Canada's Health Minister Leona Aglukkaq announced Wednesday that the federal government will fund a clinical trial for "liberation treatment," an experimental vein therapy for multiple sclerosis developed by an Italian doctor.
The MS Society of Canada, a co-funding partner of the project, said it's "thrilled" by the announcement that may bring "definitive answers" about the controversial treatment developed by Dr. Paolo Zamboni.
The clinical trial for Chronic Cerebrospinal Venous Insufficiency (CCSVI) in Canadians with multiple sclerosis seeks to determine the safety of venous angioplasty, also known as "liberation treatment" which requires the opening of blocked veins, the Canadian Institutes for Health Research said in a release about the announcement.
Liberation treatment rejects long-held medical opinion that MS is an autoimmune disease. At least two Canadians have reportedly died overseas from complications of the procedure, which is currently unavailable in Canada.
Asked about the controversy surrounding the procedure, MS Society of Canada CEO Yves Savoie said he supports the call of those concerned about the treatment for more rigorous research.
"We're thrilled at this very important step and because of this question of the risk, that's why there are appropriate safeguards for participants going to be involved in that, including an ethics approval," he said.
The trial is subject to an ethics approval in Canada in "a way that balances our hunger for innovation and research with respect for dignity of human life," Savoie said.
The government is withholding the names of the researchers and institutions involved in the project "to protect the independence" of the ethics review, according to CIHR which launched a call for research applications to select the team of researchers.
Savoie said withholding the names is standard CIHR practice and will ensure that the ethics approval process "can happen without intense public pressure."
The trial will only begin after ethics approval is granted, he added.
Meanwhile, a 2011 study by a team of University of Calgary doctors found complications for five MS patients after undertaking liberation treatment abroad.
"As the debate about CCSVI and its relationship to MS continues, the complications and risks associated with venous stenting and angioplasty in jugular and azygous veins are becoming clearer. As increasing numbers of MS patients are seeking such procedures, these five cases represent the beginning of a wave of complications for which standardized care guidelines do not exist," the Calgary neurologists wrote in The Canadian Journal of Neurological Science.
CIHR said it will continue to review and analyze any new research evidence on CCSVI.
"CIHR and the MS Society will continue to collaborate with provincial and territorial partners to ensure implementation of the clinical trial if the team of researchers meets the research ethics boards criteria," said CIHR president, Dr. Alain Beaudet in a statement.
Canada has among the highest MS rates in the world. There is no known cure, but symptoms may be managed.
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