Research groups that want to conduct clinical trials of the "liberation" procedure for multiple sclerosis can now submit their plans for consideration, as Saskatchewan takes another step toward testing the unproven treatment.
The Saskatchewan Health Research Foundation (SHRF) on Friday issued a formal call for proposals, which looks to answer the question of whether the liberation procedure "is a safe and effective treatment for MS patients to relieve symptoms and improve quality of life."
The Saskatchewan government has pledged $5 million to finance clinical trials of the procedure, which involves angioplasty to open veins in the neck.
Researchers need to meet a number of requirements to be eligible for potential funding, including that at least a portion of the research team be from Saskatchewan, the SHRF said.
"For us, it's really an exciting stage. We've worked really hard with our advisory panel on this call for proposals and we hope that it inspires some really great researchers to put together proposals that will go forward and lead us to the clinical trials," said SHRF chief executive June Bold.
The SHRF notes that while the focus of the proposal is to achieve MS liberation treatment trials, there may need to be a "multi-stage approach."
"The reason we phrased it that way is because the science is changing pretty quickly. As the researchers who were funded to do diagnostic and imaging work move forward and some of their results start to be known, that can be factored in as the researchers who we'll be supporting with this funding develop their proposals," Bold said.
The funding provided by Saskatchewan needs to focus on Saskatchewan patients, but the SHRF said research teams "are welcome to include partners with funding in order to potentially expand the study to include patients from other jurisdictions."
With pressure mounting from MS patients who want the procedure, the Alberta government earlier this week promised to spend $1-million for an observation study and to fund clinical trials if it believes the treatment is safe.
The procedure is based on the hypothesis of Italian Dr. Paolo Zamboni that some MS cases are linked to blockages in veins carrying blood away from the brain.
While it's not performed in Canada, that hasn't stopped an untold number of MS patients from travelling out of the country to receive the liberation procedure.
The SHRF said letters of intent outlining intended proposals must be submitted by Jan. 31. Full proposals are due March 28.
A scientific peer review is to be completed by mid-April, with funding decision announcements to follow in late April.
"The successful research team will begin its study as soon as all ethical and operational approvals are in place -- ideally mid-to-late spring 2011," the SHRF said in a news release.
Bold said a precise date for when clinical trials will be underway can't be pinned down at this point.
"That will be up to the research team that's chosen," Bold said. "They'll put in place their plans and they'll have a process that they will set out and that's the time when we'll actually be able to say the starting point of the clinical trials. We're pretty clear in all our materials that it's a very high priority and we want that to be moving forward but we also want the researchers to be ensuring it's good scientific processes."
The SHRF also stated in its news release that MS patients in Saskatchewan "will play an important role in this clinical trial" but cautionned that there is no list where patients can register their interest.
"Patients are encouraged to watch for updates and announcements once the successful research team has been announced in 2011," the foundation said.
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