Stem Cells Versus DMTs: MS Treatments Go Head to Head

Stem Cells Versus DMTs: MS Treatments Go Head to Head
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People with multiple sclerosis have been waiting for this: A full-scale clinical trial testing the effectiveness of stem cell transplantation as an MS treatment. The trial is being conducted by the U.S. National Institutes of Health, and it’s enrolling people with MS at several centers in the United States and one in the United Kingdom.

The U.S. has been behind the curve when it comes to approving stem cell treatments for people with MS. Autologous hematopoietic stem cell transplantation (aHSCT) has been available in Mexico and Russia for several years, but isn’t widely available in the U.S.

In the procedure, doctors collect a patient’s blood-forming stem cells, give the patient high-dose chemotherapy to deplete the immune system, and then return the patient’s own stem cells to rebuild the immune system. The system, hopefully, returns free of cells believed to be involved with MS.

Three years ago, following a promising aHSCT study, Dr. Anthony Fauci was optimistic but cautious. Fauci is the director of the National Institute of Allergy and Infectious Diseases. He said, “These extended findings suggest that one-time treatment with HDIT/HCT may be substantially more effective than long-term treatment with the best available medications for people with a certain type of MS.” But Fauci emphasized that a larger trial was still necessary. It appears that trial has finally arrived.

BEAT-MS is enrolling participants

The Phase 3 trial, called BEAT-MS (NCT04047628), will put aHSCT head-to-head against the top-line disease-modifying therapies (DMTs) available in the U.S. to treat MS.

It will enroll 156 adults, ages 18 to 55, with a diagnosis of relapsing-remitting MS (RRMS) at 21 sites — 20 in the U.S. and one in the U.K. Participants will be randomly assigned to receive either aHSCT or one of the high-efficacy MS treatments currently in use: Ocrevus (ocrelizumab), Lemtrada/Campath (alemtuzumab), Tysabri (natalizumab), or Rituxan (rituximab). The participants, who won’t know which treatment they’re receiving, will be followed for six years.

In a news release, investigators said they want to compare how much time elapses between the start of the treatment and an MS relapse. They’ll also compare the newly developing immune systems of the participants who receive aHSCT with the immune systems of those who receive a DMT.

Finally, they’ll compare the effects of the two treatment types on other measures of disease activity and severity, their cost-effectiveness in terms of healthcare costs and productivity, and participants’ quality of life. “We hope that BEAT-MS will clarify the best way to treat people with relapsing MS,” said Dr. Jeffrey Cohen, the trial’s leader.

Let’s get moving

I hope so, too. A study such as this is long overdue. But I think I echo the feelings of many people with MS when I express dismay that we’re probably still at least six years away from approval of aHSCT in the U.S.

As I wrote three years ago, “[S]cientists have been studying stem cell treatments for years and it sure seems as if we’re still crawling when we should be cruising.” Also, why limit this study to people with RRMS? Why not include those with primary and secondary progressive MS? Am I wrong to think that they would benefit from aHSCT as much, if not more, as those with relapsing MS?

What do you think?

One more thing

Starting this month, Multiple Sclerosis News Today columnist Jennifer Powell and I have begun recording MS news and feature stories in audio format. Jennifer’s audio reports are available on SoundCloud every Monday, and mine are available every Thursday. Click here to give us a listen.

You’re invited to visit my personal blog at www.themswire.com.

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Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to multiple sclerosis.

Diagnosed with MS at age 32 in 1980, Ed has written the “MS Wire” column for Multiple Sclerosis News Today since August 2016. He presents timely information on MS, blended with personal experiences. Before retiring from full-time work in 2012, Tobias spent more than four decades in broadcast and on-line newsrooms as a manager, reporter, and radio news anchor. He’s won several national broadcast awards. As an MS patient communicator, Ed consults with healthcare and social media companies. He’s the author of “We’re Not Drunk, We Have MS: A tool kit for people living with multiple sclerosis.” Ed and his wife split time between the Washington, D.C. suburbs and Florida’s Gulf Coast.
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Diagnosed with MS at age 32 in 1980, Ed has written the “MS Wire” column for Multiple Sclerosis News Today since August 2016. He presents timely information on MS, blended with personal experiences. Before retiring from full-time work in 2012, Tobias spent more than four decades in broadcast and on-line newsrooms as a manager, reporter, and radio news anchor. He’s won several national broadcast awards. As an MS patient communicator, Ed consults with healthcare and social media companies. He’s the author of “We’re Not Drunk, We Have MS: A tool kit for people living with multiple sclerosis.” Ed and his wife split time between the Washington, D.C. suburbs and Florida’s Gulf Coast.

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35 comments

  1. NS says:

    Thank You Ed,
    I 100% agree with you. I don’t see how people with Secondary and Primary would not benefit by being included in the trial. I know that it is more difficult to monitor their MS progression, but I feel strongly that they have been neglected for too long and should not be left out. There must be some way of including them too.
    NS

  2. Lorraine says:

    We have waited long enough, why is the FDA so slow in approving stem cells for MS
    when other countries are doing stem cell transplants, it is cruel!!

  3. Jeff says:

    Yes Ed, I was a bit saddened to be eliminated from this, but then again at this point I doubt that much of my damage will be reversed.

    This is a very dangerous procedure, killing the immune system; but I would still sign up in a heartbeat! From what I understand when this has been done in other countries the long term success rate has not been all that high; but a six year test span is still very conservative. Still, they are learning all the time. Perhaps if results show significant improvement at, say, three years they may approve it sooner.

    A concentrated effort in the US would be very interesting. If it proves successful I wonder how negativity it would effect all the drug companies? They would sure hate to loose their cash cows. Would they stop developing new drugs? Something to think about.

  4. Rhonda Danielson says:

    Ed and NS,

    Thank you, both of you for thinking about the rest of the MS community. Any form of MS is ugly, but as someone with PPMS and “older” -over 55, I feel like the proverbial red headed stepchild-left out of everything.

    Wouldn’t it be great if we could “grow out” of MS by simply getting older?

    Six years is a lifetime. Why not data mine the records of the folks that have already done this? That information could shorten the six year follow up.

    Regardless, Ed, thank you for the article. This is great news.

  5. Michael says:

    Hi Ed, I agree this is long overdue, I’m 58 years old and SPMS. The only options I have to try and halt my MS progression is an overseas visit to Moscow or Mexico. This is my only hope. This study will benefit those earlier in the MS journey and I hope it proves to the industry that this is indeed a credible treatment it will have a huge impact on people’s lives.

  6. Myeshi says:

    Ed,
    Thank you for this article. I am currently in Puebla Mexico receiving treatment at Clinic Ruiz and initially it wasn’t an easy decision. 17 years with this MonSter and have tried many DMTs, when I was ready to submit application for Dr. Burt’s clinical trial at Northwestern University he had decided to go on sabbatical to teach and speak about HSCT treatment for Autoimmune diseases. My neurologist offered 3 options, as he felt I was no longer RRMS but SPMS, tysabri (already failed), ocrevus, or lemtrada. I researched and pursued HSCT in Puebla and wrapping up my 2nd week I can’t say enough about the treatment. Harvested 1.2 billion stem cells yesterday!! Last day of chemo is today and will receive my stem cell transplant tomorrow. Came here knowing this is not set up for repair my goal was to stop progression. I’m no medical expert just living with this everyday and trying to hang around as an active participant as I can be for my hubby and 9 yr old daughter and almost 7yr old son. I live in the DMV area and will be happy to keep you posted on the rollercoaster I will be facing returning home as an immunocompromised person for the next couple years. I know the treatment is only the beginning and am getting my hematologist lined up to follow me when I return home Feb 2nd. Thanks again

    • Ed Tobias says:

      Hi Myeshi,

      Thanks, so much, for sharing your information.

      Yes, please keep us all posted on your aHSCT rollercoaster. I’m sure everyone reading this is anxious to hear about your experience and hoping that you will do well. If you contact me directly at [email protected] I’ll can write a column or two about your treatment.

      Best of luck,

      Ed

      • Melanie Rice says:

        Ed,
        It’s a shame that so many of us are having to fundraise for this life saving procedure. It should be made available to everyone suffering from this dreadful disease. How many more clinical trials are they going to do? BEAT MS is ridiculous. Haven’t they done this clinical trial already anyway? 🤔 They already know what the results are for people who are on DMD’s and they already have information on aHSCT, so now, why are they comparing the two and dragging the clinical trials out even longer? If it were them, their mother, father, sister, brother or child, they would choose aHSCT, guaranteed! I am currently going through fundraising HELL trying to have the treatment in Mexico. I can’t get there soon enough, as time is not on the side of someone with MS. I feel absolutely desperate to have aHSCT done! The despair that people with MS have is heartbreaking! Some even have suicide plans for when the time comes that it is too unbearable. That is such a scary thought and so sad, but what’s even more alarming is that I get it! I never thought I would, but I do now. I would be happy for you and anyone else to watch my journey, once I fundraise the money. GoFundMe is slow going, unfortunately. So off to raffling and auctions I go. Something else I have found with this disease is that your friends are few and far between and aren’t as eager to donate to your cause as you think, even when you resort to begging. Once I go, please feel free to follow me on my way to a new me, no hair and all! ☺️🧡🧡🧡🧡
        Melanie Rice
        stop my MS with HSCT!

    • Karen Jackson says:

      Myeshi
      I know another person in the DMV area that had aHSCT at Ruiz almost 2 years ago. Connect with me directly if you want f/up
      The person doing well again no cure but trying to slow progression.

    • Tisha says:

      I would love to hear about your journey with HSCT. I’m just now trying to start the journey of going. I so hope that it is worth it. Would love to hear how you are doing.

    • Tara Thomas says:

      Please give an update to your treatment, i pray all is well with you especially now with the pandemic. Anyway thank you for your journey!!!

  7. Claire says:

    As usual NOT available for people with PPMS! Don’t these people realise that this treatment can work for PPMS suffers, some of who are currently being offered NO treatment options in the UK? When is someone going to stand up and fight for these people who are not being helped at all and for whom time is against?!

  8. Helene m Patterson says:

    I had stem cell therapy in Chicago about 4 years ago. I believe that they would help MS people extremely. I had two treatments in two years. They did not give me chemo therapy. They took my fat cells from my stomach and turned them into stem cells and injected them into my spinal cord. The first treatment really helped me. My walking got better to the point I could walk with a cane not a walker. My fatigue improved. I use to get out of bed in the am and could hardly walk to the kitchen without fatigue. After stem cells that improved. My second treatment helped also. I feel like it still is helping and my last treatment was 2 years ago. Then the government stopped DR’s from doing this. It is so sad that the government can stop things that are helping people. I wish I knew how to start a protest so that people can benefit from modern science. SO SAD!

    • Ed Tobias says:

      Helene,

      I’m glad you’re doing well but I do need to point out that the stem cell treatment you had is not the stem cell therapy (aHSCT) that this test involves. aHSCT removes actual stem cells from a patent’s bone marrow.

      Ed

  9. Helene m Patterson says:

    One other thing, we say the drug companies will try to sabotage this treatment because of sales of DMT. But, this therapy does not cure MS just hopefully lessens our disabilities, we will still medication to keep it from progressing.

  10. Paul Hatch says:

    Hi Ed,
    Another great article, thank you.
    I have PPMS and feel as most of us with SPMS & PPMS, left out of something that (as you mention in you column) would also be beneficial for SPMS & PPMS.
    Certainly hoping that sometime soon there will be a trial conducted using aHSCT for us with SPMS & PPMS.
    Thanks again Ed!
    Regards,

    • If you are looking to do the HSCT TREATMENT outside the USA, you can get treatment, but it is not based on your Type of MS. It is based on your EDS Score. Your Neurologist should have that in you file.

  11. John says:

    Good thing they do this trial, but it will take many years before we see conclusions, followed by many years before its common practice. For aggressive RRMS, aHSCT is so effective (stops RRMS in around 80% of cases), this should be available for each patient with aggressive RRMS where 1 or 2 second line DMT’s have failed!
    “The participants, who won’t know which treatment they’re receiving, will be followed for six years”. I’ve seen my daughter have both DMT treatment and later aHSCT, I am 100% sure every patient will know the difference between the two as soon as treatment starts.
    aHSCT is a great treatment for very aggressive RRMS, my daughter and many others I know have MS stopped and even experience improvements (because it stops the active leasions, NOT because of damage/myelin repair, that is not possible yet)

  12. It does zero good to remove a MS patient’s own stem cells and then put them back in, stem cells need to be from another source, clean, new, non-diseased if really want to see stem cells work and only reason US is lagging is the big Pharma control over FDA

    • Ed Tobias says:

      I would disagree with you, Larry. The stem cells aren’t diseased. It’s the immune cells in the blood (T and B cells) that are the bad guys, not the stem cells. The adult stem cells that are harvested from a patient’s bone marrow are “pre-programmed” to generate new immune cells that, hopefully, won’t carry the rogue “hitchhikers” that cause MS when they’re returned to the body.

      Here’s a good description from the UK MS Association’s website:

      “The aim of AHSCT is to replace or reboot your body’s immune system so that it no longer attacks your myelin or causes inflammation in your brain and spinal cord. AHSCT uses high doses of chemotherapy to wipe out your existing immune system, which is then rebuilt using stem cells collected from your blood before you have the chemotherapy. The hope is that your rebooted immune system will stop attacking you and there will be no further damage.

      Using your own stem cells minimises the risk of them being rejected by your body. If the stem cells come from someone else (a donor) it’s known as an allogeneic transplant – this is associated with a higher risk of complications than an autologous (self) transplant, so it’s not generally used for MS.”

      Ed

  13. anon says:

    Good to see this news. Have always been very sorry that neuros continue to prescribe injectables as first-line treatments. Not blaming the doctors, of course, but drug companies should not be allowed to push products that should in general be pulled. Maybe we can go back to steam engines, too, and the Pony Express.

  14. Alim Jessa says:

    This is definitely long overdue, I was diagnosed with aggressive RRMS in 2015. I chose not to go on any of the nasty drugs and did HSCT in Moscow, Russia in October 2015. My edss improved one full point to a 3 and I have not seen any progression till date. I have done 4 mri’s since transplant. If I was in the same position again, I would do the same thing I did.

  15. Jan says:

    Thanks for posting the news about ms Ed . But i am very curious about dr Su Metcalfe her findings.Could you are anyone give a update ? Excuse my bad englisch 🙂

  16. Scott macewan says:

    Hi Ed
    I am in Monterray Mexico right now for hsct. Some original trials were done ic Canada in the 1990s in Ottawa and were successful. All the protocols used at the 23 places doing it are much less harsh , and successful in all types to some extent. They take the cells from your blood, and do not haveto freeze them due to their timelines. They do extensive pretesting and consultation. Its is done on outpatient basis with accomodation and transport. It is a way to stop progression , recovery is a bonus.

  17. MS doesn’t choose by age or how severe the disability!! This study is going to be so skewed by not involving an open door at some of the Hospitals!! The Clinics that have been doing this Treatment and have it down to a Science, with all that goes along with it, did anyone think about looking at their operation, statistics, Rate of Success? One of the Clinics is run by One of the Top 5 Doctors in the World in last years Medical Journal 2019. He has studied Hematology and has taught Hematology at some of the top Hospitals in the USA, even though he is From outside the USA, but what a wonderful clinic He Runs with a Wonderful Team of Doctors, Nurses, All the Other Specialty People Needed. He even Has a State of the art facility For Patients and their caregivers two stay in right close to The Clinic and Drivers to take you to all your appointments. They have a full service cafeteria open all day and Cleaning service to each persons individual room. If you ever go to their Website or have the pleasurer of reading what patients write or even say if you are Lucky enough to talk to one, is the feeling of sadness of leaving behind a Top Notch Medical Clinic, Staff From Top clear to the Drivers and Cleaning staff. So I have signed up months ago, don’t know it I will have to change my month, but that won’t stop me. I have had RRMS for 20 years. It has only of late caused me many different problems, the Main One Walking with a Walker for the last 8 months. And Over the Years I have been on All The A B C Drugs and dealt with shots. Then put on Gilenya a pill Finally, no more shots!!!!! But none of the DMD”s have really work. I’m going off Gilenya, which we were not told about any of the scary side effects when we went on the wonder drug of the moment. Have to be off your DMD For 3 Months before Treatment. I’m Praying for the Best!

  18. Barry says:

    My 30 y/o son just got the MS diagnosis. His professional life was just beginning to take off and to be married this fall.
    Makes me sick to see Fauchi and company (who have flip flopped on so many fronts with this covid-19 pandemic) tell us to wait for another drawn out study while lives are destroyed, all the while there is years of data on previous procedures available in the literature. President Trump really needs to be lobbied in a big way to get this procedure (aHSCT) into his ‘Right to Try’ legislation because the detached and egotistical bureaucrats will only change their ways when it effects them personally.

  19. Richard says:

    After seeing this it was exciting but a little sad on my behalf. I have progressive MS and would love to see the outcome from similar persons. But still hopeful that something will come. I want to be able to walk again. Also saw have a cbd in the study and I think clincal, that they found it can repair the myelin in the spine. With that being said I have talk to a guy that was bed ridden and only given a year to live. He started using cbd and marijuana, now he’s walking so I believe there is benefit with that and believes those are the reason for his comeback. Either way I have great hope that one day I will be back on my feet.

  20. Kim Vanderford says:

    I went with my sister in Jan 2016 to Mexico for her HSCT.
    She has had RRMS since 1995. Every year when she had her MRI she had developed new lesions and had 2-3 relapsed during the year. She had been on several different drug treatments. Since her HSCTshe has had no new lesions and no relapses. The damage done by lesions is irreversible, BUT no new damage. At first, alot of people note improvement and for some it stays but for some their mobility and other symptoms stay the same. Mexico was a highly professional and very attune to your every need. We regret we didn’t do this several years earlier and encourage people not to listen to their neurologist about the negativity of going to Mexico. They use chemotherapy which is a must for the treatment to work. Your hair falls out and maybe a couple of days you don’t feel great but not as bad as imagination makes it out. 28 days and you go home and leave MS in Mexico! PS. There is alot of $ involved in drug treatment and drug companies and some doctors reap the benefits. Plus alot of doctors won’t do the research as to why this works!

  21. Mohammed Tariq Bayrakdar says:

    This disease should be coming from some place if we could built a live map of present and active people ms may be we could locate the generation and development of this disease.

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