Positive results from BrainStorm's interim NurOwn stem cell therapy clinical trial for ALS

Published on July 23, 2012 at 11:35 AM · 7 Comments

BrainStorm Cell Therapeutics (OTC:BCLI) announced today that it has completed the planned interim safety review of its Phase I/II ALS (Amyotrophic Lateral Sclerosis) clinical trial, indicating that autologous transplantation of the Company's cell therapy was well-tolerated, appears to be safe for use, and did not present any undue risks to the study participants.

“This interim report clearly documents that Brainstorm's NurOwn stem cell therapy is safe. We are absolutely delighted that, with these data in hand, Brainstorm is now moving forward into expanded studies involving trials here in Boston, Massachusetts.”

"We are very encouraged by the positive results of our first cohort of 12 patients," said Professor Dimitrios Karussis of the Neurology Department at Hadassah Medical Center Jerusalem and Principal Investigator of the trial. "This important safety and tolerability data are reassuring as we progress to the next half of this trial. Although this is an interim safety summary report documenting achievement of the study's primary endpoint, we cannot ignore some possible promising indications of clinical efficacy observed in single patients, such as a tendency towards improvement in some of the major ALS Functional Rating Scale variables."

The company is also happy to report that in some patients this pilot study demonstrated a tendency toward stabilization in some parameters in the ALS Functional Rating Scale.

The trial, which is designed to evaluate the safety and preliminary efficacy of BrainStorm's proprietary NurOwn™ cell therapy (bone marrow-derived, autologous, differentiated mesenchymal stromal cells) is being conducted at the Hadassah Medical Center in Jerusalem, Israel. The company submitted the positive interim safety report to the Israeli Ministry of Health.

The interim data was reported on the first group of patients, all of whom suffer from early stage or progressive ALS, also known as Lou Gehrig's disease. All patients enrolled were transplanted with NurOwn either intramuscularly or intrathecally.

Professor Robert Brown, Chair of Neurology at the University of Massachusetts Medical School and a world renowned expert in neuromuscular genetics and ALS, added, "This interim report clearly documents that Brainstorm's NurOwn stem cell therapy is safe. We are absolutely delighted that, with these data in hand, Brainstorm is now moving forward into expanded studies involving trials here in Boston, Massachusetts."

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  1. Ann Ann Canada says:

    I am happy tht strides are being made in curing these devestating diseases with stem cells, instead of just prolonging lives with nasty drugs with terrible side effects, but I am also FRUSTRATED that these stem cell procedures are taking too long for people living with these debilitating and devestating diseases to ever access these procedues. Many people are dying and have nothing to lose.  Why can't they access these procedures which have been supposedly benefiting peple in these trials?

  2. Kamini Kamini Australia says:

    It is so reassuring to see that the Nurown Stem Cell therapy will help patients with ALS. However when going through the website, we understand you are only halfway of the trial. Can you accelerate the trial process so that those who have ALS presently have the chance to try the therapy and possibly get cured??? As it is really frustrating to patiens with MND and ALS to just read of your achievements and no action for them. Please join forces and officialise this treatment as the family of such patients undergo nightmares since this fatal disease is diagnosed in their relative.

  3. Samer Mustafa Samer Mustafa United States says:

    Please get this nurown treatment to the us my dad is currently at mgh do to this terrible disease please help!

  4. Jenelle Van Brunt Jenelle Van Brunt United States says:

    Our 33 year old son has ALS.  He is the father of 4 young children.  He needs to be involved with this stem-cell therapy and NOW.  Is there any way to speed up this process so folks can benefit before it's too late for them?

  5. ALS
    Donna Donna United States says:

    Please hurry and get this to the US I have a 27 year old son with ALS and gradually getting worse.  Please hurry!

  6. timothy ogiemwonyi timothy ogiemwonyi Ireland says:

    I just hope this NurOwn trials are completed on time,cant bear to see my mum die of this terrible ALS.

  7. Shannon Mihalek Shannon Mihalek United States says:

    I agree that this trial is taking too long.  My mom is barely living with this horrible disease.  She is completed paralyzed and we all take care of her 24/7.  She has nothing to lose.  Get this trial to the US and start recruiting our own.

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