trial

[scorpion]

Let the trials begin!


http://www.cleveland.com/healthfit/inde ... wru_c.html

[Moom9335]

about time!

[Lyon]

.

[georgegoss]

Thanks for posting this Scorp.

If promising results lead to a larger, multicenter clinical trial that also yields good outcomes, Cohen said the treatment could be offered in a clinical setting within five to seven years.

And good news is now this is already happening with a larger international trial:

http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1405

For me, I would personally seriously consider this treatment following stopping of MS disease activity (following HSCT) because the science looks quite good.

BTW. . . Prof. Shimon Slavin is currently offering the same treatment that involves the necessary & critical component of culture expansion as I post on my blog:

http://themscure.blogspot.com/2011/06/g ... -have.html

International Center for Cell Therapy & Cancer Immunotherapy (CTCI) Tel Aviv, Israel
Professor Shimon Slavin

Here's the US-based MSC infusion phase I trial info. (In the title of this phase I Cleveland Clinic study they wrongly use the word "Transplantation." I really wish they had not used this nomenclature because this is not a classic transplantation procedure because it does not utilize chemotherapy and the wording is only likely to confuse some people. It is actually just a (re)infusion procedure. I'm not sure why the FDA let them incorrectly use the term "transplantation." Oh well.):

http://clinicaltrials.gov/ct2/show/NCT00813969

And here is a video report on the subject from Case Western:



For this therapy at CTCI, same as the Cleveland Clinic protocol, MSC's are collected from the patient's own bone marrow (probably surgically aspirated from the pelvic bone, but they may also do it by using a mobilization drug (G-CSF) and then perform PBSC collection from the peripheral bloodstream) and then the MSC's are replicated (culture expansion) ex-vivo over a period of 1-3 months to create a substantially large MSC population (in the neighborhood of 1-2 million stem cells per kilogram of body weight) and then re-infused back into the body. (Cleveland Clinic does it all via IV infusion directly into the bloodstream. Slavin does approximately 1/3 via IV infusion and 2/3 via intrathecal injections into the spinal column.)

The in-vitro research data with MSC's as treatment for MS looks quite promising. I'm not dismissing it, but because it does not include chemotherapy to ablate self-intolerant immune cells I would not personally do it as a first-attempt treatment because I think it extremely unlikely (or impossible) that it would stop the underlying MS disease process. Although. . . . . . I might seriously think about doing it following HSCT in the possibility that it may effect repair of already-damaged nerve structure & function. However, such an effect has yet to be proved or disproved in human clinical efficacy trials. Here is the small amount of preliminary phase I EDSS clinical outcome data as presented by Dr. Dimitri Karussis which is not negative, but is also not overwhelmingly positive nor consistent and is why today (without further data) I am somewhat ambivalent about the use of MSC's for MS. (click to enlarge):

<shortened url>

However, for everyone else considering such treatment the decision is yours, not mine. I'm just glad CTCI offers actual HSCT that includes chemotherapy that has already been repeatably-proven in population studies to be effective and enable substantial EDSS improvement following transplantation. But if you decide to chance-it and go for the MSC therapy alone without first eliminating the autoreactive immune cells of your body, don't be surprised if there is little, or no positive clinical outcome beyond a placebo effect.

The following video presentation by Dr. Dimitri Karussis who works, or worked together with Prof. Slavin describes the science behind the various treatment protocols they provide, including the MSC therapy (which I personally do not favor as first-attempt treatment but would consider it following HSCT once the antigen epitope has been rendered naive via chemo ablation):

http://www.informed-scientist.org/prese ... -sclerosis

CTCI homepage:

http://ctcicenter.com/index.php

Prof. Slavin Bio:

http://ctcicenter.com/index.php?option= ... icle&id=50

[ApVish]

But I don't like how the doc say

""We don't understand how it's working, even in the animal models. We know [the MSCs are] driving myelin repair, but we don't know all the molecules involved, all the cells involved. "

So there is some unknown and they are not sure if it will work in all MS people.

But nevertheless it is hopeful that there is something for MS people to try 5-7 yrs down the lane to stop the progression and some reversal of symptoms.

[CVfactor]

It will be interesting to see how this turns out over a long period of time. It seems to me they are putting the cart before the horse. To stop MS you first have to re-establish self tolerance, this much is clear. Repairing damage is an important secondary step. But I hope I am wrong which would be a good thing.

[georgegoss]

It will be interesting to see how this turns out over a long period of time. It seems to me they are putting the cart before the horse. To stop MS you first have to re-establish self tolerance, this much is clear. Repairing damage is an important secondary step. But I hope I am wrong which would be a good thing.

I have exactly the same opinion as you do regarding the necessity of first re-establishing immune self tolerance before meaningful repair can take place. (No sense in fixing the hole in the wall if someone immediately follows punching more holes in the wall. First-things-first, gotta remove that hole-punching person up front, then you can repair the wall without fear of additional damage.)

But overall I fully support this line of MSC work and sincerely hope it will be shown to be meaningfully beneficial.

[BadCopy]

The goal is to stop the hole from being punched in the boat, but how long is that going to take you? I am all for bailing out the water while repairing the hole in the boat at the same time. I think we have gotten pretty good at multi-tasking. At least that way we may stay afloat long enough to see the repair completed.

The more things that are tried, the more things are found. We should not be upset that funds or interest is being directed at CCSVI, STEM CELLS, NEW DRUGS, DIET, etc. One or more of those, or other, explorations will be, or help find, the answer we are seeking.
We should encourage each other. I hope that Stems are the answer. I hope diet, antibiotics are the answer. I hope there is an answer. And if it's the one you praise, that's great. If it's the one the drug makers want, that's great. We are all looking for the same thing. The Answer.

We can't be small pie people. There is plenty to go around.

[BadCopy]

A name to watch and see if it becomes a player in stem cell treatment with MS is Cytori Therapeutics

[packo]

But I don't like how the doc say

""We don't understand how it's working, even in the animal models. We know [the MSCs are] driving myelin repair, but we don't know all the molecules involved, all the cells involved. "

So there is some unknown and they are not sure if it will work in all MS people.

It is important that they are trying, when I was at Hadassah in late 2006 for HSCT, Prof. Slavin told me one interesting thing when I asked him about my prospects in the future:

“Guarantees? There are no guarantees. As Albert Einstein once said, we have to do 50 mistakes in order to do one very good and valuable thing.”

I replied: “OK, let us hope I am not going to be in those 50 mistakes !”

What I want to say, this guy is trying and doing his best to make something revolutionary, he is indeed a pioneer. If it wasn't for him, I am sure something like this would not start happening in other parts of the world. Back then in late 2006-early 2007 they harvested some of my cells in order to maybe do this in the future, but I never underwent this procedure. I am waiting to see some bigger “tangible” results, still, this worked for someone:

http://www.ctv.ca/CTVNews/Health/200811 ... nt_081116/

[Lyon]

.

[CVfactor]

Well, if you ignore all of the prior evidence regarding the science behind MS, I guess you can convince yourself to believe in CCSVI.

But the rest of the world needs a little more.

http://www.youtube.com/watch?v=2DJvn2Oi04g

(re-posted since the original was deleted).

[Lyon]

..

[georgegoss]

Well, if you ignore all of the prior evidence regarding the science behind MS, I guess you can convince yourself to believe in CCSVI.

But the rest of the world needs a little more.

http://www.youtube.com/watch?v=2DJvn2Oi04g

(re-posted since the original was deleted).

Thanks so much for posting that video, CV. I was especially glad to see this video because Dr. Klaus Schmierer aptly brings in the issue of The Scientific Method in evaluating CCSVI's causative relation to MS (there is none). As a physicist myself, The Scientific Method is the only proven way to conduct the study & proof of the natural world, which includes medicine. When applying such scientific principles to CCSVI, its clear that there is absolutely no demonstrated repeatible benefit. And if you can't repeat it, it's not a cure.

On the other hand. . . the randomized phase III HSCT clinical trials currently underway (in addition to the data developed in the phase II trials) clearly demonstrates scientifically and repeatably that rendering the body's immune system antigen-naive results in stopping of MS disease activity in the overwhemling number of patients (basically 100% of RRMS patients). To me (and most doctors / researchers) this clearly indicates that the underlying etiology of MS is firmly rooted in immune system dysfunction. Perhaps I should have instead studied psychology so I might better understand what it is about human nature that would make so many people trust & beleive in somethng that cannot be scientifically-verified while simultaneously ignoring the well-proven results of HSCT as a cure for MS?

Well, not everything is in my control. But my health (mainly) is. I'm glad my MS is 100% stopped, approaching two years now. I just hope others will also have an opportunity to experience the same/similar benefit. Regardless of what people believe, no matter how absurd, I sincerely hope they will beat their MS.

[CVfactor]

George,

Yes, I think CCSVI really doesn't fit into what is known about MS. But in my view it is no skin off of my nose if someone wants to pursue this as an approach to their disease.

The thing that really is disingenuous from a lot of people who are supporters of CCSVI is that this is a cure and that the autoimmune theory has not led to any insight into what causes MS or how it can be stopped.

I guess you could have this view if you are an ignorant person. But the people on the cutting edge of MS research (not clinical medical doctors) have found that MS as well as a lot of other autoimmune diseases are the results of a loss of self tolerance, and in particular a defect in the newly discovered regulatory T-cell. I have a lot of respect for these scientists and I think they would be most disappointed if they read some of the posts coming from the CCSVI fanatics.

But this type of toxic view point may prompt some people to jump on the CCSVI bandwagon and this is the only problem I have with the CCSVI movement (aside from the doctors who are performing this procedure). I think the CCSVI proponents should take some responsibility for those people who underwent this procedure and sustained permanent damage (at least if they had a conscience).

But in the end, truth and science will not be on their side, and they will fade off into the background as people of this ilk have always demonstrated in the past.