Stem Cell Treatment Benefits Three-fourths of MS Patients in Phase 1 Trial

Stem Cell Treatment Benefits Three-fourths of MS Patients in Phase 1 Trial

A stem cell treatment improved the neurological symptoms of three-fourths of the multiple sclerosis patients in a Phase 1 clinical trial, New York researchers reported.

The results prompted the team at the Tisch MS Research Center of New York to start a Phase 2 trial to further assess the therapy’s safety and effectiveness.

Injecting mesenchymal stem cell-derived nerve cell progenitors directly into the spinal canal also improved the muscle strength and bladder function of many of the 20 progressive MS patients.

The study, “Phase I Trial of Intrathecal Mesenchymal Stem Cell-Derived Neural Progenitors in Progressive Multiple Sclerosis,” was published in the journal EBioMedicine.

Eighty percent, or 16, of the patients in the open-label trial (NCT01933802) had secondary progressive MS.

Half were unable to walk at the beginning of the study, and had EDSS disability scores of 7 or higher. Eight required assistance to walk, and had EDSS scores of 6 to 6.5. Two were able to walk without assistance, with EDSS scores between 3.5 and 5.5. EDSS stands for Expanded Disability Status Scale.

The stem cell treatment led to improvements in 15 of the 20 patients’ neurological symptoms. The disease of two worsened, and the condition of three remained the same.

Fourteen of the patients had better muscle strength after the treatment, mainly in the lower limbs. Four of the 10 patients who were able to walk when the trial began improved their scores on a measure of exercise capacity — the timed 25-foot walk test — by 20 percent or more. And two patients who had been unable to walk when the study began were able to complete the walk test with assistive devices.

Patients who responded to the treatment improved their disability scores by 0.5 to 2.0 EDSS points

The stem cell treatment improved the bladder function of half the patients with a problem. Some were able to stop taking their bladder medications.

There were no serious adverse effects associated with the therapy. About 85 percent of the patients experienced headaches and fever in the first 24 hours after the treatment, which doctors managed with standard medications.

The treatment consisted of three injections of stem cells derived from the patients, administered three months apart. Patients received antibiotics to reduce the risk of infection.

Researchers used fresh cells rather than cells preserved by refrigeration. This may have contributed to the good results, they said.

“The protocol we created allowed for delivery of these stem cells within 30 minutes of harvesting” them, Dr. Violaine Harris, a senior research scientist at the Tisch center, said in a news release.

The Phase 1 results “justify the initiation of a planned FDA-approved Phase 2 trial in a larger group of patients,” said Dr. Saud A. Sadiq, the Tisch center’s director and senior author of the study.

“We anticipate that these novel studies may form the therapeutic basis of reversing disability in patients with MS, and if successful, these studies could have positive implications for treating other neurological diseases,” Sadiq added.

The Phase 2 trial (NCT03355365) is recruiting about 50 patients with primary progressive or secondary progressive MS. Patients must have an EDSS between 3 and 6.5. For additional information, visit the trial registry webpage.

31 comments

  1. Heracles says:

    Talk about a slow boat going around Tierra de Fuego instead of through the Panama Canal. Stem cells should have been the focus years ago!!! Think of all the people that would not have had to suffer from this horrible disease. Instead, we have gotten ineffective toxic medicines that cause cancer, PML, organ failure, skin necrosis, and death. Big Pharma doesn’t care; they want stem cells to go away or be used as the last line of treatment after they have gotten every last dime from the patient.

    • GM says:

      This clinical trial by the researchers (led by Saud Sadiq, MD, FACN) at the Tisch MS Research Center is a proof-of-concept scientifically-controlled clinical trial that involves intervention. Phase I was overall positive and overall safe…..it’s important to PROVE efficacy and safety for these interventions so that down-the-road, maybe this MS treatment methodology will PROVE to be superior to the current $XX,XXX/year Biologicals from BIG PHARMA…..and shut down their usage! The Tisch MS Research Center had to fund their own research to prove this and it’s ridiculously expensive! BRAVO & Blessings to Saud Sadiq, MD, FACN and his research teams!

      • Heracles says:

        GM, The stem cell procedure has been around for over a decade. I understand that Dr. Sadiq is not utilizing chemo. Dr. Burt at Northwestern Memorial Hospital in Chicago has been using chemo and stem cells successfully for years. Over 2000 patients worldwide have been treated with stem cells with a 70%-80% success rate. Americans should have been given this choice a long time ago but the FDA is protecting Big Pharma profits.

        • Jeff Persi says:

          Heracles, I was set to fly from CA to IL to start treatment with Dr. Burt (mid 2017), all expenses out of pocket, and shortly before my appointment was canceled/denied due to my diagnosis of PPMS. Dr. Burt will only treat patients with Relapsing forms of MS…so this is extremely exciting news led by Dr. Sadiq.

      • Dr. Saud Sadiq is my neurologist and I am so grateful that he and his research team think out- of -the- box with innovative methods improving conditions for primary and secondary progressive ms patients.

        • Heracles says:

          Diane, please tell your story so that Americans can realize that they are being given toxic snake-oil while the real cure for MS, stem cells, get put under the rug or called “risky” in every news story about it.

      • Richard Peterson says:

        I am grateful that people do in fact exist possessing the courage to resolve MS instead of simply capitalizing on the misfortune of others like me with MS who suffer every minute of every day. Meanwhile I’ll keep saving money to fund my own salvation <3

  2. Jill says:

    This is really a no brainer! I had HSCT with chemo in Russia 7 months ago and it has changed my life! Shame on the medical world for not allowing this sooner.

    • Daryl says:

      Tell us more about HSCT what treatment is that I have looked into going to Mexico and other places for stem cell, I would like to look at having something done before I can not do anything for myself as it stands now I use a walker but falling all the time is crazy.

    • Heracles says:

      Jill, PLEASE tell people your story. Another data-point that shows that the FDA cares more about Big Pharma profits than sick Americans.

  3. Pam Brirr says:

    My son had a stem cell transplant at Northwestern in Chicago in 2009 and it was a miracle! No more active lesions! Now we are looking for Melyn regeneration to resolve a couple of lingering issues.

    • Heracles says:

      Pam, please tell people your son’s story. There is no reason that people should continue to suffer and be forced to take toxic ineffective meds just because the FDA wants protect Big Pharma.

  4. Heracles says:

    The next time that you join a walk for MS, ask the leaders if they are willing to raise the money to get people stem cell procedures!!

    I hope that people understand that MS is a huge moneymaker for all those involved. A disease that slowly sucks the life out of young people as they age. People desperate to slow the disease pay tons of money and suffer horribly. Big Pharma, national MS organizations, neurologists, hospitals, sales reps, and others are all on the take. The worse thing in the world for them would be a cure.

    • Donna says:

      When the MS society changed their motto from “finding a cure” to “living well with MS”, I realized that they are a huge part of the problem instead of the solution. They have given ZERO dollars to this trial and ZERO dollars to the 15+ year trial in Chicago. PLEASE stop supporting them and instead donate to Tisch. The NMSS is a multi million dollar business that only funds big pharma, and in turn, big pharma gives them millions to advertise their poisonous drugs in their magazine.

      • Laura says:

        A few years ago, I asked my local MS society for help purchasing an electronic device. The max amount they could give wad $500. I filling out the application and they wanted to know how much money I could get from my family and friends. I flipped out! Since my diagnosis in 1998 and my daughter’s in 2011, my family and friends have been donating to the society! No more! What a racket they,as well as many others have going! It’s so sad and maddening…..

      • Myles Winston says:

        It’s good to see that everyone understands that it’s “Big Pharma..$$$” that is keeping us from becoming well.

        They only care about profits and damn the patients.

        I am completely disabled with PPMS but refuse to enrich their coffers by taking their useless drugs…

    • Amy says:

      So agree Heracles !
      I will trust the MS Society when I hear about other solutions besides the gambling casino of drugs and the doctors telling you to try one till
      till that isn’t working and than another (plus all those horrible painful side effects!

  5. Kevin Keplinger says:

    What’s happening in the MS community with HSCT is an outrage!!!! HSCT should’ve been recognized as a frontline treatment years ago, yet no one, especially the NMSS will even mention it!! Most MS patients have never even heard of HSCT. Outrageous!!!! There is currently a mass exodus of MS patients leaving the country to get treatment!! Treatment that actually works, not drugs that “help you manage you disease”!!! Where is the NMSS??!! Out going on a bike ride or taking a walk I guess!!!!

    • R. Picone says:

      Agreed
      Year and half ago , after 10 years of different tests I got the news….
      Now on the DMD treadmill.
      HSCT is the ONLY way forward!!!
      Fully agree with your comments, as my experience with some medicos has been horrendous……
      Just wish I could afford it …

  6. Susan Moreau says:

    I am gathering info on the treatments in Russia and Mexico. While they seem similar, does anyone know the differences? Has Russia been doing it longer? Susan

  7. Merblair says:

    Dr. Burt only wants patients he can help. I was rejected from his trial, I suspect i was too old. I have been in touch with one of patients a mom of two. She did well so far, I think. His is a difficult process, and my last neurologist said he wouldn’t do HSCT unless he was dying!!! as far as lemtrada, he said side effects were manageable YIKES.
    I am on Ocrevus.

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