Promising Phase 1 Trial Results of Stem Cell Therapy in Progressive MS Patients Being Presented at AAN Meeting

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progressive MS clinical trial

Potentially groundbreaking research by the Tisch Multiple Sclerosis Research Center of New York (MSRCNY) will be presented on April 19 at the 68th American Academy of Neurology (AAN) Annual Meeting taking place in Vancouver, Canada. Dr. Saud A. Sadiq, director and chief research scientist at the Tisch center, will present results of a Phase 1 clinical trial of a stem cell therapy that showed promise in people with the progressive form of multiple sclerosis (MS).

Dr. Sadiq’s presentation, “Multiple Intrathecal Dosing of Neural Progenitors Administered to Progressive MS Patients with Disability Is Safe and Improves Disability Scores,” will reveal data from a novel stem cell treatment, which proved to be safe and well-tolerated in 13 of the 20 enrolled patients with progressive MS who completed the study. Importantly, serious adverse events were not observed. Minor adverse events included transient headache and/or fever, observed in 65 percent of the enrolled patients.

The treatment protocol, involving administration of autologous mesenchymal stem cell-derived neural progenitors (MSC-NPs), is an innovative technique that allows the delivery of brain-like neural cells within 30 minutes of harvesting. MSC-NPs are bone marrow-derived cells that have regeneration potential, and have been shown in preclinical studies in mouse models of MS to be able to improve neurological function and suppress inflammatory responses.

Researchers assessed this treatment in human subjects, and found that a subset of the patients enrolled experienced neurological improvements, including improvements in the Expanded Disability Status Scale (EDSS) and bladder function.

“Repair and regeneration is possible. We have a patient who no longer needs her cane, one who has transitioned from a motorized scooter to taking steps with a walker and another who has discontinued their bladder medication as those symptoms have dramatically improved. This is the first treatment that improves established disability in patients with progressive MS and shows us there is hope that a future treatment is possible,” said Dr. Sadiq in a Tisch MSRCNY news release.

Due to such promising results, the U.S. Food and Drug Administration (FDA) has advised the Tisch center to proceed to a Phase 2 study. Dr. Sadiq’s session on the Phase 1 trial, the first to test intrathecal (IT) administration of neural progenitors as a regenerative MS therapy, is titled “Remyelination and Repair in Multiple Sclerosis (MS) Data Blitz Presentations.”

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  1. Spiro says:

    This is the only trial that has shown reversal of long established disability in progressive patients, not just RRMS. It needs to be funded and is the only hope for MS patients bec remyelination has shown very weak results thus far. The focus should be on regenerating neurons, not just remyelination which will do nothing when axons have already degenerated. It’s a shame that most neurologists know little about this trial

    • Joan Quilter says:

      Most neurologists know little about breakthroughs in MS studies, etc. I’m very impressed with this trial and procedure because it seems there is no chemotherapy involved. Most people with MS who claim to benefit from stem cells usually have HSCT which involves chemo. The only 2 places in the US that do this are Northwestern University and a Cancer Research Clinic in Seattle. My daughter went to Germany 3 years ago for stem cells w/o chemo, and it didn’t do a thing for her. But, maybe she was too disabled. I don’t know.

    • I don’t think that most neurologists keep up with current research. They just treat patients with drugs and outdated advice. I had to tell my daughter’s neurologist about a recent breakthrough discovery. My daughter who was diagnosed at age 20 (she’s now 39 and bedridden) refuses to see a neurologist. My sister, who also has MS, feels the same. They say it’s just a waste of their time. You have to be your own advocate and do the research, yourself.

    • Spiro says:

      No. Chemo is only for a blood stem cell procedure called HSCT. This is a completely different type of stem cell that aims to regenerate lost axons. HSCT reboots the immune system so it stops attacking the CNS. This stem cell therapy is the only one seen to reverse chronic progressive disability in SPMS and PPMS. HSCT is only effective in RRMS in contrast

      • Steve says:

        So this procedure would be a reoccurring event since while it does address remyelination it doesn’t affect the immune system?

        • Spiro says:

          Correct. The underlying immune system would still need to be addressed. But HSCT is NOT a cure and will not reverse chronic, progressive disability. Both strategies will be needed. Like it or not, MS is a lifetime disease like diabetes that has to be managed.

          • Steve says:

            So has there been any type of price tag associated with this procedure? I know for the HSCT there is a base of $125k.

            Also is there any indication that they are going to file for “Fast Track” status with the FDA?

          • Spiro says:

            HSCT, which I had done in 2014 in Italy, is not necessarily that expensive. In the US, it’s a different story. At any rate, I am not sure this can be fast tracked because it is not like a repurposed drug that can skip safety and dosing studies of the typical Phase I trial. As a trial, it costs nothing, unlike the stem cell clinics that are for-profit and offer no efficacy (anecdotal stories notwithstanding). A trial has to be double blind, placebo controlled, and randomized. There are no shortcuts to science. This is an unprecedented stem cell treatment that needs to go through safety and tolerability Phase I first (Phase I proved very efficacious and safe, hence why the FDA approved the Phase II). No other trial for stem cells for MS has had FDA approval in any form so far. This is the first, peer-reviewed, reputable stem cell clinical trial that is FDA approved. This is NOT a scam stem cell clinic with no science behind it, like Stemgenex or any other stem cell scams in Panama.

    • Tish says:

      Excellent web site. Lots of useful inmaifotron here. I’m sending it to several friends ans also sharing in delicious. And naturally, thanks for your sweat!

    • Spiro says:

      Stacy, it is in Phase II FDA trials in NY only and Cornell. It is not recruiting yet for the Phase II trial, but participants will have to meet trial criteria to be eligible. Unfortunately, these are the steps that are necessary before this is approved. Dr. Sadiq, if no new safety issues arise and efficacy continues, estimates it will be in clinical practice in 4-5years. I, for one, am very excited.

  2. Bea says:

    Why can’t Dr. Sadiq get funding? Organizations and private donors should be falling all over themselves to get in on this! Is the MS Society donating at all? If no, why not? This is not a cure but it is leap years ahead of anything else currently out there. It should definitely be Fast Tracked as well. MS sufferers don’t have 4-5 years to wait!

    • spiro says:

      This is an excellent question. I have been writing to the NMSS to ask why it is not being funded and I have been given the run-around constantly. They are not forthcoming with answers only to say that they need more information from Dr. Sadiq. Now, what the NMSS does is admirable in funding other projects or accessibility issues, awareness, etc but recently, they have been a mouthpiece for Big Pharma (notice all the ads placed by lifelong immunesuppressant drugs in their publications or as sponsors for example); I understand that this is part of their budget, but the results by Dr. Sadiq and his colleagues are astounding. I would ask you to kindly write the society an email, non inflammatory, asking that they fund it. I have many other groups do the same thing. The first $3million was received from private donors and grant money but he still needs $7million to continue to fund Phase II and beyond. The safety has been shown conclusively and like I mentioned above, this is the ONLY FDA approved trial for stem cells that has been shown to reverse MS damage in progressive disease, not just RRMS. The application to SCI, spinal cord injury, are obvious, too. Like you, I am very bothered but if you and people you know can write directly to the NMSS, it would go a long way Bea in raising awareness. As it stands, there are more than a dozen drugs for RRMS, none of which stop progression and none of which reverse disability at all. We have enough immunesuppressants to choose from. We need nerve regeneration, which this study shows is feasible with robust results (if you read his abstract and seminar to the recent AAN meeting, one of Dr. Sadiq’s patients went form using a motorized chair to using a walker; this just after three months of patient’s own stem cell expansion. Another is no longer using a wheelchair and brace and others have seen bladder issues resolved. I rest my case

    • Shirley says:

      Thank you very much Bea. We need more people to speak up and ask those same questions.

      This day and age do we have to beg for relief? Makes you wonder. I have wondered for going on year 28. Do they really want us to even get relief? Are these MS Societies terrified losing their inflow of money, given so willingly by Joe Public? Is Big Pharma calling the shots? Something really stinks.

      • Liz says:

        I have always thought that Shirley why would they want to put themselves out of a job. They want maintenance drugs not cures.

  3. Ken Corkran says:

    Big Pharma, in my opinion, is the most corrupt industry in America. The politicians in their back pocket should be criminally prosecuted. There is no money in the cure, just overpriced treatments that ineffectively prolong suffering. Until this travesty is corrected, the suffering will never end.
    P.S. I haven’t donated to the NMSS in years. For an organization that’s supposed to help MS patients, they may be the worst of all! Shame on you.

    • Spiro says:

      I concur. Big Pharma pays NMSS bills. I don’t donate anymore until they fund the above trial (see my post above). Their motto is, “living well with MS”. What an insult. How can you live well with this when your life has changed to one of disability and despair? MS has taken a lot from me. You better believe I have MS and MS has me.

    • Joan Quilter says:

      My daughter who has been suffering with MS for 19 years now, has told people to boycott the NMSS. Anyway, the FDA and BigPharma are in bed together.

  4. Esther Bradley says:

    This is one of the posts to receive so many comments,there must be so many people like myself who are now spms and are desperate for something to slow down this disease

  5. Bea says:

    I too just wrote to NMSS. Please everyone do the same or call. If possible use social media as well to contact celebrities who have been affected by MS like Amy Shumer, Chris Pratt, Shemar Moore just to name a few. They know people with deep pockets who can donate NOT to the NMSS but directly to the Tisch Center. It’s a long shot but it’s worth a try. If we wait for the NMSS we’ll be waiting forever.

  6. Kristen M. says:

    Stem Cells definitely helped my PPMS!
    Diagnosed 2007,with PPMS. The only thing that has kept me on my feet and functioning well is stem cell treatment from StemGenex in California.
    within 3 months, I was off the couch, functioning! Energy back, no brain fog, no bladder issues. Is my walking perfect, heck no, but..I’m still walking and driving and functioning great for someone they said would be in a wheelchair in 3 years! My PT is no longer just movement therapy, it’s Pilates, weights, and elliptical:) No more ugly atrophy legs:)
    LOVE my stem cells from StemGenex.
    Worth every penny I took from my retirement account! I’m 51 and have teenagers, still lovin life being a limpy mom:)
    If your seriously considering stem cells, I have done considerable research and found StemGenex was very professional,has a research team, and their own treatment facility. If you contact them, I am happy to speak with someone that is serious about getting treatment.
    (I am not paid for any type of endorsement, I just want others to benefit the way I have)

    • Gretchen says:

      I will second that endorsement for Stemgenex, I was diagnosed with Tumefactive MS, one lesion left me disabled. I was paralyzed on my left(dominant) side and after a year of PT-still had balance and coordination problems.
      I had treatment last July and my balance is much better, able to use my left hand and fatigue issues are gone. They are wonderful and care very much for their patients.Considering there are currently no medicines to restore function, it was my only hope.
      (I am not paid either-just my experience)

      • Liz says:

        They are located in California. They have a program that last 3 days using your own stem cells. They however do not accept insurance. The cost is very expensive. I would give it a try if I had money to burn – good luck.

    • Steve says:

      I contacted them and this is what they said,

      Thank you for your interest in our center’s Phase II stem cell clinical trial. At this time, we have not yet secured funding for Phase II, nor have we selected our study patients. As Phase II enrollment will be limited to 40 patients, we anticipate selecting patients only from the International Multiple Sclerosis Management Practice (IMSMP) and Weill Cornell.

      Updates on the trial will be available on the websites for Tisch MS and the IMSMP. “

      • Randy Burke says:

        Thanks for holding hope out there then jerking it away. International? Why publish here if you are going to be THAT selective? Thanks for nothing.

        • Spiro says:

          The “International” moniker is used to denote the guidelines they use to choose people based on their criteria for inclusion in the Phase II trial; in effect, a standardization protocol. That doesn’t mean international patients are being treated. It means they are recruiting from Tisch center and partner, Cornell . This is how research and study designs are done: you cannot treat an EDSS of 3 in an RRMS patient and a 4 in SPMS and expect to draw conclusions. I know you’re frustrated, as am I , but to rush carelessly through study designs invites failure= no FDA approval. So please, patience.

        • Liz says:

          My friend that is the life of a MS patient. You are your own advocate. When I was first diagnosed they said 10 years for a cure now 20 years later ….

  7. Jakelin says:

    I also called the Tisch Center to find out more about their second trial and they basically told me they’re waiting for fund’s and for FDA. approval. All of us suffering from PP and SP should get together and write the goverment asking for funds for the Tish Center. stems cells is the medicine for our cure.

  8. Nick D says:

    Hey Spiro,
    You are incredibly informed and on top of things. My wife Georgia has SPMS/wheelchair bound at this point. Our local neuro met Dr Sadiq in Vancouver last month and discussed my wife specifically concerning the trials and results thus far. You have to be Greek, as are we. I would like for my wife to talk with you offline if possible to do am deeper dive and share resources. Best

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