Canadian Working Group Recommends Against Funding for Controversial MS Trial
By Nancy Walton
On August 2nd, we blogged about the controversial treatment for MS, called the “liberation procedure”, created by Italian neurosurgeon Paolo Zamboni, who has theorized that MS is caused by a narrowing of the veins that drain blood from the brain, a condition known as chronic cerebrospinal venous insufficiency (CCSVI). His procedure, which is basically a venous angioplasty, opens up the veins allowing for better drainage and, according to his studies, helping to cure MS. The link that he has claimed exists between CCSVI and MS is highly controversial.
Across Canada, provincial governments are trying to decide if they will help fund clinical trials to further test the procedure for patients with MS. Saskatchewan (the province with the highest prevalence of MS) has confirmed that they will support fund clinical trials of the procedure but so far, there are no commitments from other provinces one way or the other.
But now, a working group from the Canadian Institutes of Health Research and The MS Society of Canada have unanimously recommended against supporting clinical trials of Zamboni’s procedure in Canada, according to a CBC news story this morning. They have recommended that a Canadian/US working group be formed to analyse outcomes from CCSVI studies elsewhere in the world and over time, make further recommendations about pursuing research on the link between CCSVI and MS before forming conclusions about the validity of the treatment.
Here’s a link to the story: Experts urge rejection of MS therapy trial
In a Globe and Mail report on this story, the president of CIHR is quoted as saying,“There was unanimous agreement from the scientific experts that it is premature to support pan-Canadian clinical trials on the proposed ‘liberation procedure’. There is an overwhelming lack of scientific evidence on the safety and efficacy of the procedure, or even that there is a link between blocked veins and MS.”
There have been no independent replications of Zamboni’s work (which has been criticized from a methodological standpoint). Claims about the success of the procedure are anecdotal and these claims, as the CBC story notes, are motivating patients to spend thousands of dollars seeking the procedure elsewhere. What is unknown is whether the procedure is being offered elsewhere as part of a trial or as a therapeutic/curative intervention for those who might be willing to pay for it and travel to get it.
This will be an interesting story to follow. Tomorrow the Health Minister Leona Aglukka will hold a press conference to comment on the recommendations of the working group.
Research Ethics Blog 
[…] Of course, clinical trials may not happen soon. We blogged before, for instance, about Canadian recommendations against funding clinical trials: Canadian Working Group Recommends Against Funding for Controversial MS Trial. […]
Zamboni: “Wait for trials.” « Research Ethics Blog said this on October 17, 2010 at 12:44 pm |
After 6 months of offering stem cell therapy in combination with the venous angioplasty liberation procedure, patients of CCSVI Clinic have reported excellent health outcomes. Ms. Kasma Gianopoulos of Athens Greece, who was diagnosed with the Relapsing/Remitting form of MS in 1997 called the combination of treatments a “cure”. “I feel I am completely cured” says Ms. Gianopoulos, “my symptoms have disappeared and I have a recovery of many functions, notably my balance and my muscle strength is all coming (back). Even after six months, I feel like there are good changes happening almost every day. Before, my biggest fear was that the changes wouldn’t (hold). I don’t even worry about having a relapse anymore. I’m looking forward to a normal life with my family. I think I would call that a miracle.”
Other recent MS patients who have had Autologous Stem Cell Transplantation (ASCT), or stem cell therapy have posted videos and comments on YouTube. http://www.youtube.com/watch?v=jFQr2eqm3Cg.
Dr. Avneesh Gupte, the Neurosurgeon at Noble Hospital performing the procedure has been encouraged by results in Cerebral Palsy patients as well. “We are fortunate to be able to offer the treatment because not every hospital is able to perform these types of transplants. You must have the specialized medical equipment and specially trained doctors and nurses”. With regard to MS patients, “We are cautious, but nevertheless excited by what patients are telling us. Suffice to say that the few patients who have had the therapy through us are noticing recovery of neuro deficits beyond what the venous angioplasty only should account for”.
Dr. Unmesh of Noble continues: “These are early days and certainly all evidence that the combination of liberation and stem cell therapies working together at this point is anecdotal. However I am not aware of other medical facilities in the world that offer the synthesis of both to MS patients on an approved basis and it is indeed a rare opportunity for MS patients to take advantage of a treatment that is quite possibly unique in the world”.
Autologous stem cell transplantation is a procedure by which blood-forming stem cells are removed, and later injected back into the patient. All stem cells are taken from the patient themselves and cultured for later injection. In the case of a bone marrow transplant, the HSC are typically removed from the Pelvis through a large needle that can reach into the bone. The technique is referred to as a bone marrow harvest and is performed under a general anesthesia. The incidence of patients experiencing rejection is rare due to the donor and recipient being the same individual.This remains the only approved method of the SCT therapy.