The birth of ShuntCheck: Family, love, passion, death—and ice

by Joseph Madsen on January 7, 2011

Spencer Neff, Patient #1, during his first ShuntCheck trial, Nov 2002

The year was 2002, and 10-year-old Spencer Neff was a spunky boy with hydrocephalus, a buildup of cerebrospinal fluid inside his brain. A surgically implanted shunt – a tube to drain the fluid – was in place. Like all children with shunts, he was at risk for having the shunt plug up and malfunction, and he sometimes got scary headaches. But Spencer was lucky to have a neurosurgeon uncle, Samuel Neff, who offered him an interesting proposition:  would you rather be paid to help with some research, or be a scientific collaborator?  Spencer chose the latter.

Sam had been thinking: If Spencer gets a headache, is there a way to know for sure that his shunt is plugged—without having to go to an emergency room, have x-rays and scans, and perhaps a needle puncture into the shunt? Shunt malfunction can be life-threatening—and the uncertainly can be extremely frustrating. Was there a non-invasive way to check flow in the shunt?

Sam and his son Daniel check temperature data from Spencer's shunt

Sam’s clever idea was to detect flow by chilling some of the fluid in the shunt with an ice cube, and then test downstream for a drop in temperature.  Such temperature-related tricks are used elsewhere in medicine (to measure cardiac output, for example). With his sons Daniel and Rob (then an engineering undergraduate at Drexel University), Sam made prototypes in his home shop, circuit boards, algorithms to interpret temperature changes in the skin over the shunt—and convinced himself with benchtop data and some testing on Spencer that the idea worked.

This is not the first story about inventors inspired by a child in the family with hydrocephalus. The first commercially successful shunt valve was invented by John Holter, a machinist whose child was born with hydrocephalus and spina bifida. The famous children’s author Roald Dahl (“Willie Wonka and the Chocolate Factory”) invented the Dahl shunt valve, marketed in England.

But there were twists to come. A new device, even one that is safe and works, needs to be novel enough to be patented, so that a company can profitably produce it. And it needs to be cleared by the FDA—and here being too novel, too different from what exists already—can slow things down. Sam became deeply frustrated on both counts. He was concerned that there might not be anything patentable in his gadget, and that the FDA might not be willing to approve the device.

In fact, at a national neurosurgical meeting I attended, he presented the concept and why it should work—then offered to give the devices to any neurosurgeon who might like to use them.  He thought a company would never make them.

I knew Sam casually, and talked to him privately after his presentation. I was pretty sure there would be a way to patent some aspect of the device (which is all that would be needed), and some way to get FDA approval.  I thought this could be done as a “510(k)”—a relatively fast mechanism for approving medical devices that have substantial similarity to existing devices. I prevailed upon him to try again—the gadget was too promising to throw away.

ShuntCheck test: A: Three sensors are placed over the skin and an ice cube is applied for 60 seconds. B: The area of cooled skin is shown in blue. C: The middle sensor picks up a temperature drop in the fluid downstream of the shunt.

In the end, Sam formed a company with his brother Alan (Spencer’s father) and got a patent.  Together they got 510(k) approval for the device now called ShuntCheck, and got funding to move it forward.

But here is where the story becomes very sad.

Sam did not get to see how things worked out. Quietly watching television at home one night, he suffered a myocardial infarction and died suddenly, at age 46. That same day, he had met with a very large shunt company, and it appeared that his device would be developed for widespread distribution after all.

Meanwhile, a study of 100 patients in this month’s issue of Neurosurgery, on which I was the first author, shows that ShuntCheck reliably picks up on the presence or absence of fluid flow in the shunt. But here’s a surprise: the study also found that patients can have flow in the shunt despite a genuine need to have surgery to fix the shunt—and, conversely, a patient who is not having problems, and does not need surgery, may have no detectable flow in the shunt.

This unexpected finding makes thinking about the problems of children with shunts more complicated than we might have hoped. Like many new kinds of data about patients, we need the numbers, but we also need clinical experience to know how to interpret the numbers in each patient.  Measuring shunt flow in hydrocephalus does not instantly tell us who needs surgery—but it surely is important information that will take some time to sort out.

So the research on ShuntCheck is not complete. But Spencer, now a senior in high school, is doing well. Rob, the undergrad who worked for the family company, still works in medical device engineering, and Daniel is now a medical student at Jefferson Medical College. Sam’s passion for helping his nephew lives on—and the ice and ShuntCheck are telling us things about shunts we never would have known.

Joseph Madsen, MD, is director of the Epilepsy Surgery Program in the Department of Neurosurgery at Children’s Hospital Boston, and director of the Neurodynamics Laboratory. A Very Narrow Bridge is his blog about clinical innovation and translational medicine.

20 comments

  • Parizad Bilimoria

    This is a really fascinating tale! It’s always great hearing about family members who are inspired to do research to improve treatment for their children, siblings, parents etc. How sad, though, that that in this case the inventor passed away before being able to see his technology being used widely.

    I have a question, Dr. Madsen, about the study that just came out. How do you know when “no flow” means surgery, and when it doesn’t? What are the other factors you usually consider when deciding whether to operate?

    • Patricia

      I was wondering.. can the study with the ice also be done on a VA shunt?

  • Parizad Bilimoria

    This is a really fascinating tale! It's always great hearing about family members who are inspired to do research to improve treatment for their children, siblings, parents etc. How sad, though, that that in this case the inventor passed away before being able to see his technology being used widely.

    I have a question, Dr. Madsen, about the study that just came out. How do you know when “no flow” means surgery, and when it doesn't? What are the other factors you usually consider when deciding whether to operate?

    • Patricia

      I was wondering.. can the study with the ice also be done on a VA shunt?

  • Joseph Madsen

    Let me try to answer that in two parts. For purposes of the research study, the two determinations (does the ice test show flow in this patient? does the patient go to surgery?) were made independently–the ShuntCheck result was not available to the surgeons making the decision, and the surgical findings or decision to go to surgery were not known to the software making the decision of “flow” or “no flow detected.” This was a research study to determine whether the flow findings according to the ice test predicted the need for surgery, or the findings at surgery. This “blinding” is important in evaluating the new technology.

    I think you might be asking something a little deeper: How *should* we interpret a “flow” or “flow not detected” result to help decide whether to go to surgery or not. This is what patients, parents, and doctors want to know–and this will take a bit more work to sort out. It is very important to evaluate the data carefully, and it is important not to give up too easily. We are working on this bigger question–in collaboration with the company–with an NIH funded research grant.

    Understanding the value of a new technology is a challenge. When young Dr. Harvey Cushing returned from a European tour with a new medical device–the blood pressure cuff–the American response was not enthusiastic. An expert panel from the Harvard hospitals evaluated the device, and decided that it did not add much of value to patient care.

    Even Harvard can be wrong (sometimes). We need to figure out what to do with data about shunt flow, just like we needed to figure out what to do with blood pressure measurements. This will take time, perspective, and research. You asked a good question!

  • Joseph Madsen

    Let me try to answer that in two parts. For purposes of the research study, the two determinations (does the ice test show flow in this patient? does the patient go to surgery?) were made independently–the ShuntCheck result was not available to the surgeons making the decision, and the surgical findings or decision to go to surgery were not known to the software making the decision of “flow” or “no flow detected.” This was a research study to determine whether the flow findings according to the ice test predicted the need for surgery, or the findings at surgery. This “blinding” is important in evaluating the new technology.

    I think you might be asking something a little deeper: How *should* we interpret a “flow” or “flow not detected” result to help decide whether to go to surgery or not. This is what patients, parents, and doctors want to know–and this will take a bit more work to sort out. It is very important to evaluate the data carefully, and it is important not to give up too easily. We are working on this bigger question–in collaboration with the company–with an NIH funded research grant.

    Understanding the value of a new technology is a challenge. When young Dr. Harvey Cushing returned from a European tour with a new medical device–the blood pressure cuff–the American response was not enthusiastic. An expert panel from the Harvard hospitals evaluated the device, and decided that it did not add much of value to patient care.

    Even Harvard can be wrong (sometimes). We need to figure out what to do with data about shunt flow, just like we needed to figure out what to do with blood pressure measurements. This will take time, perspective, and research. You asked a good question!

  • hydroman

    Hello Dr. Madsen,

    I became a shunted patient recently. Could you answer the following 2 questions:

    1st – How could this device (or any other test) check CSF flow in the cathedar when fluid isn’t constantly draining? For example, my shunt is a programmable shunt that only lets fluid through when the pressure gets too high. Would the ER doctor somehow have to increase my ICP to test this, and if so, how?

    2nd – Is this device available only to doctors, and if so, where?

    Thanks!

  • hydroman

    Hello Dr. Madsen,

    I became a shunted patient recently. Could you answer the following 2 questions:

    1st – How could this device (or any other test) check CSF flow in the cathedar when fluid isn't constantly draining? For example, my shunt is a programmable shunt that only lets fluid through when the pressure gets too high. Would the ER doctor somehow have to increase my ICP to test this, and if so, how?

    2nd – Is this device available only to doctors, and if so, where?

    Thanks!

  • Laurene

    Hi Dr.Madsen,

    Nice to see your work continuing! Especially when it points to a critical need for further research. Would love to discuss this more with you.

  • Laurene

    Hi Dr.Madsen,

    Nice to see your work continuing! Especially when it points to a critical need for further research. Would love to discuss this more with you.

  • Scahalan

    It was a pleasure having my daughter participate in this very important study.

    Best!

  • Scahalan

    It was a pleasure having my daughter participate in this very important study.

    Best!

  • Pilar Mª Alcántara Alcalde

    Buenas noches:

    Le escribo desde Córdoba-España.

    Tengo una niña portadora de válvula de derivación ventrículo peritoneal Syphon Guard puesta en el Hospital Virgen del Rocío de Sevilla. La estudian por el síndrome del ventrículo rígido o colapso ventricular y proponen hacerle una remodelación craneoencefálica. ¿podría decirme cómo se trata este caso en su país o a dónde debo dirigirme para saber sin hay alguna alternativa a esta intervención?

    Me gustaría también saber cómo puedo ser tratada mediante su importante invento, desde mi país.

    Gracias por su atención.

    Un saludo

    Pilar
    pilarmaria1@yahoo.es

  • Pilar Mª Alcántara Alcalde

    Buenas noches:

    Le escribo desde Córdoba-España.

    Tengo una niña portadora de válvula de derivación ventrículo peritoneal Syphon Guard puesta en el Hospital Virgen del Rocío de Sevilla. La estudian por el síndrome del ventrículo rígido o colapso ventricular y proponen hacerle una remodelación craneoencefálica. ¿podría decirme cómo se trata este caso en su país o a dónde debo dirigirme para saber sin hay alguna alternativa a esta intervención?

    Me gustaría también saber cómo puedo ser tratada mediante su importante invento, desde mi país.

    Gracias por su atención.

    Un saludo

    Pilar
    pilarmaria1@yahoo.es

  • Waaiken

    I Have A Shunt And I Get Headaches A Lot.

  • Waaiken

    I Have A Shunt And I Get Headaches A Lot.

    • Mimi90901

      I have a VP shunt, and I get lots of terible headaches too.What do do for your headaches?
      mimi90901@hotmail.com

  • martina

    my son has just had programble shunt fitted two days ago but for the last three mornings he has vomitted when he got up is the pressure starting to build again martina ireland

  • http://www.facebook.com/people/Leo-Voisey/100003645224582 Leo Voisey

    My name is David Summers of Murfreesboro, TN and I have had MS for 16 years. I am 37 years old and as of January 2012, was effectively an 8.0 on the EDSS scale. Originally RRMS, my disease progression had become SPMS (very progressive) within 4 years of onset. Normally anyone in my position and with my bleak diagnosis is limited to a short future, absolutely no quality of life and a painful end…possibly prior to my 40th birthday if the current progression of the disease continued (without the slightest hesitation or glimmer of hope, my Neurologist just told me: “ Prepare to deteriorate”). But after I heard about Dr. Zamboni’s ‘liberation therapy hypothesis’ in 2010, I began my search for the vein-widening therapy. This put me into a clinic in Duluth, Georgia where they were doing the liberation procedure. I received immediate positive results post-procedure…along with the surgeon’s warning that 50% of the MS patients who undergo the liberation therapy suffer a re-narrowing of the jugular veins within a year or so. Sure enough, within 3 months I knew that I was going to be among the unlucky 50%; all of the original improvements disappeared as I relapsed.

    I felt the only way forward was to get it done again, hopefully this time with more enduring results. But where would I go to get this done again and how would that be possible? If my neck veins restenosed after the first treatment, what was to prevent that from happening again…and again? I began to read the Internet blogs and forum chats placed on the many new CCSVI sites by MS patients about where to go and what their experiences were. In this respect, the Internet became a valuable educational tool for me. On several of the blogs, I discovered a New York clinic where they placed a stent during the procedure to keep the jugular veins open, and that positive results were being seen. Grimly, I also discovered that although rare, the prospect of death as a result of this procedure was also a risk. At least one person in a recent study had died when the stent migrated to his heart. But I was willing to put those thoughts and the risks aside. What did I really have to lose? I was dying a slow death. As long as someone was able to treat me there was a chance to hope, and I was down for it. But that wasn’t the main question I was asking myself.

    As my disease rapidly progressed and my disabilities became more overwhelming, the question I was asking myself was, was it too late for me? Although I was happy with the fact that my original liberation therapy had diminished most of the symptoms above my waist, I had to ask myself if getting stents was merely settling for a compromised improvement. Having had some success, if I had this done again, I wanted more! Don’t get me wrong, I think the liberation therapy is a miracle discovery from God. As soon as I had my first procedure my cog fog  lifted, the vision in my right eye improved greatly, the numbness in both hands dissipated by a few degrees, my ability to taste food returned, my energy levels were ’off the charts’, and  my sleep was so sweet. Also, because MS had robbed my body of the ability to regulate body temperature by sweating, I had not been able to handle the hot, humid Southern summers where I live, except to blast cold AC non-stop as a survival method during those sickly ‘dog days’. After the procedure this changed too. I knew it when deodorant suddenly became necessity for my personal hygiene once again!

    But it ended by the 90-day point and I was right back where I started. Immediately following the procedure I had dreams of rising from the wheelchair I’d been confined to for ten years and walking like a real man; but even with the incredible improvements overall, it seemed that the only healing occurred above the waist. Perhaps I would just have to accept that even if I could improve to what the full extent of the liberation therapy would allow, I would always be in a wheelchair. While researching the New York clinic and other places, my parents and I came upon CCSVI Clinic through a Google search. We discovered that they are essentially a research clinic operating under an IRB but with a major difference. For the past year, having seen even better results than just doing the liberation therapy alone, they have also been transplanting adult autologous stem cells, cultured and re-injected into the body shortly after the neck venoplasty. If I chose to go there instead of New York, the procedure would be done at CCSVI Clinic at Noble Hospital in Pune India and I would have to get there essentially as a partially paralyzed patient transported in a wheelchair. There would also be a requirement to stay in the hospital for 10-12 days. But after researching the improvements demonstrated in MS patients in stem cell clinical trials, I simply decided that as long as they would take me, nothing was going to stop me from making that trip. On calls with the clinic, it was also explained that stents were not necessary as the stem cells injected intravenously could be enough to keep my veins from restenosing. My confidence in their method increased when I discovered that Dr. Gupte, the neurosurgeon, had been transplanting autologous stem cells for 4 years for a number of different neurodegenerative conditions, including MS and based his therapies on completed stem cell trial methods done in a number of hospitals and universities outside of the US (to be absolutely sure, I confirmed this through searches on Google Scholar). He had already done over 2000 successful transplants! Regarding my communications with CCSVI Clinic, I need to confess here that we did not tell the doctors the truth originally. My mother, who arranged the treatments, told them that I was an EDSS 6.5 in order to qualify. Basically she knew that they wouldn’t accept me into the program if she said I was higher. But if they saw my actual physical condition could they refuse me on the clinic steps? I hoped not.

    So in late March it was off to India with my father who is a  strong man, and my capable assistant. We arrived on March 26, 2012, and met Surjo Banerjee, CCSVI Clinic’s Managing Director at the airport. He drove us from the airport to Pune, a surprisingly modern city just south of Mumbai. I was amazed to see that the hospital and the CCSVI Clinic itself, (a full wing of suites within the hospital complex) was as clean and modern as any hospital here in the States. After checking in with a number of other patients, I was triaged for the procedures. However, based on my new assessment, it was determined that I would need about twice the amount of stem cells that they had originally programmed, figuring my EDSS scale requirement of 6.5. But paying more was out of the question. We are not rich and had basically ‘sold the farm’ to get here in the first place, and the recommended additional stem cells were going to cost another $12,000 that we had not planned for. Not their fault…I didn’t tell them the extent of my condition in the first place. So the first miracle happened when CCSVI Clinic management offered to personally cover these additional costs. I had never even met some of them, but as a result of their generosity, I received an additional 50,000,000 mesenchymal stem cells and I cannot thank them enough for the difference they have made to my life.

    On Tuesday March 27

    , I once again had the liberation therapy followed by the harvesting of red bone marrow cells from my hip bone. The clinic has strict aftercare protocols around each type of procedure with regard to position control and movement. It didn’t much affect my activity because I was unable to move much anyway. I was supine positioned, tilted slightly head high for two days following my venoplasty and then laid out supine again, in just the opposite tilt…head-lower-than-the-body for several days following the transplants of the stem cells. I was told that this would allow the newly transplanted stem cells to filter through the full length of the nervous system and locate to the points of injury. A Doppler ultrasound of my neck veins was done every day for 10 days following my liberation procedure. This was to check for any clotting or re-narrowing of the veins which had been widened. If they clotted or restenosed at any time I was in the clinic, they would take me back into the cathlab for a re-do. Happily this wasn’t necessary.
    Following the liberation therapy, the changes within my body were just as immediate and dramatic as in my first procedure in 2010, hopefully without the fear of re-stenosis; but my ‘headspace’ almost didn’t accept it. The first time with my liberation therapy in the US, the IR found one narrowing in each jugular, the right side being more severe. This time around, two blockages were found on my right side, and again one on the left.  I have heard that second and third procedures for venous angioplasty are more difficult for the surgeons because there is more build up of scar tissue in the interior of the veins, but the medical team took their time and did a perfect job. Words cannot express the emotional joy in getting the blood flowing again and getting those symptomatic improvements back a second time!

    Four days later I underwent a lower lumbar puncture, but this time not simply to gather information on whether I have MS.  This time, stem cells cultured from my own body were on their way to do what God designed them to do, and that is to heal. For all of you that might be skeptical about this, I am here to tell you that is exactly what they are doing. The positive changes were noticed as soon as I returned to my suite in the clinic and anyone who is paralysed below the waist will understand this next part. To manoeuvre myself as I usually do, I went to pick my leg up from a sitting position and throw it in front of me. The hope here is that the ‘dead-weight’ of the leg will land just right and in a position where I can best situate myself to haul my body into a position where I can further awkwardly throw my whole body into my wheelchair. If you’ve ever seen a spinal patient do this or are unlucky enough to have to do this yourself, you know what an ugly, uncomfortable process this is. But this time the ‘throw’ of the leg proved to be an over-compensation. To my absolute shock and delight my leg lifted itself just as it’s supposed to work…without  aid from my helpful hands and placed itself exactly where my brain told it go! At first I didn’t think much of it…this was a fluke, maybe my imagination, but it was something sure not to last. But it has to this day without any hint of regression as I work out and get stronger. This was the first sign of any recovery whatsoever that has occurred below the waist in over ten years, and it happened only hours after the stem cell transplant!

    Upon returning home on April 14, 2012, I closely followed the Clinic’s physiotherapy program. Since then I have been working out at levels I had been told by my doctors here in the states would not be possible again. When exercising before I had stem cell therapy, I always had to be careful not to overdo it because I would get a sickness that sometimes lasted 2 days, completely wiping me out. This even occurred after the first liberation therapy, but no more. I’ve been working myself silly and have not yet felt sick. Real strength has returned and muscles have been popping out in places on my body where I haven’t seen them in many years. As of this writing today, and for about the last two weeks my right hand has been functioning normally in every respect. I’m not saying it has improved some, I’m saying it is now completely NORMAL!  I can hardly believe it myself.

    Since I returned, and after only one month, the positive changes have been happening regularly and most every day. Most significantly, I think, my incontinence has completely improved and I am now able to almost totally control my urinary and elimination functions. All other disabilities aside, I think that this is one of the most important deficits that anyone with MS wishes they could get back! Incontinence is so embarrassing and not having control of that particular function somehow makes you feel lesser as a person. So I’m very happy to see the improvements there. My speech is back to normal. Although I never slurred my words, the thought process was oh-so-slow. Now my words come so quickly that I sometimes find myself stumbling over them…trying to say too much at once. I can’t complain about that!

    I am convinced that CCSVI Clinic is on to important discoveries about MS. They have figured this out and are doing the sequence of therapies correctly and the addition of the stem cells completes the need to repair the nerve damage that’s been done by the disease. In retrospect what they are doing suddenly makes complete sense to me. It’s still early yet and I guess time will tell to what extent my motor functions will come back, but if the last month is any indication, it could be everything, which excites me so much. I don’t know if that’s too much to hope for, but it’s the first time in 10 years that I’ve even really allowed the thought to cross my mind. The first fleeting thoughts of this after the original liberation therapy 2 years ago weren’t realistic. The good changes didn’t last. And consider this; a few months ago, I was in a wheelchair, in a permanent brain fog losing more of my independence and quality of life on a daily basis. All I had to look forward to was a deteriorating condition where others would have to take care of my every bodily function. Now I can’t wait to wake up every morning to check myself out. If anything I’m too impatient and working out too hard. But at least I can! Given my current state of health and ability to live and  function on my own, the thing that is very certain is that I have a much better quality of life back and that wouldn’t have even been possible if it hadn’t been for the lucky discovery of CCSVI Clinic through an Internet search. My family and I will be eternally grateful for what has happened no matter how this turns out. Thanks to Dr. Gupte, the other doctors, the medical team and staff at the Clinic who made this all happen for me, I’m looking forward to each day with new health and optimism! May God Bless them all!

    I have a long way to go, but as long as my jugular veins are wide open and the stem cells continue to clean up the mess those narrowed veins left behind, and damaged nerves continue to regenerate, I believe the sky is truly the limit! My main focus at this point is not only to rebuild muscle but to get my legs to work together, which will restore my balance.

    Every day is a new gift that allows me more recovery. I can hardly wait for each morning to see the next improvement! There’s so much more happening in my body than I’ve even mentioned in this writing but I hope I’ve related the main message here…MS was my previous diagnosis.

    I will be starting a blog on my progress in a week or two if anyone wants to contact me or follow my improvement. I’m sure there are many of you out there who are skeptical or would want to know how this is going for me. I’ll post the site information back here once I have it up.The first fleeting thoughts of this after the original liberation therapy 2 years ago weren’t realistic. The good changes didn’t last. And consider this; a few months ago, I was in a wheelchair, in a permanent brain fog losing more of my independence and quality of life on a daily basis. All I had to look forward to was a deteriorating condition where others would have to take care of my every bodily function. Now I can’t wait to wake up every morning to check myself out. If anything I’m too impatient and working out too hard. But at least I can! Given my current state of health and ability to live and  function on my own, the thing that is very certain is that I have a much better quality of life back and that wouldn’t have even been possible if it hadn’t been for the lucky discovery of CCSVI Clinic through an Internet search. My family and I will be eternally grateful for what has happened no matter how this turns out. Thanks to Dr. Gupte, the other doctors, the medical team and staff at the Clinic who made this all happen for me, I’m looking forward to each day with new health and optimism! May God Bless them all!

    I have a long way to go, but as long as my jugular veins are wide open and the stem cells continue to clean up the mess those narrowed veins left behind, and damaged nerves continue to regenerate, I believe the sky is truly the limit! My main focus at this point is not only to rebuild muscle but to get my legs to work together, which will restore my balance.

    Every day is a new gift that allows me more recovery. I can hardly wait for each morning to see the next improvement! There’s so much more happening in my body than I’ve even mentioned in this writing but I hope I’ve related the main message here…MS was my previous diagnosis.

    I will be starting a blog on my progress in a week or two if anyone wants to contact me or follow my improvement. I’m sure there are many of you out there who are skeptical or would want to know how this is going for me. I’ll post the site information back here once I have it up.For more information visit our site http://davidsmsstemcelljourney.blogspot.in/

  • http://www.facebook.com/people/Leo-Voisey/100003645224582 Leo Voisey

    My name is David Summers of Murfreesboro, TN and I have had MS for 16 years. I am 37 years old and as of January 2012, was effectively an 8.0 on the EDSS scale. Originally RRMS, my disease progression had become SPMS (very progressive) within 4 years of onset. Normally anyone in my position and with my bleak diagnosis is limited to a short future, absolutely no quality of life and a painful end…possibly prior to my 40th birthday if the current progression of the disease continued (without the slightest hesitation or glimmer of hope, my Neurologist just told me: “ Prepare to deteriorate”). But after I heard about Dr. Zamboni’s ‘liberation therapy hypothesis’ in 2010, I began my search for the vein-widening therapy. This put me into a clinic in Duluth, Georgia where they were doing the liberation procedure. I received immediate positive results post-procedure…along with the surgeon’s warning that 50% of the MS patients who undergo the liberation therapy suffer a re-narrowing of the jugular veins within a year or so. Sure enough, within 3 months I knew that I was going to be among the unlucky 50%; all of the original improvements disappeared as I relapsed.

    I felt the only way forward was to get it done again, hopefully this time with more enduring results. But where would I go to get this done again and how would that be possible? If my neck veins restenosed after the first treatment, what was to prevent that from happening again…and again? I began to read the Internet blogs and forum chats placed on the many new CCSVI sites by MS patients about where to go and what their experiences were. In this respect, the Internet became a valuable educational tool for me. On several of the blogs, I discovered a New York clinic where they placed a stent during the procedure to keep the jugular veins open, and that positive results were being seen. Grimly, I also discovered that although rare, the prospect of death as a result of this procedure was also a risk. At least one person in a recent study had died when the stent migrated to his heart. But I was willing to put those thoughts and the risks aside. What did I really have to lose? I was dying a slow death. As long as someone was able to treat me there was a chance to hope, and I was down for it. But that wasn’t the main question I was asking myself.

    As my disease rapidly progressed and my disabilities became more overwhelming, the question I was asking myself was, was it too late for me? Although I was happy with the fact that my original liberation therapy had diminished most of the symptoms above my waist, I had to ask myself if getting stents was merely settling for a compromised improvement. Having had some success, if I had this done again, I wanted more! Don’t get me wrong, I think the liberation therapy is a miracle discovery from God. As soon as I had my first procedure my cog fog  lifted, the vision in my right eye improved greatly, the numbness in both hands dissipated by a few degrees, my ability to taste food returned, my energy levels were ’off the charts’, and  my sleep was so sweet. Also, because MS had robbed my body of the ability to regulate body temperature by sweating, I had not been able to handle the hot, humid Southern summers where I live, except to blast cold AC non-stop as a survival method during those sickly ‘dog days’. After the procedure this changed too. I knew it when deodorant suddenly became necessity for my personal hygiene once again!

    But it ended by the 90-day point and I was right back where I started. Immediately following the procedure I had dreams of rising from the wheelchair I’d been confined to for ten years and walking like a real man; but even with the incredible improvements overall, it seemed that the only healing occurred above the waist. Perhaps I would just have to accept that even if I could improve to what the full extent of the liberation therapy would allow, I would always be in a wheelchair. While researching the New York clinic and other places, my parents and I came upon CCSVI Clinic through a Google search. We discovered that they are essentially a research clinic operating under an IRB but with a major difference. For the past year, having seen even better results than just doing the liberation therapy alone, they have also been transplanting adult autologous stem cells, cultured and re-injected into the body shortly after the neck venoplasty. If I chose to go there instead of New York, the procedure would be done at CCSVI Clinic at Noble Hospital in Pune India and I would have to get there essentially as a partially paralyzed patient transported in a wheelchair. There would also be a requirement to stay in the hospital for 10-12 days. But after researching the improvements demonstrated in MS patients in stem cell clinical trials, I simply decided that as long as they would take me, nothing was going to stop me from making that trip. On calls with the clinic, it was also explained that stents were not necessary as the stem cells injected intravenously could be enough to keep my veins from restenosing. My confidence in their method increased when I discovered that Dr. Gupte, the neurosurgeon, had been transplanting autologous stem cells for 4 years for a number of different neurodegenerative conditions, including MS and based his therapies on completed stem cell trial methods done in a number of hospitals and universities outside of the US (to be absolutely sure, I confirmed this through searches on Google Scholar). He had already done over 2000 successful transplants! Regarding my communications with CCSVI Clinic, I need to confess here that we did not tell the doctors the truth originally. My mother, who arranged the treatments, told them that I was an EDSS 6.5 in order to qualify. Basically she knew that they wouldn’t accept me into the program if she said I was higher. But if they saw my actual physical condition could they refuse me on the clinic steps? I hoped not.

    So in late March it was off to India with my father who is a  strong man, and my capable assistant. We arrived on March 26, 2012, and met Surjo Banerjee, CCSVI Clinic’s Managing Director at the airport. He drove us from the airport to Pune, a surprisingly modern city just south of Mumbai. I was amazed to see that the hospital and the CCSVI Clinic itself, (a full wing of suites within the hospital complex) was as clean and modern as any hospital here in the States. After checking in with a number of other patients, I was triaged for the procedures. However, based on my new assessment, it was determined that I would need about twice the amount of stem cells that they had originally programmed, figuring my EDSS scale requirement of 6.5. But paying more was out of the question. We are not rich and had basically ‘sold the farm’ to get here in the first place, and the recommended additional stem cells were going to cost another $12,000 that we had not planned for. Not their fault…I didn’t tell them the extent of my condition in the first place. So the first miracle happened when CCSVI Clinic management offered to personally cover these additional costs. I had never even met some of them, but as a result of their generosity, I received an additional 50,000,000 mesenchymal stem cells and I cannot thank them enough for the difference they have made to my life.

    On Tuesday March 27

    , I once again had the liberation therapy followed by the harvesting of red bone marrow cells from my hip bone. The clinic has strict aftercare protocols around each type of procedure with regard to position control and movement. It didn’t much affect my activity because I was unable to move much anyway. I was supine positioned, tilted slightly head high for two days following my venoplasty and then laid out supine again, in just the opposite tilt…head-lower-than-the-body for several days following the transplants of the stem cells. I was told that this would allow the newly transplanted stem cells to filter through the full length of the nervous system and locate to the points of injury. A Doppler ultrasound of my neck veins was done every day for 10 days following my liberation procedure. This was to check for any clotting or re-narrowing of the veins which had been widened. If they clotted or restenosed at any time I was in the clinic, they would take me back into the cathlab for a re-do. Happily this wasn’t necessary.
    Following the liberation therapy, the changes within my body were just as immediate and dramatic as in my first procedure in 2010, hopefully without the fear of re-stenosis; but my ‘headspace’ almost didn’t accept it. The first time with my liberation therapy in the US, the IR found one narrowing in each jugular, the right side being more severe. This time around, two blockages were found on my right side, and again one on the left.  I have heard that second and third procedures for venous angioplasty are more difficult for the surgeons because there is more build up of scar tissue in the interior of the veins, but the medical team took their time and did a perfect job. Words cannot express the emotional joy in getting the blood flowing again and getting those symptomatic improvements back a second time!

    Four days later I underwent a lower lumbar puncture, but this time not simply to gather information on whether I have MS.  This time, stem cells cultured from my own body were on their way to do what God designed them to do, and that is to heal. For all of you that might be skeptical about this, I am here to tell you that is exactly what they are doing. The positive changes were noticed as soon as I returned to my suite in the clinic and anyone who is paralysed below the waist will understand this next part. To manoeuvre myself as I usually do, I went to pick my leg up from a sitting position and throw it in front of me. The hope here is that the ‘dead-weight’ of the leg will land just right and in a position where I can best situate myself to haul my body into a position where I can further awkwardly throw my whole body into my wheelchair. If you’ve ever seen a spinal patient do this or are unlucky enough to have to do this yourself, you know what an ugly, uncomfortable process this is. But this time the ‘throw’ of the leg proved to be an over-compensation. To my absolute shock and delight my leg lifted itself just as it’s supposed to work…without  aid from my helpful hands and placed itself exactly where my brain told it go! At first I didn’t think much of it…this was a fluke, maybe my imagination, but it was something sure not to last. But it has to this day without any hint of regression as I work out and get stronger. This was the first sign of any recovery whatsoever that has occurred below the waist in over ten years, and it happened only hours after the stem cell transplant!

    Upon returning home on April 14, 2012, I closely followed the Clinic’s physiotherapy program. Since then I have been working out at levels I had been told by my doctors here in the states would not be possible again. When exercising before I had stem cell therapy, I always had to be careful not to overdo it because I would get a sickness that sometimes lasted 2 days, completely wiping me out. This even occurred after the first liberation therapy, but no more. I’ve been working myself silly and have not yet felt sick. Real strength has returned and muscles have been popping out in places on my body where I haven’t seen them in many years. As of this writing today, and for about the last two weeks my right hand has been functioning normally in every respect. I’m not saying it has improved some, I’m saying it is now completely NORMAL!  I can hardly believe it myself.

    Since I returned, and after only one month, the positive changes have been happening regularly and most every day. Most significantly, I think, my incontinence has completely improved and I am now able to almost totally control my urinary and elimination functions. All other disabilities aside, I think that this is one of the most important deficits that anyone with MS wishes they could get back! Incontinence is so embarrassing and not having control of that particular function somehow makes you feel lesser as a person. So I’m very happy to see the improvements there. My speech is back to normal. Although I never slurred my words, the thought process was oh-so-slow. Now my words come so quickly that I sometimes find myself stumbling over them…trying to say too much at once. I can’t complain about that!

    I am convinced that CCSVI Clinic is on to important discoveries about MS. They have figured this out and are doing the sequence of therapies correctly and the addition of the stem cells completes the need to repair the nerve damage that’s been done by the disease. In retrospect what they are doing suddenly makes complete sense to me. It’s still early yet and I guess time will tell to what extent my motor functions will come back, but if the last month is any indication, it could be everything, which excites me so much. I don’t know if that’s too much to hope for, but it’s the first time in 10 years that I’ve even really allowed the thought to cross my mind. The first fleeting thoughts of this after the original liberation therapy 2 years ago weren’t realistic. The good changes didn’t last. And consider this; a few months ago, I was in a wheelchair, in a permanent brain fog losing more of my independence and quality of life on a daily basis. All I had to look forward to was a deteriorating condition where others would have to take care of my every bodily function. Now I can’t wait to wake up every morning to check myself out. If anything I’m too impatient and working out too hard. But at least I can! Given my current state of health and ability to live and  function on my own, the thing that is very certain is that I have a much better quality of life back and that wouldn’t have even been possible if it hadn’t been for the lucky discovery of CCSVI Clinic through an Internet search. My family and I will be eternally grateful for what has happened no matter how this turns out. Thanks to Dr. Gupte, the other doctors, the medical team and staff at the Clinic who made this all happen for me, I’m looking forward to each day with new health and optimism! May God Bless them all!

    I have a long way to go, but as long as my jugular veins are wide open and the stem cells continue to clean up the mess those narrowed veins left behind, and damaged nerves continue to regenerate, I believe the sky is truly the limit! My main focus at this point is not only to rebuild muscle but to get my legs to work together, which will restore my balance.

    Every day is a new gift that allows me more recovery. I can hardly wait for each morning to see the next improvement! There’s so much more happening in my body than I’ve even mentioned in this writing but I hope I’ve related the main message here…MS was my previous diagnosis.

    I will be starting a blog on my progress in a week or two if anyone wants to contact me or follow my improvement. I’m sure there are many of you out there who are skeptical or would want to know how this is going for me. I’ll post the site information back here once I have it up.The first fleeting thoughts of this after the original liberation therapy 2 years ago weren’t realistic. The good changes didn’t last. And consider this; a few months ago, I was in a wheelchair, in a permanent brain fog losing more of my independence and quality of life on a daily basis. All I had to look forward to was a deteriorating condition where others would have to take care of my every bodily function. Now I can’t wait to wake up every morning to check myself out. If anything I’m too impatient and working out too hard. But at least I can! Given my current state of health and ability to live and  function on my own, the thing that is very certain is that I have a much better quality of life back and that wouldn’t have even been possible if it hadn’t been for the lucky discovery of CCSVI Clinic through an Internet search. My family and I will be eternally grateful for what has happened no matter how this turns out. Thanks to Dr. Gupte, the other doctors, the medical team and staff at the Clinic who made this all happen for me, I’m looking forward to each day with new health and optimism! May God Bless them all!

    I have a long way to go, but as long as my jugular veins are wide open and the stem cells continue to clean up the mess those narrowed veins left behind, and damaged nerves continue to regenerate, I believe the sky is truly the limit! My main focus at this point is not only to rebuild muscle but to get my legs to work together, which will restore my balance.

    Every day is a new gift that allows me more recovery. I can hardly wait for each morning to see the next improvement! There’s so much more happening in my body than I’ve even mentioned in this writing but I hope I’ve related the main message here…MS was my previous diagnosis.

    I will be starting a blog on my progress in a week or two if anyone wants to contact me or follow my improvement. I’m sure there are many of you out there who are skeptical or would want to know how this is going for me. I’ll post the site information back here once I have it up.For more information visit our site http://davidsmsstemcelljourney.blogspot.in/

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