Potential MS Stem Cell Therapy Moves into Phase 2 Trial for 1st Time in US

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The Tisch MS Research Center of New York (Tisch MSRCNY) recently announced that its stem cell-based therapy as a potential treatment for multiple sclerosis (MS) will move into Phase 2 clinical testing after encouraging results in a Phase 1 trial, and on the advice of  the U.S. Food and Drug Administration (FDA). The decision marks the first time a potential stem cell treatment for multiple sclerosis has advanced to this stage of clinical testing in the U.S.

The FDA advised Tisch MSRCNY to continue its research after the treatment’s tolerability and safety were determined in the Phase 1 trial, with no adverse effects reported. The Phase 2 clinical trial will be a placebo-controlled, double-blind, randomized study with 40 patients in a crossover design: stem cells taken from the patients’ bone marrow will be processed to become brain-like neural cells, a method developed by Tisch MSRCNY and unique to the institution.

“Our unprecedented Phase I results have propelled us into the next phase of research,” said Dr. Saud A. Sadiq, the study’s lead investigator and Tisch MSRCNY’s chief research scientist, in a center news release. “No treatment has shown reversal of established disability until now. The objective improvement experienced in bladder function, vision and walking speed in both secondary and primary progressive MS is remarkable. We now plan to establish efficacy of stem cells as a reparative therapy in Phase II.”

Tisch MSRCNY is now seeking financial support to start recruiting its first patients, and the trial is expected to be launched in the summer of 2016.

For more information on the upcoming Phase 2 clinical trial, you can visit Tisch MSRCNY’s Research Division’s website.

Tisch MSRCNY, a nonprofit research center, works closely with its affiliated clinical practice, the International Multiple Sclerosis Management Practice, to enable potential MS treatments to move at an accelerated pace from discovery to development and testing. The center’s goal is to find the cause of MS and develop optimal treatments.

MS is an immune-mediated, debilitating, and progressive neurodegenerative disease in which the myelin sheath, the insulating cover of neurons in  the central nervous system (CNS), becomes inflamed and damaged. It is estimated that more than 2.3 million people worldwide are living with the disease.

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  1. Patricia Wagner says:

    Are you looking for MS patients for the phase 2 trials of the stem cell trial. I am interested in being considered for this trial if at all possible. Thank you for your consideration.

  2. Stacy Kelsey says:

    I just found out on Jan. 7 2016 I have MS it has attacked my brain, neck, and spine. It affected my vision,muscles on the right side, Numbness of the mouth, tongue, and whole left leg. Along with my ability to walk for a while. I still do not walk without losing my balance. I would like to know more on how one would go about being selected for Phase 11 trial? I have only had a 3 day infusion. Other than that I am pretty much clueless. I have been researching what I can on line. I would not wish this on anyone and would love to be Normal again.

  3. Flaria LaCourse says:

    I have RRMS and would like to be considered to take part in the clinical trails for stem cell-based therapy. Who do I contact or what do I need to do?

  4. jackie morales says:

    I have primary progressive. And this sounds like a miracle so glad that finally a treatment with stem cells is working for PP and SP. Please provide more info as far as how to be a candidate for this procedure.. I can’t wait to be able to recuperate and better my walking . I feel like I’m trapped in a 80yr old body. Just to be independent and just have a normal life. I pray night and Day. No one knows what to live with ms is only those that have this horrible disease.

  5. douglas johnson says:

    my daughter has spms , was hit really hard after the birth of her son 7 years ago, and is in a wheel chair, she is 41 years old, she exercises and eats healthy, waiting for the day this will be available to her. Please let us know how soon this will be available.

  6. Carolynn Bergamaschi says:

    My daughter was diagnosed with Multiple Sclerosis since 1985. She has gone through many treatments and meds over the years. She began having exacerbations when she was 17 years old when she was a competitive ice skater. She is now 47 years old and is confined to a wheelchair and no longer has the use of her hands or legs. She can move her head and is a brilliant bookkeeper. She is a fighter. She has two neurologist, one at Stanford Hospital and one at UC San Francisco. I would like to know when a Stem Cell trial would be available in the San Francisco Bay Area since her doctor said that may be the only thing that would help regain her mobility. Please advise

    • Paul Ojakian says:

      I am one of three in my family with MS. My Dad is deceased but my sister and I are interested in a trail. There is a facility in Simsbury CT named after my family called Ojakian Commons. It houses MS sufferers and those with learning disabilities.

  7. Sandra Weaver says:

    I have PPMS and would like to be considered to take part in the clinical trails for stem cell-based therapy. Who do I contact or what do I need to do?

  8. Lisa Williams says:

    Did anyone find out how to apply for this?? I’ve failed 4 MS drugs now and was just told there was nothing they could do for my eyesight – that I would go blind 😕


    I was diagnosed with RRMS in 1991. It is now SPMS and I am in a wheelchair. I would love to be in a stem cell clinical trial. I live in Arizona and we have the Prestigious Barrow Neurological Institute here. Let’s GET THIS GOING ALL OVER THE U.S.!!

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