SkepticblogSkepticblog logo banner

top navigation:

CCSVI – The Importance of Replication

by Steven Novella, Aug 02 2010

Scientists and skeptics are familiar with this pattern – a preliminary study suggests a wildly new understanding of a scientific or medical question. The scientific community is cautiously skeptical but interested. The press proclaims a stunning breakthrough, and the public is briefly fascinated. If the new discovery concerns a medical treatment, the community of those affected become fixated on the potential new “cure”, and many start demanding treatment based solely on the preliminary evidence. But then the wheels of research begin to grind and, more often than not (because that is the nature of discovery) the new idea turns out to be wrong – it fails the critical step of replication.

Then one of two things will happen: either the new idea or treatment will fade, becoming little more than a footnote in the history of science, or a subculture will persist in believing in the treatment and will dismiss contrary evidence and mainstream rejection as a conspiracy. Which course the new idea will take seems to depend largely on the original scientist – if they accept the new evidence and abandon their claims, it will likely fade. If they refuse to give up in the face of new evidence, then a new pseudoscience will likely be born.

We have seen this pattern play out with Laetrile, psychomotor patterning, cold fusion, and many other ideas.

Now we are in the midst of this pattern playing itself out yet again – with the Zamboni treatment for multiple sclerosis (MS). Dr. Zamboni is an Italian neurosurgeon whose wife as MS. He sought out to find a cure, and eventually discovered that patients with MS have a blockage in the venous draining of their brains, a condition he termed “chronic cerebrospinal venous insufficiency” (CCSVI). He further claims that MS can be treated, even cured, by opening up the veins that drain the brain with either angioplasty or stenting. Many MS patients have been interested in this potential new treatment, and many have even undergone treatment.

The neurological community is, to say the least, skeptical – but interested. There are many red flags of crankery in CCSVI, however. First, it may make for good story telling, but it is a bit curious that a neurosurgeon set out to discover a treatment for MS and found a neurosurgical one – even though there was no prior suggestion that this would be the case. Further, we have decades of research that tell us that MS is primarily an autoimmune disease – the patient’s immune system is attacking their own central nervous system. It is true that inflammatory plaques tend to occur around veins, but that is explained by the fact that blood vessels allow immune cells access to the central nervous system.

And finally Zamboni found in his own research that his criteria for CCSVI has 100% sensitivity and 100% specificity for MS – which triggers the “too good to be true” red flag. It is rare (perhaps nonexistent) to find a test in medicine that is correct 100% of the time, with no false positives or false negatives. These kinds of results strongly suggest experimenter bias.

Zamboni presented his research at the latest meeting of the American Academy of Neurology. I was not present, but I have spoken to some colleagues who were – the buzz is that Zamboni’s presentation was not impressive, and he came off as a bit of a crank. This by itself does not mean much – it’s more about personality than data – but it’s not surprising given the pattern I have outlined above.

The only reasonable response to such claims is cautious interest, and that is exactly what the medical community has done. In general most neurologists acknowledge that Zamboni’s claims need to be replicated and researched. Perhaps he is onto something, even if he is overstating the claims. Perhaps the perivenous inflammation of MS leads to CCSVI which exacerbates MS. Maybe Zamboni has found a piece to the puzzle, even if he has not solved the whole thing in one fell swoop.

Well now we have two independent replications of Zamboni’s research published in the latest issue of the Annals of Neurology – and both are completely negative. The first is a German study by Florian Doepp et al, using ultrasound to test the CCSVI criteria in 56 MS patients and 20 controls. They found almost completely negative results (one MS patient met one criterion, but not the others) – no signs of venous blockage in the MS patients.

The second study is a Swedish study by SundstrÃm et al (“Venous and cerebrospinal fluid flow in multiple sclerosis – a case-control study.” Peter SundstrÃm, Anders WÃ¥hlin, Khalid Ambarki, Richard Birgander, Anders Eklund and Jan Malm. Annals of Neurology) – not yet available online. This study used MRI scanning to assess blood flow in the internal jugular vein in 21 MS patients and 20 controls, and also found no difference.

Conclusion

These two studies are not going to be the final word on CCSVI and MS, but they are very important in signaling a note of caution to patients and clinicians about this new hypothesis. The treatment for CCSVI is invasive and has serious risks, and should not be undertaken lightly. I agree with the current consensus that evidence for CCSVI is too preliminary to warrant treatment, especially given the risks.

I do wish that the media and public would learn the more general lesson here – new dramatic ideas in science, especially those that seem to go against established knowledge, are likely to turn out to be wrong when the dust settles. It is partly the job of the skeptical community to provide cultural memory of such events – so the next time a lone scientist or doctor claims to have made a revolutionary breakthrough that seems a bit dubious, it is the skeptics who will be there to say – remember Zamboni.

46 Responses to “CCSVI – The Importance of Replication”

  1. Max says:

    At least the Zamboni treatment doesn’t involve a big ice resurfacer.

  2. tmac57 says:

    How frustrating and disappointing this must be for MS patients and their families.

  3. Derek Dadey says:

    Interesting.I live in Sasktchewan(province),Canada and recently our provincial govt stated they’d be funding clinical trials for I believe this particular therapy. The news report mentioned that other provinces weren’t interested in aiding in funding due to the contoversial nature of the research. They expect to start recieving research proposals in the next few months.

    • MadScientist says:

      For a second there I thought you wrote “Sasquatch Province” – bleh – I’ve been seeing too many bigfoot posts lately.

  4. Al says:

    Hi. I wanted to post the buffalo study. Also, I think Zamboni is a vascular surgeon who found a vascular cause, not neuro.

    http://www.bnac.net/wp-content/uploads/2010/02/first_blinded_study_of_ccsvi.pdf

    “When the 10.2 percent borderline subjects were included in
    the “normal” category (no venous insufficiency), the CCSVI
    prevalence was 56.4 percent in MS subjects and 22.4 percent in
    healthy controls.”

  5. ZenMonkey says:

    This reminds me so much of chronic fatigue syndrome and the hysteria over XMRV.

    • Al Morrison says:

      ZenMonkey, interesting parallel. Did you think you would inspire so much…controversy with your observation?

      • ZenMonkey says:

        Well, no, I didn’t expect an uninformed bigot would weigh in with his asinine “observations” about CFS. I’m accustomed to better from the commenters on this blog, but you and the other respondents to those observations have restored my faith. ;-)

      • Max says:

        GoneWithTheWind also stated that Global Warming is a hoax, etc.

      • GoneWithTheWind says:

        Global warming is not a hoax. AGW is a hoax. This is the 33rd naturally occurring global warming cycle since the last ice age. Man did not cause the previous 32 and didn’t cause this one. It will be follwed by a naturally occurring global cooling cycle. Man will not have caused that either and won’t be able to stop it. Have you ever noticed that everyone who advocates for AGW has a solution that requires higher taxes and more restrictive laws? Why is that??? Because AGW is a socialist hoax that is intended to prepare the common man for accepting regressive taxes and loss of constitutional rights.

      • Alan says:

        Have you ever noticed that everyone who advocates for AGW has a solution that requires higher taxes and more restrictive laws? Why is that???

        Wow! AGW is just a sinister plot because — drumroll — it actually costs money to combat something affecting the whole planet? Sheesh, and here I thought we just had to hold hands and sing kumbaya to make all our troubles go away! Your powers of logical deduction are truly spectacular!

  6. GoneWithTheWind says:

    I hate myself for saying this, but… chronic fatigue syndrome is usually a sickness of older overweight women as an excuse for not working, doing housework, having sex, etc. Have you ever seen a hot 21 year old with CFS?

    • ZenMonkey says:

      Actually, yes, I have. I know many young people struggling with it. And hating yourself for saying that is a perfectly appropriate response, as it was enormously offensive.

    • Sasha Pixlee says:

      I’m reminded of someone who said, right in front of me, “I hate to say it, but we elected a communist n*****r.”

      If you really hate to say it, or hate yourself for saying it, why are you talking?

    • TonyaK says:

      GoneWithTheWind…Do you have any good research data to back up your statement, or are you merely trying to be rude and offensive?

    • JennaMarie says:

      GoneWithTheWind: Where is your evidence for this? Opinions and anecdotes aren’t helpful or scientific and can be offensive to those that are living with chronic illness like MS, CFS and FMS.

    • Al Morrison says:

      GoneWithTheWind…thank you for enlightening us with your anecdotal load of_. Lets say it were exclusively a disease of older, overweight women (which it is not, see the link below). Would that make it any less worthy of scientific investigation, and its sufferers any less worthy of empathy?

      Anyone interested in who is at risk, what the symptoms are, and what the possible treatments may be can start at this Mayo Clinic link.

      http://www.mayoclinic.com/health/chronic-fatigue-syndrome/DS00395

    • K.O. Myers says:

      GoneWithTheWind, I’d like to thank you for having the courage to post such a lazily stereotypical and deeply offensive comment. CFS is a poorly understood and frequently misdiagnosed illness. Patients often struggle even to find a physician who can understand and help them manage their symptoms. And your comment brilliantly encapsulates the dismissive and condescending prejudice that CFS sufferers often face from their friends and family, let alone the uninformed public. Today, you’ve shown that everyone can serve a purpose, even if only an appallingly bad example. Good show.

      • kabol says:

        I hate myself for saying this…

        evidently your self-hatred for saying that is shared by others. i don’t hate you, i just think you sound stupid.

      • GoneWithTheWind says:

        CFS is poorly understood simply because there is no evidence of it. Anyone can claim to have it but no amount of scientific study can find any evidence it exists. It is like religion, i.e. you have to have faith that the patient is telling you the truth. And why wouldn’t you??? It’s not as though people lie about their illness (LOL). The ONLY thing missing from this to make it the classic scam is someone to sue. If ONLY we could blame this on the workplace or having once been within a block of asbestos or something. Hmmmmm!! Wait for it… I bet someone will come up with proof that some large and rich corporation caused CFS. I see an advertising campaign by a large lawfirm asking you to sign up for the class action lawsuit. Hold on, your dreams will be answered…

      • x86dude says:

        This would have to be the most ignorant and offensive comment I have ever seen on the net.

        ME is a serious illness with many accepted bio-markers. The name of the illness was changed to Chronic Fatigue by incompetent bureaucrats and exploited by corrupt psychiatrists working for insurance companies for 20 years. It is the greatest medical abuse scandal of modern times.

        Many young people get ME. I know of an 8 year old with ME. With RnaseL activity it is clearly activated by a retrovirus. Would you lay the same abuse on an AIDS patient ?

        Scepticism is based on science. You have disgraced scepticism.

      • MadScientist says:

        Oooh – an expert – NOT. I think I hear Zamboni calling you …

      • ZenMonkey says:

        You have been asked for your citations but I see you continue not to provide them. Please link evidence of your claims. Thank you.

      • CFIDS Patient says:

        GWTW,if you think there is no evidence for CFIDS, it’s because you clearly have no interest in looking for it. Among just a few referenced examples from the CFIDS Association Website:

        http://www.cfids.org/about-cfids/research.asp

        “Immune system abnormalities have been found in CFS patients, although none has emerged as a diagnostic marker. The most common are diminished natural killer cell function8, generalized immune system upregulation9, immunological differences in cytokine patterns10 and dysfunction in the 2-5A synthetase RNase L antiviral pathway11.”

        “In 1995, Johns Hopkins researchers reported that up to 95% of CFS patients have neurally mediated hypotension, a condition in which blood pressure falls when it should rise16″

        “Scientists in the U.K. have found that CFS patients’ with low cortisol have abnormally small adrenal glands32. In CFS patients the adrenal glands were half the size of normal, while in a comparison group with depression they were enlarged up to 70%.”

        Clearly, your belief that there is no evidence for CFIDS is interfering with your ability to notice that the medical community has had evidence showing CFIDS is a biologically-based illness since the mid-90’s.

    • MadScientist says:

      Ever seen a hot 21 yo with CFS? Yes, many times; even one as young as 16 (although in that case it was bad diet, but the family wouldn’t listen so it took almost 2 years to set that one straight – poor gal). The thing with CFS is that it is “non-specific”; the people afflicted are not suffering from a single pathogen or a single type of mental problem.

    • Alex says:

      Another yes, she died from complications related to it. Not 21, but in her mid 20’s and very beautiful.

  7. Al Morrison says:

    I’m curious, in how many independent experiments does the null hypothesis have to be supported before we can reject the original hypothesis? I am (because I am not qualified or knowledgeable)not suggesting two studies reach this threshold for CCSVI. There must be a point at which we can safely say the hypothesized relationship has failed across enough varied paradigms to be deemed falsified.

    With medicine the stakes are high. One would hate to be premature and miss a potential diagnostic or treatment regimen. However, the funding is not unlimited, nor are the number of research hours.

    Both the sufferers/fundraisers and the researchers should have input; however, the question is, to what degree.

    Interested in feedback. Thanks.

    • Max says:

      It’s the null hypothesis that has to be rejected.

    • MadScientist says:

      You can’t set a number and say the original is disproven; things just don’t work that way. Think about the age-old quest to fly; even in the ancient Greek stories we hear about Icarus and yet we are only aware of gliders for a comparatively short period of those 2000+ years, ballooning is not quite 200 years old, and motorized aircraft have only been around for about 100 years. Now medical claims may be quite a different case; with what is currently known about various diseases etc., some claims are easily tested and rules out on the basis that the claims simply don’t match reality – that is the case in physics, for example, with all claims about perpetual motion machines. For most claims in science, the best thing to do is reproduce the setup and then have the original person making the claims around to help run the show, but don’t let them touch anything or play any direct part in gathering the data; such a scheme would rule out any questions of the competency of the people doing the experiment. This is usually not practical though, but competency is only relevant in rare cases where you need a lot more background understanding which your colleagues are not likely to possess – these are extremely rare cases indeed. Now with 2 negative results, if Zamboni cannot come up with a verifiable reason for the negative results, I would immediately dismiss him as a quacking crank.

    • AC says:

      I believe that the methodology for the testing wasn’t as followed by Zamboni. Partly his fault for not describing it in enough detail.

  8. kabol says:

    …new dramatic ideas in science, especially those that seem to go against established knowledge, are likely to turn out to be wrong when the dust settles.

    one reason i never take newly marketed drugs. ever.

  9. Cathy clements says:

    Back to CCSVI, what about all the people that have been treated and have seen significant improvement??

  10. Shirley Renshaw says:

    Trials and studies are done to prove or disprove a finding. To prove positive you follow proper protocols and use the correct equipment. If done accordingly it will prove true. BUT if you do not follow proper protocol and use equipment not suggested you will NEVER replicate the correct finding. CCSVI is a Vascular condition and not a Neurological one. So, an Interventional Radiologist would do the procedure and have the result showing as true. If a Neurologist does the same procedure and has very little knowledge of venous disorders these results would show false in most cases. The following is provided by Dr. Tariq Sinan. “In order to adhere to scientific method, the researchers need to replicate the original study and use Zamboni’s criteria for the diagnosis of CCSVI. Instead, the German researchers used blood flow assessment. In fact, they admit “the discrepancies between the studies may be due to the inclusion in our study of blood flow analysis.” This study does not include the use of MRV or venography technology. The fact that the researchers found only one patient out of 76 with CCSVI raises serious doubt due to the fact that we found 7% of our control group had stenosis. This paper is the only paper with such contrary results to all published papers linking CCSVI and M.S. It needs to be validated with more studies and larger numbers of patients.”
    As far as I am concerned if you do not want to find the truth you can do that quite easily by not following protocol. And on that note all testing done to discredit and minimize Dr. Zamboni results ARE NOT CREDITABLE and proves the point that Big Pharma and the Multiple Sclerosis Societies DO NOT want to find and tell the truth.

  11. Paul says:

    Remember a lot of the improvement for people who have had treatment for CCSVI could be due to the placebo effect. Remember MS is a cyclic disease where the psyche and expectation can play abig role. Also anecdotal testimony is not proof, bear in mind many MS patients claim to be cured after seeing a faith healer, see
    http:www.youtube.com/watch?v=CkuhMuKDm-o&feature=related
    for such an example.

  12. Shirley – you are assuming that CCSVI is true and therefore if a study is negative it was flawed, and positive it was correct. But who’s to say that Zamboni’s studies are not flawed and producing many false positive results?

    The techniques used by these two research groups are legitimate, and should have shown CCSVI if it existed. They call into question Zamboni’s results.

    I agree that more research should be done to put the issue to rest, at least from a scientific point of view.

    Appealing to conspiracy theories, however, is not science and not rational. It is a way of dismissing negative evidence you don’t like.

  13. Bob says:

    To the dumb ass editor. How can i believe this article when you
    state Dr. Zamboni as a neurosurgeon when he’s really a vascular surgeon.

    http://en.wikipedia.org/wiki/Paolo_Zamboni

  14. mini says:

    The problem with the two studies cited in this blog posting is that they are NOT replications of Zamboni’s study. The scientists behind these two, which can only be considered hit pieces, did not utilize the same scanning and testing protocals.

    These are neither replications nor attempts to replicate. Therefore, they are junk science based on faulty conclusions being drawn from disingenous ‘research’.

    • AC says:

      What’s more these studies came out in record time and were approved by peer-review for publication at break-neck speed as well. Usually this stuff takes forever to get published.

  15. Just because these studies were not exact replications does not mean they are “junk science”. They used established methods of evaluating venous function and found no blockage.

    The results of these studies will likely be used to design better studies and we will get more rigorous data. No one is saying this is the final word – but these studies are a note of caution that the hype surrounding CCSVI is premature.

    It is true that Zamboni is a vascular surgeon, not a neurosurgeon. That was a mistake I carried forward from another report. But it is really irrelevant to any of my points. The vasculature of the brain is something that both vascular surgeons and neurosurgeons deal with, so it is an easy mistake to make. And in any case, it is irrelevant. But at least you found a convenient excuse to dismiss data and arguments you don’t like.

  16. mini says:

    calling something this is not an exact replication an ‘exact replication’ is junk, no two ways about that, especially when referring to CCSVI, a condition that was defined by Zamboni. “They used established methods of evaluating venous function and found no blockage,” are not the same methods Zamboni used in assessing, and DEFINING, CCSVI.

  17. mini – that is largely irrelevant. You are looking for a reason to dismiss perfectly good evidence. There is no reason to think that Zamboni’s methods are the gold standard – there cannot be a gold standard when CCSVI has not yet been established. His methods may produce false positives. It makes perfect sense to use various methods to assess the question – methods that it is reasonable to expect should find evidence of CCSVI. We have to examine this question from multiple angles.

    Now we need follow up studies using more or different methods – and compare those methods to Zamboni’s. Eventually the full picture will emerge.

    But I get the sense that some people don’t want the full true scientific story – they want to grasp onto preliminary evidence of a controversial concept and them put blinders on to the full messy scientific process.

  18. derekdadey says:

    I agree with Granny Turtle, although the CCSVI seems to do alot to support people with MS I think they have some alterior motives i.e. $$$. I know the Neurologist I was (noticed was) seeing just wanted me to take Biogens. Whenever he would get all his patients together for a “talk”, he would speak for about ten minutes and then all the Biogen clients would start coming out of the woodwork. By the time the meeting was over it was clear who was flipping the bill and why. I would like to see the CCSVI start helping people who have MS blaze the trail of trying to apply for benefits before they are disabled instead of after they are layed off because they cant work anymore. Lets make this available to those who want to try it.

  19. The CCSVI Liberation Treatment could be the cure but fact remains that the rate of re-occlusion is stuck at 50% and MS patients being treated in the European and Asian countries end up suffering as they did, 3 months ago. While Big Pharmaceutical Corporations and governments in the US and Canada are coming up with new ideas to stop any advancements to the CCSVI theory (Like the superbugs, etc.), millions continue to travel to countries like India and Poland to get this simple procedure and no valuable data is recorded to support the CCSVI theory. Unless we get our position strong enough to support the CCSVI Theory, we will never be able to beat the Pharma Corporations or start the treatment here and many will keep suffering and dying even after having the procedure done. I lost my elder brother last month because of a blood clot in his stent. He got liberated 5 months ago in Poland. We need to prove to the government that this works. Non-profit organizations like the CCSVI Clinic http://www.ccsviclinic.ca/ are tirelessly working to develop safer protocols with teams of world renowned surgeons even though they are feeling the negative pressure from you know who. They have started Clinical Trials for CCSVI and we need to support these groups because they are our only hope to fight for the truth. Without the valuable data that they are collecting offshore, the procedures will not be allowed here, in our own countries.

  20. Leo Voisey says:

    Stem cells are “non-specialized” cells that have the potential to form into other types of specific cells, such as blood, muscles or nerves. They are unlike “differentiated” cells which have already become whatever organ or structure they are in the body. Stem cells are present throughout our body, but more abundant in a fetus.
    Medical researchers and scientists believe that stem cell therapy will, in the near future, advance medicine dramatically and change the course of disease treatment. This is because stem cells have the ability to grow into any kind of cell and, if transplanted into the body, will relocate to the damaged tissue, replacing it. For example, neural cells in the spinal cord, brain, optic nerves, or other parts of the central nervous system that have been injured can be replaced by injected stem cells. Various stem cell therapies are already practiced, a popular one being bone marrow transplants that are used to treat leukemia. In theory and in fact, lifeless cells anywhere in the body, no matter what the cause of the disease or injury, can be replaced with vigorous new cells because of the remarkable plasticity of stem cells. Biomed companies predict that with all of the research activity in stem cell therapy currently being directed toward the technology, a wider range of disease types including cancer, diabetes, spinal cord injury, and even multiple sclerosis will be effectively treated in the future. Recently announced trials are now underway to study both safety and efficacy of autologous stem cell transplantation in MS patients because of promising early results from previous trials.
    History
    Research into stem cells grew out of the findings of two Canadian researchers, Dr’s James Till and Ernest McCulloch at the University of Toronto in 1961. They were the first to publish their experimental results into the existence of stem cells in a scientific journal. Till and McCulloch documented the way in which embryonic stem cells differentiate themselves to become mature cell tissue. Their discovery opened the door for others to develop the first medical use of stem cells in bone marrow transplantation for leukemia. Over the next 50 years their early work has led to our current state of medical practice where modern science believes that new treatments for chronic diseases including MS, diabetes, spinal cord injuries and many more disease conditions are just around the corner.
    There are a number of sources of stem cells, namely, adult cells generally extracted from bone marrow, cord cells, extracted during pregnancy and cryogenically stored, and embryonic cells, extracted from an embryo before the cells start to differentiate. As to source and method of acquiring stem cells, harvesting autologous adult cells entails the least risk and controversy.
    Autologous stem cells are obtained from the patient’s own body; and since they are the patient’s own, autologous cells are better than both cord and embryonic sources as they perfectly match the patient’s own DNA, meaning that they will never be rejected by the patient’s immune system. Autologous transplantation is now happening therapeutically at several major sites world-wide and more studies on both safety and efficacy are finally being announced. With so many unrealized expectations of stem cell therapy, results to date have been both significant and hopeful, if taking longer than anticipated.
    What’s been the Holdup?
    Up until recently, there have been intense ethical debates about stem cells and even the studies that researchers have been allowed to do. This is because research methodology was primarily concerned with embryonic stem cells, which until recently required an aborted fetus as a source of stem cells. The topic became very much a moral dilemma and research was held up for many years in the US and Canada while political debates turned into restrictive legislation. Other countries were not as inflexible and many important research studies have been taking place elsewhere. Thankfully embryonic stem cells no longer have to be used as much more advanced and preferred methods have superseded the older technologies. While the length of time that promising research has been on hold has led many to wonder if stem cell therapy will ever be a reality for many disease types, the disputes have led to a number of important improvements in the medical technology that in the end, have satisfied both sides of the ethical issue.
    CCSVI Clinic
    CCSVI Clinic has been on the leading edge of MS treatment for the past several years. We are the only group facilitating the treatment of MS patients requiring a 10-day patient aftercare protocol following neck venous angioplasty that includes daily ultrasonography and other significant therapeutic features for the period including follow-up surgeries if indicated. There is a strict safety protocol, the results of which are the subject of an approved IRB study. The goal is to derive best practice standards from the data. With the addition of ASC transplantation, our research group has now preparing application for member status in International Cellular Medicine Society (ICMS), the globally-active non-profit organization dedicated to the improvement of cell-based medical therapies through education of physicians and researchers, patient safety, and creating universal standards. For more information please visit http://www.neurosurgeonindia.org/

  21. Leo Voisey says:

    Stem cells are “non-specialized” cells that have the potential to form into other types of specific cells, such as blood, muscles or nerves. They are unlike “differentiated” cells which have already become whatever organ or structure they are in the body. Stem cells are present throughout our body, but more abundant in a fetus.
    Medical researchers and scientists believe that stem cell therapy will, in the near future, advance medicine dramatically and change the course of disease treatment. This is because stem cells have the ability to grow into any kind of cell and, if transplanted into the body, will relocate to the damaged tissue, replacing it. For example, neural cells in the spinal cord, brain, optic nerves, or other parts of the central nervous system that have been injured can be replaced by injected stem cells. Various stem cell therapies are already practiced, a popular one being bone marrow transplants that are used to treat leukemia. In theory and in fact, lifeless cells anywhere in the body, no matter what the cause of the disease or injury, can be replaced with vigorous new cells because of the remarkable plasticity of stem cells. Biomed companies predict that with all of the research activity in stem cell therapy currently being directed toward the technology, a wider range of disease types including cancer, diabetes, spinal cord injury, and even multiple sclerosis will be effectively treated in the future. Recently announced trials are now underway to study both safety and efficacy of autologous stem cell transplantation in MS patients because of promising early results from previous trials.
    History
    Research into stem cells grew out of the findings of two Canadian researchers, Dr’s James Till and Ernest McCulloch at the University of Toronto in 1961. They were the first to publish their experimental results into the existence of stem cells in a scientific journal. Till and McCulloch documented the way in which embryonic stem cells differentiate themselves to become mature cell tissue. Their discovery opened the door for others to develop the first medical use of stem cells in bone marrow transplantation for leukemia. Over the next 50 years their early work has led to our current state of medical practice where modern science believes that new treatments for chronic diseases including MS, diabetes, spinal cord injuries and many more disease conditions are just around the corner.
    There are a number of sources of stem cells, namely, adult cells generally extracted from bone marrow, cord cells, extracted during pregnancy and cryogenically stored, and embryonic cells, extracted from an embryo before the cells start to differentiate. As to source and method of acquiring stem cells, harvesting autologous adult cells entails the least risk and controversy.
    Autologous stem cells are obtained from the patient’s own body; and since they are the patient’s own, autologous cells are better than both cord and embryonic sources as they perfectly match the patient’s own DNA, meaning that they will never be rejected by the patient’s immune system. Autologous transplantation is now happening therapeutically at several major sites world-wide and more studies on both safety and efficacy are finally being announced. With so many unrealized expectations of stem cell therapy, results to date have been both significant and hopeful, if taking longer than anticipated.
    What’s been the Holdup?
    Up until recently, there have been intense ethical debates about stem cells and even the studies that researchers have been allowed to do. This is because research methodology was primarily concerned with embryonic stem cells, which until recently required an aborted fetus as a source of stem cells. The topic became very much a moral dilemma and research was held up for many years in the US and Canada while political debates turned into restrictive legislation. Other countries were not as inflexible and many important research studies have been taking place elsewhere. Thankfully embryonic stem cells no longer have to be used as much more advanced and preferred methods have superseded the older technologies. While the length of time that promising research has been on hold has led many to wonder if stem cell therapy will ever be a reality for many disease types, the disputes have led to a number of important improvements in the medical technology that in the end, have satisfied both sides of the ethical issue.
    CCSVI Clinic
    CCSVI Clinic has been on the leading edge of MS treatment for the past several years. We are the only group facilitating the treatment of MS patients requiring a 10-day patient aftercare protocol following neck venous angioplasty that includes daily ultrasonography and other significant therapeutic features for the period including follow-up surgeries if indicated. There is a strict safety protocol, the results of which are the subject of an approved IRB study. The goal is to derive best practice standards from the data. With the addition of ASC transplantation, our research group has now preparing application for member status in International Cellular Medicine Society (ICMS), the globally-active non-profit organization dedicated to the improvement of cell-based medical therapies through education of physicians and researchers, patient safety, and creating universal standards. For more information please visit http://www.theprofitron.com/bic/