Sunday, April 26, 2015

Glimmers of Hope for Progressive MS: Human Stem Cell Trial, Biotin Study Both Show Efficacy

Progressive multiple sclerosis is a particularly horrendous and intractable illness. Unlike the relapsing remitting form of the disease, for which there are currently 12 approved treatment options (however imperfect these may be), there is tragically little available for progressive MS patients (one very flawed treatment option for SPMS and none for PPMS). At the recent American Academy of Neurology meetings, held last week in Washington DC, some rays of hope for progressive MS finally shone through, among them studies done on honest-to-goodness human progressive MS patients – as opposed to those done on mice or in test tubes – that show particular promise.

As I’ve written about extensively (click here ), the Tisch MS Research Center of New York is currently conducting the only FDA approved regenerative human stem cell trial on MS patients in the United States. Yes, this is the very same study that the National Multiple Sclerosis Society has repeatedly refused to fund (click here). Though this phase 1 trial is not yet complete, interim results were released at the AAN meeting, and they look impressive.

The Tisch Center utilizes a unique approach to using stem cells to treat MS, quite unlike the techniques used in previous regenerative stem cell trials or the stem cell treatments being offered by for-profit operations scattered around the world. Employing proprietary methodology developed in the Tisch Center’s research laboratories, raw mesenchymal stem cells – harvested from each patient’s bone marrow – are transformed into stem cells specific to the human nervous system, called neural progenitor cells. The 20 patients enrolled in this early stage trial will each receive three spinal (intrathecal) injections of neural progenitor cells, spaced three months apart. The interim results released last week report on the nine patients who have thus far begun treatment (click here).

Of these nine patients, seven displayed some form of disease improvement. Six of these seven patients suffer from SPMS, and one from PPMS. Based on neurologic exams, five of these seven patients displayed improved motor functions, including better balance, increase muscle strength, and improved ambulation. Six of the patients reported better bladder function. No significant adverse events were reported. Here’s a graphic detailing the Tisch Center stem cell trial results on a patient by patient basis, taken from the poster presented at the AAN meetings. To view the full poster, please (click here).


While exciting, it’s important to keep these results in perspective. We’re looking at a very small patient population taking part in an early phase 1 trial whose primary endpoint is establishing the safety of the treatment. That said, given the intractability of progressive MS, seeing any significant improvement is extremely encouraging, and these early results certainly validate the approach to regenerative stem cell therapy being taken by the Tisch Center.

Alarmingly, though, the Tisch Center is now facing a fund-raising crisis that threatens to impede the phase 2 extension of this study, as well as much of the other groundbreaking MS research currently underway in the Tisch laboratories. In previous posts I’ve expressed my extreme distress at the NMSS’s repeated refusals to fund research being done at the Tisch Center, and due to unforeseen circumstances the Center’s funding shortfall is now being felt quite acutely. The animal research laboratory used by Tisch Center scientists is being closed as a result of the sale of the hospital in which it’s located (only a block away from the Tisch MS Center), leaving the Center with no viable alternative other than constructing their own facility, which will require a massive fund-raising effort.

Since I’d rather this post concentrate on the research itself, I urge all readers to click here for more information regarding this fund-raising crunch, and to spread the word far and wide. While the Tisch Center is actively conducting the only current FDA approved MS stem cell trial on human beings, the NMSS funds preclinical stem cell experiments being done in test tubes and on mice that, even if spectacularly successful, won’t reach MS patients for more than a decade. Just saying…

(Full disclosure: I am a patient at the MS clinic directly associated with the Tisch MS Research Center of New York, and my MS as well as other physical ailments have been totally kicking my ass lately. So, yeah, I might take this crap just a wee bit personally.)

Another much-anticipated study presented at last week’s AAN conference provided yet more hope for progressive MS patients, though perhaps not as much as originally anticipated. The French pharmaceutical company MedDay released the results of a stage III clinical trial involving the use of massive doses of Biotin to treat patients with Primary Progressive Multiple Sclerosis (PPMS) and Secondary Progressive Multiple Sclerosis (SPMS).

Biotin (vitamin B7, also known As Vitamin H or Coenzyme R) has been used in much lower doses as an over-the-counter “nutraceutical” supplement to treat brittle hair and nails, some skin conditions, and neuropathy brought on by type II diabetes, among other applications (click here). Biotin is known to be necessary for cell growth, the production of fatty acids, and the metabolism of fats and amino acids (click here).

A small pilot study researching the use of high doses of Biotin to treat MS was conducted by MedDay starting in 2013. This initial study produced astounding results, with 91.3% of the 23 progressive MS patients involved displaying improvements in their neurologic condition (click here). This small, unblinded, non-placebo-controlled trial created much excitement, leaving patients and researchers awaiting the results of a much larger placebo-controlled phase 3 trial, which was completed in late 2014. The results of this phase 3 trial were presented at the AAN conferences on Friday, April 24, 2015.

In this late stage study, conducted at 19 centers around France, patients were given 300 mg of Biotin per day, which is the equivalent of approximately 10,000 times the maximum daily recommended dosage. The study involved 154 patients, 103 given Biotin and 51 given a placebo. The results of this study (click here), while positive, don’t appear to be nearly as compelling as had been anticipated based on the early pilot study results.

The results of MedDay’s late stage study revealed that after 12 months, 12.3% of the Biotin treated patients displayed a verified improvement in disability scores, as opposed to 0% of the placebo group. Secondarily, 4% of Biotin treated patients displayed disease progression after one year, versus 13% in the placebo group. Very few adverse events, all considered non-serious, were reported. While these numbers pale in comparison with those seen in the initial pilot study, they still represent a breakthrough of sorts in treating advanced progressive MS, which thus far has defied almost all attempts at treatment.

Looked at another way, about 1 in 8 patients treated with Biotin saw their disability scores improve, while 1 in 25 saw their disease progress. Interestingly, only 1 in 8 (I’m using ballpark figures here) untreated patients experienced disease progression. While these aren’t the kind of results many hoped for based on the early Biotin study results (9 in 10 patients experiencing neurologic improvement), they are still better than nothing, which is what mainstream medicine currently offers patients with advanced (non-relapsing) progressive MS.

Given these factors, many patients with progressive MS (myself included) have expressed great interest in giving Biotin a try, especially since the stuff is readily available in over-the-counter form. The highest dose capsules commercially available are 10 mg, meaning that a patient would need to take 30 capsules a day to replicate the doses used in MedDay’s trials, which administered 100 mg of biotin three times a day. There are a few serious problems with this approach, though, above and beyond the huge amount of capsules that would need to be ingested to replicate the doses used in MedDay’s trial.

First, the compound used in the MedDay trial is a highly concentrated and purified pharmaceutical grade form of Biotin called D-Biotin, a stereoisomer of Biotin that is extremely bioavailable (easily absorbed by the body) and contains active enzymes (click here). This type of Biotin is generally not available in over-the-counter capsules. Second, over-the-counter nutraceuticals are completely unregulated, and it’s almost impossible to know the purity of the compounds contained within the capsules or what other ingredients might also be present. One study found that a shocking one third of herbal supplements tested contained not a trace of primary ingredient the listed on the bottle (click here)! Additionally, some Biotin supplements contain calcium, which if taken in greater amounts can cause hypercalcemia, a potentially very serious medical condition (click here).

After consulting with a naturopathic physician, I'm looking into procuring ultra high grade, USP certified (click here) D-Biotin from a reputable wholesaler and having it put into properly dosed capsules through a compounding pharmacy (I'm doing this with my naturopath's help, of course, and will need a prescription in order to get the drug). While this approach is likely to be much more expensive than using over-the-counter product (probably about $300-$400/month), it will offer the best chance at replicating MedDay’s trials, and would certainly eliminate the vast uncertainties involved in consuming huge quantities of over-the-counter nutraceutical supplements.

So, there you have it, two clinical trials targeting progressive MS in very different ways, but coming up with encouraging results to one degree or another. While the Tisch Center stem cell therapy is still in early trials and is at least several years away from moving from the experimental stage to general clinical use, MedDay’s Biotin compound should be ready for FDA approval by the end of this year, and highly motivated patients might try to get a head start on things by taking matters into their own hands. Although the results of MedDay’s late stage phase 3 trial were a bit underwhelming, they do represent an important advance over the status quo, and many progressive MS patients are well past the “any port in a storm” stage.

As mentioned above, though, please take caution if you plan on going the over-the-counter Biotin route. Here’s a video featuring the terrific John Oliver explaining in his usual brilliant and sardonic fashion the pitfalls and perils of placing your trust in the nutritional supplements industry. If you are planning on trying over-the-counter biotin in the quantities required by the MedDay trial, this is an absolute must watch:

81 comments:

  1. You are much more careful than I am. I've considered the risk of being negatively impacted by the inactives in OTC biotin but I'm going for it. I have opted for brands with less harmful inactives. I'm also taking 20 x 10 mg daily (less than 300)

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    1. Wishing you the best of luck. If possible, try to procure capsules that contain only D biotin, as this is what was used in the MedDay trials. Capsules of plain old biotin will only contain a small fraction of D biotin, which means you would have to take a much greater amount to achieve a dosage similar to the MedDay trials.

      Thanks for commenting, and please let us know how it goes…

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  2. http://www.doctorvitaminstore.com/003263SuperBiotin10000Pg2.html

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    1. This does look like the right stuff, if only we can trust the label. Given the publicity the MedDay study has generated, I wouldn't be surprised to see more and more companies offering bottles labeled "D biotin", regardless of what's actually inside. Sorry for being such a cynic, but as carpenters say, "measure twice, cut once"…

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  3. Great and very informative article as usual Marc. Thank you.
    But, reading this and the outcome of these studies all my mind was saying ... These numbers and results remind me of the CCSVI struggles. The findings for CCSVI are classified as subjective and anecdotal. Even though not one neurologist followed the CCSVI protocol to come up with proper results. I know, I know there are some who did not have results including you from this treatment. Many factors could contribute to this ... Lyme Disease and Co-Infections, Biofilms, Candida to name a few. http://youtu.be/vpKkaQbbVBU. There are many who have after CCSVI treatment. Me included and still do after five years. The Biotin results I find insignificant compared to CCSVI results. Unfortunately I cannot give you their findings because it has not been studied to the ANNs liking. Of course Biotin is a DRUG once again ... which is all that this organization seem to look at. As per the stem cell study ... how many more decades before they find that Golden treatment? Until then stem cell studied by the ANN will only go on for decades more. I call this milking the system and continuously giving false hope. Lots of lip service not much action at the patients expense.
    The findings of both these studies are basically anecdotal and subjective opinions by those who have had symptom relief or better results from CCSVI treatment.

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    1. Hi Shirley, I'm sorry, but I must disagree. The MedDay study is a double blinded, placebo-controlled study done across 19 treatment centers, using tried-and-true scientific methodology. The evidence presented is anything but "anecdotal".

      As for CCSVI, I was one of the first to write about Zamboni's work outside of Internet forums. Unfortunately, the reality of CCSVI did not live up to the hype for the large majority of patients who tried it. Far more saw little or no relief then those who saw lasting improvement after undergoing CCSVI angioplasty. Although you don't see their stories on the Internet, as most who consider themselves treatment "failures" don't go on Internet or Facebook pages to shout about their experiences, I received dozens and dozens of emails from folks who were treated for CCSVI and were left extremely disappointed.

      Not to say that there isn't anything to CCSVI, or that the theory and treatment methods don't cry out for further study. However, I do sit on the patient advisory board of the Buffalo Neuroimaging Analysis Center, run by Dr. Robert Zivadinov, which has done extensive studies on CCSVI. All of their accumulated data indicates that CCSVI is not the cause of MS, but could provide symptom relief, especially for those symptoms related to the autonomic nervous system. This is not insignificant, as for some patients this symptom relief provided is significant and durable. Additionally, vascular issues have been connected with other neurologic diseases, and this area of research does hold much promise.

      I'm sure that vascular issues do play some role in the MS disease puzzle. It's a shame that the hype got ahead of the science, but there are still responsible researchers looking into the vascular connection to neurologic diseases (such as those at BNAC).

      It's vitally important, though, to not mistake anecdotal information with data gleaned from scientifically rigid studies. The anecdotal information patients read on the Internet tends to be extremely one-sided, for, as I've already noted, patients with positive stories to tell are much more likely to trumpet their experiences than patients who met with disappointment. This goes not only for CCSVI but all manner of alternative treatments.

      Regarding the Tisch center stem cell study, this trial is already underway using real-life human MS patients. If this and subsequent studies done by the Tisch center replicate the initial results, the treatment protocol may be available to patients in a relatively short timeframe (say, 3-7 years). Not soon enough, for sure, but doing real science takes time…

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    2. Appreciate your response Marc. Thank you. I am looking forward to the outcome of Biotin for us who have progressive MS. Hopefully by end of the year.

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  4. Great clip from John Oliver and I hope some folks I know who are considering taking cheap supplements will think again.

    There must be a group or lab that tests supplements; I know I read some reports maybe 10 yrs ago and made decisions I'm still using for where to buy stuff. But now I can't remember what it was. Do you know, Marc?

    Bummer on the animal lab closing.Hope this can be resolved fast as they are doing such important work. Are you being considered for or considering getting into that trial?

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    1. Hi Daphne, I think there is an industry self policing group, but I'm not sure how stringent their standards are. The situation involving nutritional supplements is quite frustrating, as how is one to know if what they are taking is effective if you can't be sure that what's in the bottle is what it says on the bottle? Just another example of the insane medical system that has evolved over the last couple of decades.

      I know the folks at the Tisch center or working extremely hard to procure the necessary funding to keep their research going. I'm not being considered for the trial because my disease is so complicated and atypical. As I've said before, in my case PPMS stands for "Peculiar Paralysis of Marc Stecker"…

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  5. A company who makes this, and options of trying
    http://www.foodchemadditives.com/products/d-biotin

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    1. Careful, not all wholesalers are created equal. The one you linked to is a Chinese company, and many Chinese chemical companies have unfortunately been linked to all kinds of shenanigans. When looking for a wholesaler, try to find one that provides USP pharmaceutical grade product. You can't be too careful…

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  6. You can purchase USP, high grade pure biotin from a certified pharma lab in a powder form in bulk. The dosage to take would be about 1 gram over a 3 day period. You could purchase around 50 g in a bulk purchase which would last you about 5 months and your cost per month would be fairly small. For daily dosing, you could measure out your 1/3 gram each day in a microgram scale, mix it up with a nice cup of water (it is water soluble and has no real taste) and sip on the glass of water throughout the day. This is the cost effective, low-tech way to get in a high amount of biotin daily and perhaps maximize absorption.

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    1. Thanks for your comment and advice. The legitimate wholesalers I've found sell pharmaceutical grade D biotin for about $75 a gram, though my naturopath think she may have located a wholesale of the charges somewhat less than this. Even so, the cost would remain considerable. Remember, you're looking specifically for D biotin, not just biotin. There are important differences.

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  7. Turns out that only 2 of the 4 brands (the most expensive two 😞 are d- biotin.

    Details here:

    http://enhancedbiotintrial.blogspot.com/2015/04/which-biotins.html?showComment=1430204676076&m=1

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  8. Just for anyone's fyi - Puritan's Pride (a mail order vitamin seller with a good rep) is selling d-biotin very inexpensively. About $5.00 for two 10,000 mcg bottles of 50 each, with free shipping.

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  9. Anonymous: It doesn't specify on Puritan's Pride website if the Biotin is d-biotin or not.

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    1. brownhair - I have a bottle in front of me - it does say d-biotin on the back. If you go to Puritan's website, you can get close up views of the back of the bottle.

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    2. Once again, I'd remind everybody to be careful. Puritans Pride does have a good reputation, but it's doubtful that what's contained in the pills is USP certified pharmaceutical grade biotin. Don't want to discourage anybody from trying, but do know what you're getting yourself into. A good friend of mine recently tried some of the over-the-counter stuff and wound up with a horrible case of diarrhea. Probably because of whatever was used as a filler…

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  10. Lots of great bits and pieces here Marc, thanks for all the work, and for having a spot where I can say thank you to all the generous folks hitting 'publish' with more bits. Thank you! This road trip benefits from lots of roadsigns.

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    1. Yes Tom, it is great that so many people are commenting with their own pieces of the puzzle. It is indeed a winding road, and there's lots of fog for the headlights to cut through…

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  11. Excellent blog, as always! I am thrilled to see these results, and it is amazing to think that something as simple as biotin may be of help. Thank you for keeping us on the cutting edge of research!

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    1. You're very welcome, Meagan. I'm grateful to all of my readers who have helped make this blog a success, and whose comments are really its lifeblood…

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  12. Mark
    On the subject of stem cells etc
    What do you make of the recent releases of reports into succes in treating progresive Ms with Hsct?
    Some reports showing a 70% success rate of progression free after 4 years follow up
    they are saying better prognosis is younger age, lower edss and earlier in the disease

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    1. Hi, I plan on writing another piece on HSCT, probably as my next blog post. I've been reading all of the recent research, and the only study I came up with that looked at progressive patients was out of Moscow. I was quite excited when I read the abstract, which does state that they had success with progressive MS patients. I was so excited, in fact, that I asked a doctor friend of mine to get me the full paper. Unfortunately, the full paper is riddled with inconsistencies, and provides very little background info on the patients who were treated, primarily because very little background info appears to have been collected. It's impossible to tell whether or not the progressive patients treated had signs of active inflammatory disease (enhancing lesions), and even though the study does state some statistics indicating success with progressive patients, in other sections it clearly states that HSCT works significantly better on RRMS patients showing signs of highly active inflammatory disease. I will go into detail on this in my HSCT blog post…

      Remember, also, that progressive MS is a very tricky disease to quantify. Or, rather, the disease progression involved with progressive MS is difficult to quantify. This is illustrated very well by the MedDay biotin study, which found that only 13% of untreated patients had progressed during the one-year trial. One would have expected that number to be much higher, but the same phenomenon shows up time and time again in trials and studies involving progressive MS patients. Quite often, the studies are deemed a failure because the placebo group does much better than the researchers expected, invalidating the results obtained on the treated group.

      All of that said, it's terribly unfortunate that there isn't more current research being done on HSCT and progressive MS. Protocols have been refined over the last several years, and perhaps would be more successful than the ones used earlier. Based on all the research that I've read, it definitely looks like that most durable and pronounced effects of HSCT apply to those who receive the treatment while suffering from active inflammatory disease. There appears to be some other element driving the disease in later stage progressive MS patients, some neurodegenerative process that is divorced from the immune system at large. This is why the newer immunosuppressant drugs that are so effective in treating early-stage MS are useless when it comes to nonrelapsing progressive MSers. Very frustrating…

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    2. Hi mark
      I agree with what your saying and it's hard when looking at the Russian results as its all done as a marketing ploy possibly, then the blogs of people having been there look to be sponsored too
      But If someone were young with rapidly progressive Ms in their early 30s what would you suggest?
      Is MSCT a better option as it has the potential to repair aswell as modulate? I know your a fan of the tisch center studies, does this seem a better option?
      Also I know after hsct MSCT is not an option, but after msct, you can continue with hsct a year later
      What's your thoughts ?

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    3. Mark also, I had contacted Israel regarding MSCT which seems to be the same protocol, then contact Dr Freedman who is involved with some of the trials who I know holds Dr Slavin in very high regard and suggested that would be an option if a trial was not
      What do you think of the Israel treatment? It is essentially the same treatment by all accounts

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    4. Hi, please remember that I am NOT a doctor, and keep that in mind as I voice my opinions. You say you have aggressive MS, but do you have aggressive relapsing MS or aggressive progressive MS? If you are relapsing, you might seriously consider one of the highly effective disease modifying drugs, such as Tysabri. I know these drugs have been given a very bad rap in some circles, but the science shows us that they can indeed be quite effective for patients with aggressive relapsing MS (even for those with not so aggressive relapsing MS). Of course, they have their downsides, especially if one is JC virus positive. Given the science and statistics, if you have RRMS and are JC virus negative, going on a drug like Tysabri should be very seriously considered, even if just as a steppingstone until HSCT becomes more widely available and is covered by insurance, which I expect should happen within the next 3-5 years.

      As for mesenchymal stem cell therapy, please keep in mind that this therapy is quite likely not a "one-shot" deal. All indications suggest that for a patient to retain any benefits seen from mesenchymal stem cell therapy they would need to undergo a series of treatments, perhaps a perpetual series of treatments. The effects of mesenchymal stem cells wear off after a few months, so unless you are able to afford multiple treatments the cost/benefit ratio may not be in your favor. Of course, this is for every patient to ascertain based on their own situations.

      I do believe that what Dr. Slavin is doing is on par with the mesenchymal stem cell trial now getting underway in Canada. You might also want to check out Celltex, a US company that performs the actual stem cell treatments in Mexico. Again, most of the patients I know who have gone to Israel or Mexico for treatment and have seen success wind up going back for repeated treatments. Don't go into this thinking that you'll get one stem cell treatment and all will be good. The initial Tisch Center trial is using a series of three treatments for a reason.

      As you state, getting mesenchymal stem cell therapy should not be an impediment to your getting HSCT somewhere down the line.

      Wishing you the best of luck as you move forward…

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    5. Hi Mark
      Thabkyou for all this its really appreciated
      It looks like progressive Ms as other than lhermittes remitting, and some sensory sympotms lessening, the spasticity has increased and progressed to issues with legs and arms
      I agree with you on MSCT and wonder whether that should be the first option and if no luck then hsct?
      I've been reading a lot about testosterone being neuroprotective too, it's something you mentioned on thisisms forum about 8 years ago I think
      There's been more studies showing it lowers grey matter atrophy to normal levels and even improves grey matter volume
      There's also a trial being done In ucla for spms rrms and Ppms patients over 96 weeks testing the effects
      It's also Been indicated to help Alzheimer's and in mouse models of spinal issues?
      Might be worth a look what are your thoughts

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    6. Hi, it's important that you look at mesenchymal stem cell therapy and HSCT as to entirely different approaches. If you do have purely progressive disease there is a much lesser chance of HSCT giving you any significant durable benefit. If you do show signs of active inflammatory disease, though, HSCT should certainly be an option. But remember, HSCT does not preclude MSCT, and vice versa.

      HSCT holds the promise of resetting the immune system and perhaps putting active inflammatory disease into remission for years at a time. Mesenchymal stem cell therapy is geared more towards repairing the damage done by the disease rather than stopping the disease process itself. In an ideal world, I suppose the best scenario for a patient with active relapsing remitting disease would be to have HSCT to halt the disease process, followed by mesenchymal stem cell therapy to try to fix the damage that has already been done.

      Remember, these are both still very experimental therapies, especially mesenchymal stem cell therapy. HSCT has been used in various forms to treat blood cancers for decades, but mesenchymal stem cell therapy is a literal babe in the woods. Both hold tremendous promise, but HSCT is much, much closer to becoming an accepted part of MS treatment.

      As for testosterone, I'm personally on it because I have a whole host of endocrine dysfunctions, among them low testosterone. I developed testosterone deficiency several years before I showed signs of MS. Whether one had anything to do with the other I suppose I'll never know. The research into the testosterone-MS connection is intriguing, as is the connection between MS and estrogen. My best advice would be to get your hormone levels checked and go from there. Hormone replacement therapy shouldn't be attempted on your own, as there could be significant dangers involved. Again, the evidence is intriguing, but nothing has yet been proven…

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    7. Matt
      What dosage of the testosterone are you on? I wonder if you have noticed any difference on it at all?
      At worse it can help with muscla atrophy and other such side effects I guess
      I've got my levels being tested tomorrow so I'll be interested to see how they work out, Dr Voskuhl had suggested 10mg in order to get the best possible dosage
      It makes sense with all the links between pregnancy and women's monthly times etc that there is hormone issues at play,
      I can't help but think that with all these different issues within ms it has to be a big DNa gene issue at play in the big picture
      Or like has been said before, EBV issues

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    8. My dosage has varied, depending on what my blood tests have shown. Keep in mind, I was testosterone deficient due to some widespread endocrine dysfunction I suffer from, so I'm not taking a testosterone as an MS treatment. That said, I haven't really seen it have any positive effects of my MS, but I'm probably not a good example to go by.

      I agree, there is probably a complex interplay of genetic predisposition to the disease in addition to exposure to environmental elements (viruses, bacteria, or toxins) that lead to the disease. There is also strong evidence that hormones play some kind of role, at least in moderating disease severity. Could this be because the disease can affect the hypothalamus and the pituitary, which control endocrine function? In my case, the doctors strongly believe that some autoimmune process damaged my pituitary gland, leading to all of my endocrine crap…

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    9. Do you think HSCT is even an option for RPMS? I have just been confirmed RPMS, and there is NOTHING out there for me...my neuro wants to try Lemtrada as she thinks it will help with the relapses, but it wont do anything for the progressive part. Her reason for wanting to try something is I am 45 and have young children I now have difficulty caring for.

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    10. Well, since by definition progressive relapsing disease includes relapses, which would infer some immune system related inflammatory activity, I would think that HSCT might be helpful. Unfortunately, many neurologists seem to be resistant to HSCT, and I'm hearing that many are steering patients towards Lemtrada. Although Lemtrada is kind of like HSCT light, or HSCT in a bottle, it does carry with it the possibility of some troublesome side effects, primarily other autoimmune diseases. These same problems can be faced in HSCT as well, but to a much lesser extent.

      Since progressive relapsing MS is one of the most infrequently seen forms of the disease, I'm not sure there's much experience in using many treatments on it. I'm a little bit puzzled as to why your doctor would say Lemtrada would help with the relapses but not the progression, because, in theory at least, if even some of your progression is being driven by immune system related inflammation, Lemtrada should have some affect on it. Of course, since the underlying disease process is so poorly understood, especially in the progressive forms of the disease, I don't think anything anybody says is much better than educated guesswork. Wishing you the best…

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  13. You raise a great point regarding the relatively low percentage of progressing placebo patients - our methods of measuring progression aren't very precise. Since the percentage of patients with improvements in the d-biotin group is roughly the same (12.6%), we might say that d-biotin reverses the effects of progressive MS. I imagine the reversal may plateau, however. It seems like it will help rebuild myelin. I don't know if any of its mechanisms help regrow nerves that are damaged. Rebuilding myelin should halt further progression, which was also seen in the d-biotin group.

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    1. Agreed. I'm not sure that the mechanism of biotin would be remyelination, seems more in line with combating the effects of oxidative stress and increasing the metabolic characteristics of mitochondria, which should inhibit the neurodegenerative process. Just conjecturing here, but the reversal of disability seen in some biotin treated patients may be due to the body having reparative properties that are able to take hold in the absence of active neurodegeneration.

      The difficulty in measuring progression is a huge problem for researchers. I know that there are many laboratories working on finding biomarkers in the CSF or serum that would help such assessments. Another metric may be the rate of brain atrophy. Relying strictly on EDSS scores or patient reports of progression is probably an exercise in futility.

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  14. Nudge your neurologist into a 300mg script of d-Biotin prescription grade pure. Not easy for the pharmacy to find/fill but they can, that's their job. Neuros of progressive MS patients can't give us anything and they think it sucks too. Just ask. My opinion.

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    1. The key is finding compounding pharmacies that are able to provide pharmaceutical grade D biotin. I think it will be up to neuros and/or patience to find wholesalers to provide the appropriate material, and then find compounding pharmacies to order the stuff and have it put into 100 mg capsules (which would be taken 3X a day). I'm afraid this will have to be a grassroots movement for now… And, yes, a prescription from an M.D. will be necessary to get the product…

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    2. Trying exactly what you laid out right now. We'll see!

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  15. Hello,

    I think what you're doing on this blog is amazing. I wanted to reach out because I'm part of a group of students at Harvard Business School who are launching a medical accessories company. Our aim is to infuse dignity into the patient experience by designing medical products that are both functional AND design-focused for patients with chronic illnesses or disabilities. To that effect, we've published an opinion piece on OpEd space here: http://opedspace.com/2015/04/23/how-companies-are-giving-patients-back-their-dignity/.

    You can see our website at www.blackpebblemedical.com for an introduction to our first product, a bag for carrying self-catheterization supplies. We believe this bag can help many self-catheterizing MS patients better carry their cath supplies in a safe, easy, and discreet way.

    We are so inspired by your blog and your work, and would be honored with an opportunity to connect with you and get your advice on how to spread the word about our product and mission. Please let me know if you would be willing to chat. I'm reachable at ablankmeyer@mba2016.hbs.edu.

    Thank you!
    Andrea

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    1. Just tried to send you an email, but got a "recipient not found" response. Are you sure the email address you supplied is correct?

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  16. I Think you folks should be reading IAGIM Drug Development Associations GLIMER I II III Study on MS written by the epidemiologist who was key to the TEVA development of CopaxoneTM. Neuro-Immuno Epidemiologist Jeremy D Block has quietly being investigation all four major types of MS and has come up with some surprising finds. MS is not the neuro-degenerative disease it was once thought but has a long incubation period over several decades. Some astounding results are coming out of the painfully careful epidemiology research that takes a closer look at the epigenetics and etiology. No all that has been thought about MS holds up to close scrutiny and much has some surprising results that is beginning to turn MS thinking on its head. Go to GLIMER STUDY I II and III and the crawlers will take you to IAGIM's MS drug development pages.

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    1. Neuro-Epidemiologist is presenting a 2 hour seminar/workshop in Ontario Mississauga Canada on the latest findings of the IAGIM GLIMER STUDY I, II, and III results in the first week of June 1- 4th 2015 taking place at 4850 Glen Erin Drive Mississauga L5M7SI (Seminar Building 4895 Glen Erin CH). Contact Secretary General Dr. Dori Belle, B.A., D. Pharm. of IAGIM at for full details. All are welcome as well as MS supporters and families.

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    2. Use the email info@iagim.org to contact Dori Belle and she will walk to through the details in a jiffy - Almin Goode

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    3. Both I and my husband will be attending this FIRST IN CANADA MS seminar/workshop/lecture and question time - where each attendee can submit up to three questions by email to the IAGIM Secretary General at her email info@iagim.org and they will be built into the presentation and expanded during question time - Luna and Mas Brampton Ontario
      PS this will be a evening to remember as I have heard Dr. J D Block speak in Florida - and he is absolutely enchanting and very funny as well

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    4. Thanks for contributing your comment. I've read the material on the website you suggest, and have a couple of observations. First, it's painfully obvious that whoever wrote most of the material on the website is not a native English speaker. This makes what is already difficult material even harder to comprehend due to errors in grammar and syntax. I'd urge you to find a writer with a better mastery of the English language to rewrite the website and simplify the language.

      There are also some factual errors on the website that take away from the research being presented. You state that PPMS arises out of SPMS, but I know of no evidence to that effect. In fact, it appears that these are two different entities. SPMS does arise out of RRMS, but PPMS appears to skip any relapsing remitting face. Of course, as your theory states, it could just be that the relapsing remitting state is so subtle that it is simply missed, but this doesn't explain the disparity in the male: female ratio seen in the two disease subtypes. Also, to state that MS is not a neurodegenerative disease I think is somewhat misleading. Certainly, in primary progressive MS, it appears that neurodegeneration (rather than an inflammatory process) may be at the heart of the disease. Although PPMS patients do often show signs of smoldering low-level inflammation, this does not appear to be the driving force behind their disease progression. Therefore, strategies involving desensitizing the immune system to myelin peptides will likely show little impact in the treatment of such patients. Surely, all of the treatments that have targeted the immune system have thus far been shown to be completely ineffective in the treatment of progressive MS patients. I don't see why your proposed treatment would be any different.

      I do agree that an intricate interplay between environmental agents and epigenetics is a key to understanding MS disease etiology, and that this interaction does most likely occur over the course of decades. A treatment approach that would address these environmental agents (perhaps in EBV vaccine) and/or the deactivation of activated epigenetic characteristics (perhaps HERVs) would be a very powerful course of research to pursue.

      Wishing you the best of luck moving forward with your research. It certainly is fascinating, and your very early trial results do seem promising.

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  17. Thank you SO much for this information. My husband is completely immobile, with a trach and feeding tube, and I want to try this treatment as soon as possible. I have been reading all the info possible, but am having trouble finding the difference between biotin and d-biotin. Many of the links to the various abstracts, pilot program, etc. just refer to biotin. (http://www.ncbi.nlm.nih.gov/pubmed/25787192, http://www.abstracts2view.com/aan/view.php?nu=AAN15L1_PL2.002&terms, http://www.medpagetoday.com/MeetingCoverage/AAN/51048). A general search of the web seems to have sites divided as to whether there is a difference between biotin and d-biotin.

    I contacted Pure Bulk, who is selling biotin (http://purebulk.com/biotin-pure/) and emailed regarding D-biotin - here is response: "Our Biotin is D-Biotin. There may be a difference between the two but everything I’ve found points to the fact that the only Biotin being sold is D-Biotin. I would be curious to see where you saw the statement that biotin and D-Biotin are not interchangeable. If you still have a link, please share it with us"

    I did contact a local compounding pharmacy (I am near Phila, PA) who is willing to try and source the D-biotin, and have a call into my husband's neurologist to see if he will write the prescription.

    I just want to be sure that I am purchasing a product as close to the MedDay trial one as possible. I apologize for the length of this comment and would appreciate any additional info you can provide. Thanks.

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    1. According to my naturopath, D biotin is a component of biotin. MedDay states that they use highly purified, highly bioavailable D biotin. There does seem to be some confusion over this, but according to the following link D biotin is the only type of biotin that is biologically active. See the last section of the page for this info:

      http://www.sigmaaldrich.com/life-science/cell-culture/learning-center/media-expert/biotin.html

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    2. I live in the Albany, NY area and the compound pharmacy most well-known in the area has quoted me $219 for a month's supply of pharmaceutical grade D-biotin in 100 mg capsules (incremental up to the 300 mg suggested in the study) for MS. My husband's neurologist has to fax a script to them, which should be no problem since he also did this for LDN several years ago (which did nothing for him). Please let me know if you're interested in this pharmacy.

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  18. Mark
    What do you make of people like Vicki Wilson etc with ppms who have had HSCT and seemingly slowed the progression?
    Also the release from Russia stating a 75% stopping of progression in ppms with hsct
    Also stating early disease process, young age and low edss are good factors for success?

    Also surely if the ebv theory stacks up then hsct should lower the antibodies and help?

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    1. Regarding the Russian study and anecdotal accounts of HSCT helping progressive patients, please see the reply I left about these very topics to another commentor on April 29, above. In a nutshell, I was initially very excited when I read the abstract for the Russian study, but upon reading the entire paper I was left disappointed. The paper contains troubling inconsistencies, and at times even contradicts itself. As I mentioned, you can read my more detailed comments above.

      As for EBV, not only would HSCT lower EBV antibodies, it actually largely rids the body of EBV virus load. In its dormant state, Epstein-Barr virus resides in immune system B cells, which are effectively eradicated during the HSCT chemotherapy process. Along with eradicating B cells, HSCT also eradicates and rids the body of EBV. I believe this may be one of the keys behind why HSCT is so successful. Just my opinion, certainly not the mainstream view… Remember, PPMS has a very different disease profile as far as epidemiology and patient populations go. None of the immunosuppressant drugs work on the large majority of PPMS patients, and it's likely that the neuro degeneration seen in PPMS is driven by factors other than the immune system. I do plan on writing an entire post on the latest in HSCT research, probably within the next couple of weeks.

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    2. Hi mark
      That would be great, I read on activemsers about an old Greek study into hsct for ppms that stated 3 out of 14 I know not great odds had no disease progression during the 14 year follow up!
      Also Dr Burt originally treated spms and ppms and in his study all 9 who were treated early and with less than edss 6 had disease peogression halted at 48 month follow up
      I know there are conflicting reports but I think with a chance of success and the now better quality of hsct and lower albeit still risks, it has to be an option?

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    3. I would love to talk to Dr. Burt and find out why he is now insistent on only treating RRMS patients with active lesions. Maybe I'll try to get in touch with him, it certainly couldn't hurt. Dr. Burt has written papers that explicitly state that "if no inflammation, no response". Enhancing lesions are the benchmark used to determine whether or not there is active inflammation.

      http://msj.sagepub.com/content/18/6/772.full

      So, since late stage SPMS patients and the large majority of PPMS patients don't show any evidence of enhancing lesions, I'm sure, at least according to Dr. Burt, that they wouldn't be candidates for HSCT. Of course, there are SPMS patients and even a few PPMS patients that do have enhancing activity, which would make them reasonable candidates for the therapy.

      It seems that enhancing lesions are a better benchmark than just EDSS scores when evaluating patient eligibility. Certainly, some patients who are hit very hard by the disease early on can accumulate heavy disability while still exhibiting enhancing lesions, and they would probably be great candidates for the treatment. On the other hand, a primary progressive patient who doesn't have any enhancement might have a low EDSS score but would likely be unresponsive to treatment.

      Like you say, though, since there are no other really viable treatment options for progressive stage MS, it might be worth a shot. Most treatment centers don't accept such patients, though.

      I will go over all of this in my next HSCT blog post. In the meantime, I think I will attempt to contact Dr. Burt and ask him a few questions.

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    4. Hi Marc , I follow your blog since long time . Is always a pleasure to read you.
      Looking forward to read your next HSCT blog post.
       
      I am Spanish and also PPMS ( with no activity, no enhancing lesions ) diagnosed 3,5 years ago . Three months afer my diagnose I asked my neurologist to put me on Rituximab (off label) .
      http://www.ncbi.nlm.nih.gov/pubmed/19847908

      He did it , I did 2 years ( every 6 months two 1000mg infusions). Many of my symptomes improved a lot (bladder problems , fatigue, heath sensitivity ,numbness) , but my MS was still progressing, my right side : arm , hand and leg getting weaker and weaker. So problems with walking and writting, my EDSS is now 3,5.

       
      I am also on a neuroprotective (I hope it is one , difficult to see if it s working or not) since 1 year  : amiloride.
      http://www.ncbi.nlm.nih.gov/pubmed/23365093


      I did a lot of researches and as PPMS with no approved options the choice was easy , next step : HSCT ( I am right now performing it).

      I know that HSCT is working much better in early agressive MS , and I know that the odds for progressive ( with no enhancing lesions) are worst, but I think , we PPMSers we have still inflamation . A small study  in Germany with a very powerfull MRI (Tesla 7) showed that all PPMSers had still enhancing lesion :
      http://www.msdiscovery.org/news/new_findings/11382-ppms-vs-rrms-distinction-without-difference


      There is also a postmortem study with PPMSer that shows still inflamation :
      http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2677799/


      Also for a small subset of PPMSers ,those with IgM OCB chances are even better. The presence of CSF IgM OCB may be a biomarker for a subset of PPMS patients with more active inflammatory disease, who may benefit from immune-directed treatments. 
      http://onlinelibrary.wiley.com/doi/10.1002/ana.24190/abstract


      Fassas early studies showed some benefit with progressive patients ( and the patients selection was bad ,very hight EDSS and long term disease):
      http://www.ncbi.nlm.nih.gov/pubmed/12195460

      As you statted previously ,also early Dr Burts studies showed some benefit in progressive ms , I think he is now only focussing on early RRMS with active inflamatory course because he wants HSCT to be FDA approved , if you want to win the race you need the best horses (RRMS) .
      Once HSCT got an FDA  approval  I am pretty sure they will start to focus on HSCT and Progressive MS. Same story as with DMT , since years no trials ( or very few) for progressive and now they are starting with more and more( Fingolimod ,Ocrelizumab,...).


      We have also the latest 2015 Russian study that shows also benefits for progressive MS.
      http://www.ncbi.nlm.nih.gov/pubmed/25711670


      I did my choice also with the fact that my EDSS is no so hight (3,5) , I am 40 years old and I was diagnosed only 3,5 years ago.
      I hope HSCT will stop my progression ( I am not expecting any reversal of my symptomes) and I plan to continue with a neuroprotective ( may be I will switch Amiloride with Simvastatin or even do a combination of both, I do not know yet) .
      http://www.ncbi.nlm.nih.gov/pubmed/24655729

      What are your thoughts on HSCT for PPMS followed by a neuroprotective?

      Do you think Simvastatin is more promising than Amiloride? Or may be a combination of both could work?

      Phisiotherapy and sport are also mains keys to try to stop or to slowdown the progression.

      If I am still progressing I will still try new different options , but one thing is sure : no options is not an option for us . I hope also that in  a not so far future we can all of us be on  remyelisating therapies .Great hope for MSC, but time is running out for PPMSers.

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    5. Hi, first of all let me congratulate you on being a very well-informed and researched patient. Certainly sounds like you are covering all of your bases.

      I'd love to answer all of your questions, but that would pretty much take another blog post. I'll be covering most of the issues you address in my HSCT post, which I'm hoping to get finished in the next week or 10 days.

      In short, here are my thoughts: certainly, patients with early PPMS who have OCB would stand a better chance at benefiting than long-term patients with advanced disability. As for the presence of active inflammation in PPMS patients, I'm sure that if you dig hard enough you'll find some inflammation in almost all patients with neurologic disease, but the question is whether or not that inflammation is a primary driver of their neurologic progression. From all that I've researched, I'd say that the answer to that question is no. If inflammation was a driving factor for such patients, then the powerful immunosuppressant drugs would certainly show some efficacy, and none of them have. Therefore, by extrapolation, my instincts would be that HSCT would likely not be an effective treatment. And it seems that much of the recent research backs that up.

      I am going to try to contact Dr. Burt and see if he'll answer questions about his early studies. I've come across several interviews with them, some going back a few years, in which he reiterates his stance that active inflammation as evidenced by enhancing lesions are a prerequisite for successful HSCT treatment, but I'd like to question them further.

      Anyway, wishing you the best, and you should certainly keep on doing everything you can to fight your disease. The results of several some of the state and studies have been mixed, so I would think the Amiloride might be a better option. Be careful about trying to many things at once, you never know if the synergistic effects might actually be negative.

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    6. Also, in looking over the German study of lesions in PPMS and RRMS patients, I'd note that they were looking at the structure of the lesions, not whether or not they were at one point enhancing lesions. There is some controversy over whether or not there are structural differences in MS lesions from patient to patient, or even in different lesions within the same patient. This is a different question than that of enhancement, though. The presence of enhancing lesions is a strong indicator of immune activity driving the disease forward in patients, whilst its absence would seem to indicate that there are other culprits at work. I don't think the story here is strictly black or white, there is certainly room for gray areas, but as a patient who has never had enhancing lesions, has tried a wide variety of immunosuppressant drugs (including Rituxan), and never seen any positive effect, only ever increasing disability, I can say from a personal perspective that I don't think my disease is being driven primarily by my immune system… Still, if HSCT was locally available at a reasonable cost I might just give it a shot, strictly on a "what the heck" basis. Nothing to lose in that scenario, really, other than my hair and the wear and tear of the chemotherapy, which at this point might just kill me… (Only joking there, don't want to scare anybody)…

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    7. Hi Mark, thanks for,your answers . I am looking forward to read your next HSCT post .
      It would be interesting if you can also contact Dr Fedorenko in Moscow (related to the latest 2015 Russian study that shows also benefits for progressive MS.
      http://www.ncbi.nlm.nih.gov/pubmed/25711670
      He believes strongly HSCT can stop further progression in MS.
      If you need his email or tl number please let me know.

      A last question , for a Spanish close friend , she is RRMS ( active lesions , enhancing lesions per gadolinium RMI), more than 3 DMD failed ( she was doing very well with Tysabry but tested JVC +) , 33 years old and diagnosed since she is 18 , but still low EDSS ( 1,5) : she wants to perform HSCT ( myelo) in order to avoid further progression to SPMS , his neuro wants to put her on Alemtuzumab , I think in her case I will favoured HSCT .
      What are your thoughts on Alemtuzumab versus HSCT (BEAM protocol) and Alemtuzumab versus non myelo HSCT ?
      Thanks in advance.
      Juan.

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    8. Hi Juan, as I mentioned in a previous comment, I was very disappointed in the recent research paper put out by Dr. Fedorenko. Though the results looked very promising, but upon reading the entire paper I found it filled with inconsistencies and lacking vital info (such as patient histories). For me, at least, lots of red flags raised. Was really hoping to find some solid data, but, like I said, wound up very disappointed.

      As for your friend, since I'm not a medical professional, I really am not in a position to give recommendations for anybody but myself. Personally, in that situation I would probably go for non-myelo HSCT, but that's just me. Lemtrada is certainly a viable treatment option, especially since it is approved for MS and therefore covered under many national medical programs. It's efficacy is only slightly less than HSCT, but long-term side effects seem a bit more troublesome. I certainly wouldn't advise against Lemtrada in general, though, but patients need to carefully discuss potential side effects with their Dr.

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  19. Marc, this is great information, and thanks so much! I've been reading about the Biotin trials, but this is by far the most informative I've seen.

    One thing you said in your original post has me puzzled:

    "MedDay’s Biotin compound should be ready for FDA approval by the end of this year."

    I don't claim to know much about the FDA process for approval, but this can't mean approval as in given the OK for market, right? Does this mean "ready" as in trials will start this year in the US that will take several more years, and then after that, the FDA will decide if they will approve it?

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    1. Hi, the trials that MedDay just finished were phase 3 trials, the final stages of the trial process. Nothing is guaranteed, oOf course, but my understanding is that the company will file for FDA approval based on these results by the end of 2015. I wouldn't be surprised if one of the larger pharmaceutical companies bought MedDay before then, as their compound, if approved, would be the only approved therapy for PPMS on the market. As MedDay is currently a privately held company, they would need to greatly expand their financial resources to properly bring the pill to market. I imagine some of the players already in the MS field (Biogen, Novartis, Teva, etc.) would be quite interested in making such an acquisition…

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  20. Thank you for clearing that up, Marc. I have not seen this piece of it anywhere else, and I get the impression that this is not common knowledge, even among a lot of people who are aware of the Biotin developments.

    Sometimes hope can be cruel, but for me, it's the only reason to keep going on from one day to the next.

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    1. Just did some further research, and MedDay is conducting a second phase 3 trial on patients with permanent vision loss due to optic neuritis, which should be completed in the second half of 2015. If that trial proves successful, I would expect that MedDay would submit their NDA (New Drug Approval) to the FDA soon after. So, maybe approval by the end of 2015 is a little optimistic. Maybe more like first half of 2016. If a bigger pharmaceutical company gets involved it couldn't help speed the process along. In any event, we are probably looking at approval somewhere within the range of 8-18 months…

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  21. Hello! Have you found a compounding pharmacy that could create pharmaceutical grade D biotin capsules?

    Thank you for all your research and delivering it in a practical and intelligent way. There is so much misinformation regarding MS. I appreciate finding a voice of reason out there.

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  22. Mark
    Not sure if you know but knowing you I'd say you do lol
    There's some trials going on with vitamins that have shown benefit, one being n-acetylcysteine and the other alpha lipoic acid?
    Not sure what ypu think, but I've read a lot about NAC being used to treat ocd which is believed to be a by product of a virus attacking the brain? Could be good?
    And both that and lipoic acid have been used to treat Alzheimer's and other degenerative diseases

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  23. Congratulations on your award!! It is well deserved. I know I can always count on finding the latest, thoroughly researched MS information on your blog. I'm sorry you have a reason to write this blog but I am so grateful you did. Like most of the online MS community, we'd be lost without you, wading through medical articles trying to make sense of words like oligodendrocytes and neural progenitor cells, until you come out with an easily accessible version of the same information. And then we're like "aha!" now I think I get it. Or get it as much as an MS brain can get it. Even if we can't stop what it going on in our bodies, it's at least nice to 'know our enemy'. Your depiction looks pretty scary. I'm off to search for more articles on the 'new' discovery of lymphatic networks in the brain and look forward to seeing if it is worthy enough to make an appearance on your blog, or just hype, as so many discoveries turn out to be. Hope you are well as can be.

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  24. has anyone heard of a device called PoNs? its a device that rests on the tongue and You do exercises both mental and physical while it sends electrical impulses through the tongue; its supposed to reverse all TBI's; its in clinical trials....

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    1. I recall seeing something about it last year. Is it being tested at the University of Wisconsin? I think Montel Williams was somehow involved…

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    2. Yes, Montel is involved, and got the U.S. Army involved in funding as it has the ability to help all TBI's no matter what the cause, bomb blasts, car wrecks, MS, Parkinson's, any cause of TBI's it is in clinical trials in Wisconsin....

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  25. Today in Press Releases of biotin producers:

    MedDay, a biotechnology company focused on the treatment of nervous system disorders, and DSM Nutritional Products, global leader in innovative nutritional solutions for the pharmaceutical, food, feed and cosmetics industries, today announced a partnership and co-investment for the manufacturing of pharmaceutical grade D-Biotin.

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  26. It will be very interesting to see how all this develops, MedDay seems to be preparing for a Launch.Big pharma might be interested.Hope and pray that it does not leave us in a Limbo! Great site AND THANK YOU.

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  27. Thank you for all the time you spend on research and writing this blog. It has helped me tremendously. I was wondering if you did start on Biotin? I was able to get Biotin in pure powder form and have been givong it to my brother. It has been almost two months but unfortunately have not yet seen any improvements, however, we are still optimistic and have faith. I believe it will take a few months to start seeing any kind of slight improvements. Thank you for sharing your knowledge and experiences.

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  28. Thank you for all the time you spend on research and writing this blog. It has helped me tremendously. I was wondering if you did start on Biotin? I was able to get Biotin in pure powder form and have been givong it to my brother. It has been almost two months but unfortunately have not yet seen any improvements, however, we are still optimistic and have faith. I believe it will take a few months to start seeing any kind of slight improvements. Thank you for sharing your knowledge and experiences.

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  29. Marc!
    What do you think about it?
    http://multiplesupplements.com/products/ms-biotincomplex

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    1. Sorry, but I kind of think this is a rip off. First of all, it only has 75 mg of biotin, and the dose required according to the study was 300 mg. Also, I'm not sure what grade biotin they're using in this concoction. And, lastly, I have very little trust these days in what's actually in the Supplements you can buy over-the-counter. Lots of scandals involving this lately, with findings that the majority of OTC supplements don't contain much of what they say they contain on the outside of the bottle.

      I would recommend trying to get a prescription for pharmaceutical grade biotin, procured from a compounding pharmacy. My understanding is that Skips Pharmacy in Boca Raton Florida is supplying many patients. Also, don't go into it expecting any miracles. Remember, only 12% of patients taking the stuff during the phase 3 trials saw improvements. Of course, that's much better than the 0% taking placebo, but do try to keep things in perspective.

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    2. I think too.
      My sister has MS (almost 26), she was diagnosed in 2013., (use Tecfidera) and now after only 2 clinical flare, her sympthoms maybe gradually worsening. The last 2 attacks (mild swallowing problems, and INO with nytagmus appears and gradually worsening, (do not reach, her flares sympthoms), and she experienced dizzines too.

      So after all, if would be a miracle, if her current state remain, and most of the 'biotiners' remain stable, but most of the placebousers too. I don't know.

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  30. This is pharmaceutical grade biotin....
    http://www.sigmaaldrich.com/catalog/substance/biotin244315885511?lang=hu&region=HU

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  31. Hi Marc,

    Have you heard anything about the commercial availability yet? Thanks!

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    1. No, I haven't heard anything about commercial availability yet. I would guess they'll go for FDA approval sometime during the first quarter of 2016, and then it will be several months to get the product out. In the meantime, you can try the compounding pharmacy route, if you just can't wait…

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    2. Oh, and I'm guessing that you were talking about biotin. Dr. Sadiq's stem cell trial just got an approval to go ahead with phase 2, from the FDA. So, it will at least be several years before any kind of commercialization of the stem cell process that Dr. Sadiq is testing is possible…

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  32. Very promising information. How does this compare to HSCT in Mexico?

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    1. Comparing this type of stem cell therapy (regenerative stem cell therapy) to HSCT is comparing apples to oranges. Regenerative stem cell therapy aims to repair the damage done to the nervous system by Multiple Sclerosis, whereas HSCT attempts to halt the disease process by rebooting the immune system. Completely different approaches. As a matter of fact, in theory, at least, patients could undergo HSCT to put a halt to their disease process (keeping in mind that HSCT works best on patients with active relapsing remitting disease) and then undergo a regenerative stem cell regimen to try to repair the damage that had already been done. Please keep in mind that regenerative stem cell therapy for MS is still in the experimental stages, there is still much work to be done…

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