Posted by: Chris Maloney | April 22, 2012

Chronic Cerebrospinal Venous Insufficiency (CCSVI) And Multiple Sclerosis. Should MS Patients Try It?

Angulus venosus

Angulus venosus (Photo credit: Wikipedia)

When I wrote about Canada funding CCSVI treatments for Multiple Sclerosis, I figured people would be upset.  Everyone with a chronic condition wants a cure, and Liberation Therapy reverses all the current thinking about the disease.  You won’t progress, you don’t need injectable drugs, and all you need is a roto-rooter job on your head veins.

Also, as an alternative practitioner I’m supposed to be the cheerleader of all things alternative.  New miracle supplement, Rah Rah!  Cancer cure extracted from Yak feces, Sis Boom Bah!  When I dig in my heels and say no, I’m taking sides against alternative medicine.

Liberation Treatment may be helpful with some individuals who have MS.  Currently the Zamboni results for Chronic Cerebrospinal Venous Insufficiency are a hundred times better than comparable results from other centers.  That’s a bit worrying.  If the only person who could get your Ford truck up to 55 miles per gallon was the Ford salesman, and everyone else was still getting 18 miles to the gallon, you’d be concerned too.

In this case, Zamboni is recommending a fairly intrusive procedure that is not without risk.  What I said in my original post I stand by.  MS patients should exhaust non-intrusive lifestyle changes before they resort to surgical procedures.  If an MS patient has never looked at their Epstein-Barr levels or their vitamin D levels, those are much more accepted as being factors in MS that venous insufficiency.  The epidemiological evidence of MS incidence increasing as patients live farther away from the equator defies logical explanation from a vascular standpoint.  We would instead expect MS to correspond with body weight and vascular plaquing from cardiovascular disease.

As a treatment, CCSVI is largely untried for MS.  The surgeries that have been done are done for vascular treatment, and should not be interpreted as proof of their effect on MS.  Because the treatment is a surgery and not another pill or injectable the publicity is much greater than it would otherwise be.

The reality is likely going to be that CCSVI gives symptomatic relief for a very small proportion of MS patients without resolving the overall illness.  We currently are lacking in a clear international standard of CCSVI, so I would be very cautious before undergoing this procedure, getting a second opinion from two different vascular surgical practices.

As a final note, CCSVI as a cure for MS fails to address why interferon would be effective as a long-term treatment.  While I consider the research on interferon to be biased, it does show some long-term effect.  How would it resolve a vascular insufficiency?

The relevant abstracts are below.  Since we are discussing a medical matter, unfortunately any discussion needs to be tailored to medline research.  Bias, etc., exists, but without any benchmark of reliability we have no common ground upon which to base a reasonable discussion.

Funct Neurol. 2011 Oct-Dec;26(4):215-22.

Cerebrospinal fluid flow dynamics in patients with multiple sclerosis: a phase contrast magnetic resonance study.

Gorucu Y, Albayram S, Balci B, Hasiloglu ZI, Yenigul K, Yargic F, Keser Z, Kantarci F, Kiris A.

Source

Radiology Clinic, S.B. Haseki Training Hospital, Istanbul, Turkey.

Abstract

Cerebrospinal fluid (CSF) flow dynamics, which supposedly have a strong relationship with chronic cerebrospinal venous insufficiency (CCSVI), might be expected to be affected in multiple sclerosis (MS) patients. In this study, CSF flow at the level of the cerebral aqueduct was evaluated quantitatively by phase contrast magnetic resonance imaging (PC-MRI) to determine whether CSF flow dynamics are affected in MS patients. We studied 40 MS patients and 40 healthy controls using PC-MRI. We found significantly higher caudocranial (p=0.010) and craniocaudal CSF flow volumes (p=0.015) and stroke volume (p=0.010) in the MS patients compared with the controls. These findings may support the venous occlusion theory, but may also be explained by atrophy-dependent ventricular dilatation independent of the venous theory in MS patients.

PMID: 22364942

Funct Neurol. 2009 Jul-Sep;24(3):133-8.

The severity of chronic cerebrospinal venous insufficiency in patients with multiple sclerosis is related to altered cerebrospinal fluid dynamics.

Zamboni P, Menegatti E, Weinstock-Guttman B, Schirda C, Cox JL, Malagoni AM, Hojanacki D, Kennedy C, Carl E, Dwyer MG, Bergsland N, Galeotti R, Hussein S, Bartolomei I, Salvi F, Zivadinov R.

Source

Vascular Diseases Center, University of Ferrera, and Bellaria Neurosciences, Ferrara and Bologna, Italy. zmp@unife.it

Abstract

Chronic cerebrospinal venous insufficiency (CCSVI) is a vascular picture that shows a strong association with multiple sclerosis (MS). The aim of this study was to investigate the relationship between a Doppler cerebral venous hemodynamic insufficiency severity score (VHISS) and cerebrospinal fluid (CSF) flow dynamics in 16 patients presenting with CCSVI and relapsing-remitting MS (CCSVI-MS) and in eight healthy controls (HCs). The two groups (patients and controls) were evaluated using validated echo-Doppler and advanced 3T-MRI CSF flow measures. Compared with the HCs, the CCSVI-MS patients showed a significantly lower net CSF flow (p=0.027) which was highly associated with the VHISS (r=0.8280, r2=0.6855; p=0.0001). This study demonstrates that venous outflow disturbances in the form of CCSVI significantly impact on CSF pathophysiology in patients with MS.

PMID: 20018140

Expert Rev Neurother. 2011 Sep;11(9):1277-94.

Chronic cerebrospinal venous insufficiency in multiple sclerosis: diagnostic, pathogenetic, clinical and treatment perspectives.

Zivadinov R, Ramanathan M, Dolic K, Marr K, Karmon Y, Siddiqui AH, Benedict RH, Weinstock-Guttman B.

Source

Buffalo Neuroimaging Analysis Center, State University of New York, Buffalo, NY, USA. rzivadinov@bnac.net

Abstract

Chronic cerebrospinal venous insufficiency (CCSVI) was recently described in multiple sclerosis patients. CCSVI is characterized by impaired brain venous drainage due to outflow obstruction in the extracranial venous system, mostly related to anomalies in the internal jugular and azygos veins. The current CCSVI diagnosis is based on Doppler sonography of extracranial and transcranial venous hemodynamics criteria. To date, prevalence estimates of CCSVI, provided by different groups using various imaging methods of assessment, vary widely from none to 100%. There is an urgent need to define and validate the spectrum of cranial/extracranial venous anomalies and to establish reliable, diagnostic gold-standard test(s). The potential usefulness of endovascular treatment for CCSVI in multiple sclerosis patients is still unknown.

PMID: 21864074

CNS Drugs. 2011 Jan;25(1):67-88. doi: 10.2165/11206430-000000000-00000.

Interferon-β-1b: a review of its use in multiple sclerosis.

Plosker GL.

Source

Adis, a Wolters Kluwer Business, Auckland, New Zealand. demail@adis.co.nz

Abstract

Interferon-β-1b has been used as a disease-modifying therapy in multiple sclerosis (MS) for many years. Although its mechanism of action in MS has not been fully elucidated, it appears to involve immunomodulatory effects mediated by interactions with specific receptors. Large, randomized, multicentre, clinical trials of 2-3.5 years’ duration have demonstrated the efficacy of interferon-β-1b 250 μg subcutaneously every other day in patients with a first clinical event suggestive of MS (i.e. those with clinically isolated syndrome [CIS]) and in those with relapsing-remitting MS (RRMS). In terms of its efficacy on primary (or co-primary) endpoints, interferon-β-1b significantly reduced the risk of developing clinically definite MS compared with placebo in patients with CIS in the BENEFIT study. In patients with RRMS, interferon-β-1b was associated with a significantly lower annualized relapse rate and a significantly higher proportion of relapse-free patients compared with placebo in a registration trial conducted by the Interferon-β MS Study Group. The INCOMIN trial in patients with RRMS showed a significant advantage of interferon-β-1b over intramuscular interferon-β-1a in terms of the percentage of relapse- and progression-free patients and the proportion of patients without new MRI-documented lesions. Other active-comparator trials in RRMS used a variety of primary (or co-primary) endpoints and showed no significant differences between interferon-β-1b and either subcutaneous glatiramer acetate (BECOME and BEYOND trials) or subcutaneous interferon-β-1a (Danish MS Group trial) for these outcomes. In patients with secondary progressive MS (SPMS), the European Study Group showed that interferon-β-1b significantly increased the time to confirmed disease progression compared with placebo, although there was no significant between-group difference for this primary endpoint in a similar trial conducted by the North American Study Group. The studies allowed inclusion of patients with superimposed relapse, and both trials showed a significant reduction in annualized relapse rate with interferon-β-1b. The most frequently reported adverse events with interferon-β-1b are flu-like symptoms and injection-site reactions, which can usually be managed. The incidence of these adverse events generally declines markedly after the first year of treatment. Lymphopenia is the most frequently reported laboratory abnormality and occurs in the majority of patients. Depression, suicidal ideation and injection-site necrosis were the most serious adverse events reported with interferon-β-1b in clinical trials. Long-term safety data over a 16-year follow-up period showed no unexpected adverse events among patients treated with interferon-β-1b. Thus, interferon-β-1b is a well established, first-line, disease-modifying therapy that has demonstrated efficacy in newly emerging MS, RRMS and SPMS with superimposed relapse in well designed clinical trials, and has a generally manageable tolerability profile, with no unexpected adverse events after many years of follow-up.

PMID: 21128695


Responses

  1. I find your description of venous angioplasty for CCSVI: “and all you need is a roto-rooter job on your head veins” to be ignorant and fear-mongering. It is a minimally invasive procedure that only involves an injection of a catheter into the groin. It does not require general anaesthetic and only takes about an hour. As someone who has “exhausted” all forms of treatment available for me, I tried it and while I wasn’t expecting too much, just return of proper fluid flow, it was the best thing that ever happened to me in my 22-year MS “career”. Maybe I’m an “exception” as my neurologist says, but to have gone from not being able to stand without hanging onto something for 20 years, to now being able to walk several yards, unassisted, while carrying something, is fantastic! Many other improvements that maybe can’t be seen with neurological testing also mean a lot! People deserve to have the CORRECT information and the right to choose this option.

  2. Thank you for writing. Your story is very powerful, and if I were a layperson, I would be swayed by it. Unfortunately, I do not have the luxury of simply being excited by an outcome and recommending it to all my patients.

    I have taken time to educate myself on this issue. To do so, I cannot rely on positive case histories alone. I need to know if this is indeed a cure for MS. From what I have seen, we do not have a clear definition of what constitutes a need for CCSVI, we do not have long-term follow-up for what happens to people after the procedure, and we do not have a clear picture of whether or not CCSVI would be helpful for the majority of MS patients.

    Here is my second post on the topic. If you have conflicting medical data, I would be glad to see it: https://alternativendhealth.wordpress.com/2012/04/22/chronic-cerebrospinal-venous-insufficiency-ccsvi-and-multiple-sclerosis-should-ms-patients-try-it/

    So I am very pleased for your outcome, but I remain unconvinced that I should have my patients roto-rooter their head veins. And yes, I use that term because patients need to understand that increasing the pressure inside the veins can lead to hemorrhage, clotting, and long-term side effects. Using medicalese to describe the procedure or describing the procedure as “minimally invasive” does a disservice to the risks involved. Your outcome was wonderful, but there was a crash cart in the next room and medical personnel standing by in case you threw a clot or started bleeding. When you put things up inside the body there are risks. We do not do it lightly.

  3. Thank you for writing. Your story is very powerful, and if I were a layperson, I would be swayed by it. Unfortunately, I do not have the luxury of simply being excited by an outcome and recommending it to all my patients.

    I have taken time to educate myself on this issue. To do so, I cannot rely on positive case histories alone. I need to know if this is indeed a cure for MS. From what I have seen, we do not have a clear definition of what constitutes a need for CCSVI, we do not have long-term follow-up for what happens to people after the procedure, and we do not have a clear picture of whether or not CCSVI would be helpful for the majority of MS patients.

    Here is my second post on the topic. If you have conflicting medical data, I would be glad to see it: https://alternativendhealth.wordpress.com/2012/04/22/chronic-cerebrospinal-venous-insufficiency-ccsvi-and-multiple-sclerosis-should-ms-patients-try-it/

    So I am very pleased for your outcome, but I remain unconvinced that I should have my patients roto-rooter their head veins. And yes, I use that term because patients need to understand that increasing the pressure inside the veins can lead to hemorrhage, clotting, and long-term side effects. Using medicalese to describe the procedure or describing the procedure as “minimally invasive” does a disservice to the risks involved. Your outcome was wonderful, but there was a crash cart in the next room and medical personnel standing by in case you threw a clot or started bleeding. When you put things up inside the body there are risks. We do not do it lightly.

  4. CCSVI Treatment is not a cure for MS, but it is a procedure that has helped so many MS patients get relief from their symptoms, which is something that have been waiting for all their lives. There is a local clinic near me in Dayton, OH that offers the treatment and I have seen the relief the patients have gotten and it is amazing. It is not for everyone but there has been more positives not negative results. They have a patient testimonial on their website and it is amazing. It is completely up to the patient and their family to make the decision about the procedure, it is just great to see that something is being done to help MS patients. This is a link to their website.
    http://daytonir.com/LiberationTreatmentCCSVI.aspx

  5. Dear Priya Patel,

    Thanks for the link. It is a study that they are currently enrolling right now, to explore the effectiveness of CCSVI. We also get to see modern medical turf warfare in action. The head doctor is an interventional radiologist, a relatively new field, basically leapfrogging over the neurologists to head up the study. I’m sure that the positive results are those that you would hear about. It is very hard for another person to speak up and say: “it didn’t help me,” when someone else is gushing over how wonderful the procedure is. But the clinic is in the study phase, and we’ll see what the end results are.

  6. Chronic cerebrospinal venous insufficiency (CCSVI), or the pathological restriction of venous vessel discharge from the CNS has been proposed by Zamboni, et al, as having a correlative relationship to Multiple Sclerosis. From a clinical perspective, it has been demonstrated that the narrowed jugular veins in an MS patient, once widened, do affect the presenting symptoms of MS and the overall health of the patient. It has also been noted that these same veins once treated, restenose after a time in the majority of cases. Why the veins restenose is speculative. One insight, developed through practical observation, suggests that there are gaps in the therapy protocol as it is currently practiced. In general, CCSVI therapy has focused on directly treating the venous system and the stenosed veins. Several other factors that would naturally affect vein recovery have received much less consideration. As to treatment for CCSVI, it should be noted that no meaningful aftercare protocol based on evidence has been considered by the main proponents of the ‘liberation’ therapy (neck venoplasty). In fact, in all of the clinics or hospitals examined for this study, patients weren’t required to stay in the clinical setting any longer than a few hours post-procedure in most cases. Even though it has been observed to be therapeutically useful by some of the main early practitioners of the ‘liberation’ therapy, follow-up, supportive care for recovering patients post-operatively has not seriously been considered to be part of the treatment protocol. To date, follow-up care has primarily centered on when vein re-imaging should be done post-venoplasty. The fact is, by that time, most patients have restenosed (or partially restenosed) and the follow-up Doppler testing is simply detecting restenosis and retrograde flow in veins that are very much deteriorated due to scarring left by the initial procedure. This article discusses a variable approach as to a combination of safe and effective interventional therapies that have been observed to result in enduring venous drainage of the CNS to offset the destructive effects of inflammation and neurodegeneration, and to regenerate disease damaged tissue.
    As stated, it has been observed that a number of presenting symptoms of MS almost completely vanish as soon as the jugulars are widened and the flows equalize in most MS patients. Where a small number of MS patients have received no immediate benefit from the ‘liberation’ procedure, flows in subject samples have been shown not to have equalized post-procedure in these patients and therefore even a very small retrograde blood flow back to the CNS can offset the therapeutic benefits. Furthermore once the obstructed veins are further examined for hemodynamic obstruction and widened at the point of occlusion in those patients to allow full drainage, the presenting symptoms of MS retreat. This noted observation along with the large number of MS patients who have CCSVI establish a clear association of vein disease with MS, although it is clearly not the disease ‘trigger’.
    MS as a General Disease Condition
    Since keeping the jugular and azygos veins fully open is the key to reducing MS symptoms, it is of paramount importance to know what other post-procedure factors would create enduring effect in the venous drainage flow. All therapeutic modalities and interventions that could potentially affect the successful outcome of the ‘liberation’ therapy need to be included in the context of the treatment to establish which combination of therapies support the best long-term outcomes. Our own studies have so far shown that additional stem cell transplantation therapy done in a particular sequence immediately following the venoplasty, has led to increased luminal diameter and improved patency rates in the jugular veins. Since new clinical evidence also suggests there may be more than one primary cause in MS, and the need to create a multifaceted approach to therapeutically targeting MS as a general disease condition, it may not be appropriate to apply only ONE strategy. Based on the new histopathological discoveries outlined above, any advanced approach to treating MS obviously concerns itself with the reduction of the damage to the CNS, and to restore nerve function caused by neurodegeneration so as to prevent or delay onset and subsequent disability. By correlation, vascular pathology is part of this syndrome and cannot be ignored in isolation. The synthesis of therapies has demonstrated that patients treated through this protocol recover with:
    increased and faster neurologic improvement,
    enhanced angiogenesis and
    less pathological regression of the blood vessels,
    better and longer-term patency rates,
    less adverse metabolic reaction,
    much less risk of catastrophic iatrogenic injury to the veins leading to
    less intraluminal scarring and
    less risk of second, third and fourth procedures to open veins
    Also, in this way, infused stem cells may work to heal ALL damage to the veins throughout the body, and may in fact serve to reduce or eliminate additional venous disorders and co-morbidities not yet fully associated with MS (May-Thurner Syndrome, among others).
    Observational and statistical evidence from case studies into the sequential combination therapy that includes both venoplasty and stem cell transplantation has confirmed five beneficially therapeutic effects for MS:
    1) Jugular Vein Dilation Otherwise Known as Liberation Therapy. The vein dilation or venoplasty therapy provides the appropriate drainage of the CNS that prevents a retrograde pressure exertion on the myelin sheath covering the CNS. Whatever triggers the autoimmune system to turn on in people predisposed to MS, this back-pressure needs to be resolved. In case after case, the typical symptoms of MS retreat in individuals where the veins are expanded and the flow pressures are equalized. Good case study observation and statistical analysis of disability scale quantifications for subject samples taken post-procedure eliminate the biases inherent in the system to permit this statement of confirmation. (Personal Note: Some of the conjecture that passed for ‘conclusions’ in the NL study are quite frankly fraught with inherent biases.)
    2) Keeping the Neck Veins Open Long-term. Since keeping the jugular and azygos veins fully open is the key to reducing MS symptoms, it is of paramount importance to know what other post-procedure factors create enduring effect in the venous flow. For example, there is now good clinical and observational evidence to support the fact that stem cells (transplanted intravenously at the time of the venoplasty) reduce swelling, thrombin buildup, clotting and subsequent permanent intraluminal damage leading to scar tissue. As to what has already been established through clinical trials and subsequent therapeutic practice, it has been found that even in patients with severely malformed or abnormal jugular vein structure, the intravenous introduction of Mesenchymal stem cells (MSCs) post-operatively has served to repair injury attributable to venoplastic damage and desquamation of the endothelial and subendothelial cells of the interior venous lumen (tunica intima). Peak velocity, time average velocity vein area, and flow quantification have been assessed by means of echo colour Doppler at periodic intervals post-venoplasty. Significant hemodynamic improvement has been recorded at the level of the veins in the neck post-venoplasty. Moreover, this additional stem cell transplantation therapy has led to increased luminal diameter and improved patency rates demonstrating that the introduction of stem cells post-operatively significantly modifies the hemodynamics of the jugular veins more effectively than venoplasty alone.
    3) Post Procedural Monitoring to Avoid Second and Third Procedures. Having followed up with patients who had restenosed (in the dilated jugular veins) within hours, days or weeks of their procedure, discontinuance of postoperative monitoring, or even the lack of access to medical care following surgery does not seem reasonable especially given that the site of the disease is subject to iatrogenic injury (injury occurring as a result of the procedure) as well as significant postoperative complications (thrombosis/restenosis). As with any surgical procedure, healing must take place. Veins are clearly more subject to damage through invasive therapy since they are much thinner-walled, smooth, longitudinal muscle layers displaying a wider variation in anatomical structure and fragility than corresponding arteries. From subject to subject, vein walls may be thinner or more fibrous. Additionally, reasons for the stenosis may be multifactorial, and may occur, or may have existed for a very long time in many different sites along one of several veins, complicating and compromising effective treatment. Where CCSVI exists, these veins are also subject to venous disease due to chronic increased venous pressure with respect to the internal hemodynamics. Once treated, the fact that the internal structure of the veins cannot be seen to directly observe the damage and changes that have occurred within the lumen due to a mechanical venoplastic procedure does not mean that it has nevertheless occurred, and a healing process within the vein(s) will take place over the next several months or longer, post-venoplasty.
    This healing is no less complex or lengthy a process for an abnormal vein that has been significantly remodeled than it is for any other type of bodily injury. In fact, the short experience with neck venous angioplasty for CCSVI indicates that there is usually only one good chance to get it right; second procedures on the same vein due to restenosis can be very much more complicated due to inflammation and scar tissue. To avoid second procedures, the argument could be made that the patient aftercare protocol post-procedure is a form of ‘wound care’ where actions subsequent to the venoplasty must be consistent with supporting the critical initial phases of the healing process. Evidence suggests that this has been missed (or intentionally avoided) in any consideration of what the entire protocol spectrum for the ‘liberation’ treatment should be. By virtue of demonstrating CCSVI, a disease condition of the veins, subjects with MS are also at higher risk for complications due to invasive procedures. Therefore, any written protocol for the liberation therapy should certainly by definition include an ‘aftercare’ protocol similar to any other surgical intervention including monitoring post-procedure (observation and ability to image appropriately), position and movement control post-procedure, capacity and willingness to re-treat the affected veins if necessary, other therapeutic interventional strategies including stem cell transfusions directly to the venous site. The need to provide a defined aftercare protocol has been confirmed by the significant number of patients who have been tested within 24 hours of their venoplasty and have been found to have become thrombotic or restenosed at or proximal to the site of treatment. Yet up until now the clear need to monitor patients post-procedure to avoid risk of complications has not been a focus of either therapeutic practice or of the research, and at least therapeutically, has not been seen as necessary by the practitioners. This avoidance of post-procedure aftercare and lack of follow-up with MS patients just having undergone venoplasty is remarkably at odds with the evidence and consistent with the biases inherent in the current system of management of CCSVI.
    4) Stem Cells Turn Off the Over-aggressive Immune System. Mesenchymal Stem cells or MSCs actively interfere with immune tolerance. Recent studies have identified and confirmed the biochemical responses within the CNS. The mechanisms involved in MSC-mediated effects provide important insight into the pathways responsible for the therapeutic benefit observed following MSC transfusion. Once transfused, MSCs turn off the over-aggressive immune system. This immunosuppressive effect of MSCs is stimulated by IFN-γ, a dimerized soluble cytokine and other inflammatory cytokines. In short, these combinations of cytokines induce MSCs to express inducible nitric oxide synthase (iNOS) and result in production of elevated levels of Nitric Oxide, which induce immunosuppression.
    5) Stem Cells Natural Homing Characteristics to Locate and Repair Damaged Tissue. Mesenchymal Stem cells (MSCs) are known for their properties of immunomodulation, anti-apoptosis, angiogenesis, anti-scarring, homing through chemoattraction and support of growth and differentiation of stem and progenitor cells. These adherent stromal MSCs derived from bone marrow are extended in culture to generate differentiated progeny in response to a diversity of manipulative in vitro protocols (via chemical stimulation and/or use of growth factors). Once transfused in vivo, MSCs naturally localize to damaged tissue sites, and an environment is set up for regeneration and recovery of all tissue and neurons that have been damaged by disease. MSCs also secrete molecules that set up a favorable setting for tissue repair that avoids the formation of scar tissue. Where Glial scars and lesions had previously formed and where the glia actually produce factors that inhibit remyelination and axon repair, the MSCs overcome the natural inhibitors and optimize the environment for maximum regrowth potential. Immunological testing of lymphocytes and cytokines within the treated patient population has demonstrated the immediate immunomodulating results of MSCs within as early as 2-6 hours post-transplantation. The likelihood of both long-term neuroprotection and neuroregeneration by way of in vitro differentiation of MSCs into cells of the neuronal or glial lineage has been demonstrated in early clinical studies and observational case reports.
    Regarding the ‘Liberation Therapy’ in Isolation of Additional Support Strategies
    Current popular protocols for the ‘liberation’ procedure are not by themselves adequate to therapeutically benefit subject patients for symptomatic treatment outcomes for vascular and CSF mediated neurologic damage as they do not either acknowledge or guide us toward additional potentially safe and effective long-term treatment strategies. The large number of MS patients restenosing post-procedure has thus-far demonstrated a clear gap in the understanding of the CCSVI venous angioplasty therapy protocol. The CCSVI Clinic strategies account for MS as a general disease condition, sequencing the therapies for best effect:
    The CCSVI Clinic Protocol Combination Repair and Regeneration Strategy
    Marrow-derived Adult Autologous Mesenchymal Stem Cells
    Stem Cells are infused into Jugular Veins and intrathecally into CSF
    Formation of Glial and Cell Scar Tissues are Inhibited
    Supports growth and differentiation of Stem and Progenitor Cells
    Repair and Regeneration Strategy Benefits
    Permanent Remodeling and Intraluminal Repair of Diseased Veins (Angiogenesis, Anti-scarring)
    Stops new Neurogenerative Disease activity
    Blocks Neurite Outgrowth Inhibitors, increases Axonal sprouting
    Olig-1 Activation, increases OG Differentiation
    Increases Neuronal Survival and Regenesis
    Typical responsive outcomes to this therapeutic protocol are being closely followed in 28 patients at this time. One of the most disabled patient’s (EDSS 8.0) improvements have been listed below. This patient has not had any motor function or sensation below the waist for 10 years. He is now able to walk short distances, 60 days after his therapies and is seeing improvements each day:
    Common Clinical Symptoms of MS have diminished within 60 days
    Optic Neuritis (previously only 30% vision in right eye returned to 100%)
    General Weakness (return to normal, energy levels very high)
    Sensory (able to withstand hot and cold temperatures normally)
    Cognitive Dysfunction (previously significant, return to normal)
    Fatigue (Return to near-normal, some fatigue due to rapid neuronal and muscle tissue regrowth)
    Bladder Dysfunction (previously totally dysnergic, now near-normal)
    Bowel Dysfunction (previously neurogenic, now returned to normal)
    Cerebellar Dysfunction (still seen in walking gait, but improving rapidly)
    Spasticity (muscles contract and relax normally)
    Sexual Dysfunction (previously no desire or ability, now normal)
    ‘Liberation Therapy’ by itself is Not Adequate for Long-term Recovery
    A just-released 2011 study commissioned by the Newfoundland/Labrador Provincial Government regarding the benefits of ‘liberation therapy’ in a population of 30 patients showed ‘no measurable, objective benefit’, one year post-therapy. However, most participants did self-report significant improvements in their physical and psychological well-being for the first 90 days post-procedure. This observation is completely consistent with what the patients contacting CCSVI Clinic are reporting since many have now had the CCSVI procedure done ‘somewhere else’ where neither an aftercare protocol nor supplementary interventional techniques were supported. To date, all patients seeking additional therapies for CCSVI have reported that their presenting symptoms returned, mostly within the first 6 months. However, a significant number also reported that the beneficial effects of their first therapy only lasted a few days or weeks. Indeed when these individuals were subsequently re-treated at CCSVI Clinic, their MRV imaging consistently showed IJV blockages or stenoses ≥ their previous DU or MRV images. Although the NL study conjectures that such benefits (alleviation of typical presenting MS symptoms) could be the result of the placebo effect, it is not possible to make that statement. Preliminary results from the CCSVI Clinic’s own studies show that when the venous drainage flow equalized, the presenting symptoms of MS disappeared. The NL Study did not image the veins pre and post-procedure at the appropriate intervals to make comparisons, so any statement beyond their single conclusion would be not only be highly speculative, it also clearly reflects the author’s inherent bias.
    Follow-up
    The hypothesis put forward by the CCSVI Clinic research group is the guiding principle of the CCSVI Clinic’s protocol. Therefore, as more patients treated through the Clinic continue to demonstrate clinical improvement above the median indicators, the research group is working towards confirming the observational data through the feedback analysis of patient case study evidence. This will allow a prospective cohort study currently approved through an IRB application to collect data on records made available through medical files prior to the therapy protocol, at the time of the procedure, and then by regular patient follow-up (case study data). Patient registry and supervision of data is through the hospital IRB Board. The study is exclusionary (based on EDSS scoring) and only patients diagnosed with MS will qualify for the study. All qualifying patients must participate. It should be noted that all patients freely self-select the CCSVI Clinic and are not pressured into any decisions. The Clinic does not actively recruit patients and intends to seek informed consent for participation at the time of application for treatment; if informed consent is given, all individual patient data will be entered into a dedicated and aggregated database for analysis that will be published later, compliant with all relevant security and personal privacy requirements (HIPAA). All medical procedures are in accordance with with the rules and regulations approved by the International Cellular Medicine Society (ICMS), the world-wide oversight body for therapeutic transplantation of stem cells. Particular biases will be disclosed. The researchers have no financial interests in CCSVI Clinic.For more information please visit http://www.ccsviclinic.ca/?p=978

  7. That’s quite a comment!

    Reading through it, we have common relapse from CCSVI that may or may not be effectively treated by a post-CCSVI protocol. Since my understanding is that the FDA is warning against any continuing experimentation with CCSVI, it seems a bit ahead of ourselves to be discussing post-CCSVI treatment. I can’t make any statements about the effectiveness of post-CCSVI stem cell transplantation because the initial assumption: that CCSVI is a cause of MS, has yet to be proven. I have no issue with continued experimentation with CCSVI, but it is simply that, not a treatment protocol with the sort of consensus that would allow us to really get into whether or not it requires extensive post-treatment. Certainly the stories I have heard from patients do not involve extensive post-treatment and no one to this point has discussed stem cell transplantation as being necessary.


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