MS. The idea is that blocked or narrowed veins in the head and neck trigger the debilitating symptoms of MS, and he developed a procedure in which tiny balloons or stents are inserted in the veins – a form of angioplasty.
Some Canadians have travelled abroad to have the procedure done, and report relief from their symptoms but some have developed complications upon their return and have had trouble getting followup care. Inserting stents into veins is considered a risky procedure that can cause blood clots.
Seven studies are underway in North America, sponsored by the MS Society of Canada and its U.S. counterpart, that are looking at whether vein abnormalities and MS are linked, as Zamboni proposed. The studies started in July 2010 and are expected to take two years.
The federal government had resisted calls for a clinical trial initially, saying the seven studies were underway and more information was needed about CCSVI before a clinical trial could go ahead. In June, Aglukkaq said there was enough preliminary evidence from those studies to warrant proceeding with a clinical trial, news that was welcomed by patients who want access to the procedure.
"This next step will help identify a proposed clinical trial which can then undergo ethical review. At every step of this process, patient safety must be first and foremost," Aglukkaq said in a statement.
The request for research proposals will be posted on CIHR's website on Nov. 30. Applications will be reviewed by an international peer-review team in early 2012 and the winning proposal will be announced by March.
How many patients will be included in the trial, and how much it will cost the federal government, will depend on what is proposed by the winning bid.
The federal government is budgeting $3 to $5 million for the project.
Aglukkaq updated her provincial and territorial counterparts on the latest development in the lengthy clinical trial process when she met with them in Halifax on Friday.
Saskatchewan has already started work on getting residents there to participate in clinical trials. About 80 MS patients from that province have already been accepted into a clinical trial underway in Albany, N.Y., the province's health minister said Friday.
"What we will be doing now is joining with the federal government, certainly on anything that their initiative will take us to," said Don McMorris.