Boston and San Francisco Hospitals Will Take Part in Phase 3 Trial of NurOwn for ALS

Boston and San Francisco Hospitals Will Take Part in Phase 3 Trial of NurOwn for ALS

Massachusetts General Hospital in Boston and California Pacific Medical Center in San Francisco will be among the sites where ALS patients will take in a Phase 3 clinical trial of BrainStorm Cell Therapeutics’ NurOwn.

The trial will begin after the company receives approval from the U.S. Food and Drug Administration and the government’s Institutional Review Board, which looks at ethical considerations of proposed research.

“It is a privilege to be working with Mass General once again and to welcome CPMC [the California Pacific Medical Center] as a new clinical site in our Phase 3 trial,” Chaim Lebovits, BrainStorm’s president and CEO, said in a news release. “We are excited to be taking the final steps towards U.S. launch of this trial and will be announcing the participation of other hospital sites in the near future.”

NurOwn is an individualized stem cell therapy. Researchers collect mesenchymal stem cells from patients, then grow them in a laboratory. These cells have the ability to transform into other types of cells, giving doctors a valuable source of the patients’ own specialized cells for the treatment of ALS and other illnesses.

BrainStorm has tested NurOwn in three clinical trials involving a combined 75 amyotrophic lateral sclerosis patients. Two are in Israel (NCT01051882 and NCT01777646) and one in the United States (NCT02017912).

A Phase 2 trial covering 48 ALS patients showed that NurOwn was able to stop and in some cases reverse the progression of ALS over six months. It was also safe, and patients tolerated it well.

“Prior studies of NurOwn showed promising biological and clinical effects,” said Dr. Merit E. Cudkowicz, chief of Neurology at Massachusetts General Hospital. “Based on the results of the Phase 2 trial in which we participated, a larger confirmatory trial that incorporates repeat dosing is warranted. I look forward to working with Brainstorm on this pivotal study.”

“We are all excited about the potential of stem cells for ALS, but the results to date with NurOwn are especially promising,” said Robert Miller, director of the Forbes Norris ALS Research Center at California Pacific Medical Center. “The clinical impact observed to date, along with potential biomarker findings, make this upcoming Phase 3 trial one of the most exciting ALS clinical trials ever.”

29 comments

    • Tim Bossie says:

      Hi Charlie. We do not know of any timetable. These trials can take at least two years to begin to get data that is good to evaluate.

  1. Steven says:

    How can I be a part of the trial I also would like to get back to normal so that is why I’m interested in the trial? Would my neurologist sign me up or do I have to go to clinical trials.gov

    • Tim Bossie says:

      Hi Steven. You can definitely go to clinicaltrials.gov, but we would recommend talking with your doctor about this first.

      • David says:

        Hi Tim,
        I am a very recently diagnosed 50 year old male and I’d love to participate in this study. I live in Charleston, SC. Is it possible for me to travel to the Mass. or will there be a site selected in the Southeastern United States? I am currently seeing Neurologists at Medical University of SC and in Charlotte, NC. Thank you any advice you can give me would be much appreciated.

  2. Pam Haas says:

    My question is can my husband be in the phase 3 trial, he was in the phase 2 trial at MAYO Clinic and did very well!

  3. Steven says:

    Why does it have to take two years ALS patients need this to get started asap. I thought that the FDA approved and green lighted for a phase 3 trial to supposed start last month?

    • Marie Hanley says:

      I would like to know the same question.
      Isn’t it true the longer u wait the worse it is for ALS patients

  4. Douglas Scott says:

    My spouse died of ALS related breathing issues on July 15 after struggling with the disease for over 6 years. I wish you Godspeed for a successful trial.

  5. Shaelyn weiler says:

    Please my daddy can’t leave us. He is choking everyday and it’s horrible. Someone please help. Why can’t they understand it’s bad. Our family needs our daddy. This is a nightmare. God please don’t take my dad please!

  6. Tonie says:

    I would love too participate to the trial
    But I live in Quebec Canada
    I have als for six years
    God i wish so much to participate

  7. Pam Haas says:

    Hi Steven, my husband did very well from the nurown!But suppose he can’t take part in the phase 3 trial which I can’t understand! You would think they we would want to see if phase 3 would work too!! Since there aren’t many options for this desese! Very very upsetting!! Good luck to you steven!

    • Steven says:

      Hello Pam thanks for the good news you don’t know how much it means to me to know that an ALS patient did well with a treatment, I hope I will be able to walk again and I hope Mr. Haas continue to get even better. Also I think that Brainstorm should keep former patients and continue the research to show that it works. Tell Mr. Hass to let other ALS patients know that God has help coming.

      • Pam Haas says:

        Thank you Steven, I sure wish brainstorm would let the people in the phase 2 trial in the phase 3 trial!! Can’t understand why the can’t or won’t!! At least they have something to compare it too..when my husband did phase 2 we had nothing to compare it too now they would and we would!! I’m praying for a miracal everyday!!

  8. Lisa Thoms says:

    Hi my name is Lisa Thoms , WV. I was diagnosed in March I want to know more about research, very imterested. I am seeking and practicing organic food, chemical free, vitamins right now.I am 52 & never been ill until now. I want to do everything to make a difference. There are 4 recent ALS diagnosis in our 5,000 populated area. 5 ALS deaths in last 10 yrs. 6 or so ALS diagnosed in neighboring towns.

  9. Becky Baker says:

    It would be so wonderful if all ALS patients had stem cell therapy available to them across the world but of course we don’t. Yes I have ALS and was excited to here about it but not now because it could take years to get approved for all patients and we don’t have that many years to wait.

    • Steven says:

      Exactly Becky that is why I say that the FDA need to use the benefits that President Trump said they have the power to approve treatments very faster now. So I want them to do so!

      • Craig Reagan says:

        We need to all band together and tweet President Trump, VP Pence, Tom Price, Scott Gottlieb, First Lady, KellyAnne Conway, Sarah Huckabee Sanders, and more EVERY SINGLE DAY! I have been but I need more “voices” along with me. I have an email for Dr. Peter Marks at the FDA as well. Contact your Senators and local Representative as well. If we are loud enough, they will have to heat us. We need to be a very loud collective voice. My twitter handle is CraigReagan2. Let’s make some noise!

  10. Steven Muench says:

    I looked on clinical trials. Gov and could not find brainstorm. I already have the support from my neurologist for this trial. How do I sign up?

  11. Jason Michael Woolsey says:

    My Son was just Diagnosed with ALS at 16, 1 month ago out of nowhere. He has battled Epilepsy for 8 years and now this. Any studies being done for teens as it seems to be adults only?
    Please any help here for this young man?

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