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Thread: Safety Stem Cell Trial in ALS Set to Advance

  1. #11
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    Looking very positive, thanks for link Matt I will be following this with real interest.

    Sonia

  2. #12
    Forum Member MattJ's Avatar
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    Hi all,

    An update from a patient taking part in the Neuralstem trial:

    Harada joined a clinical trial at Emory University in Atlanta, where doctors were injecting neural stem cells -- the precursors to nerve cells -- into the lower spinal cord of ALS patients.

    Before the procedure, Harada walked with a cane and would get winded just by walking to the mailbox. He had to quit his job as a manager for a shredding company. He was so tired he couldn't play with his three children. He was too weak to pick up his youngest child. He couldn't even open a Ziploc bag.

    Harada hoped the treatment would help, but he didn't expect it to. However, two weeks after getting the stem cell injections in March, he says he started to feel better.
    http://edition.cnn.com/2011/09/28/he...s-encouraging/
    Last edited by MattJ; 28th September 2011 at 21:42.

  3. #13
    Forum Member MattJ's Avatar
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    Operation marks another step forward in stem cell research

    A 50-year-old man from Trion, Georgia, is the first person to be injected with stem cells in the upper part of the spinal cord, making him yet another pioneer in the scientific quest to use stem cells to heal.

    Richard Grosjean received the treatment Friday. He is part of an ongoing FDA-approved clinical trial that is testing the safety of injecting stem cells into the spinal cords of patients with amyotrophic lateral sclerosis, or ALS, also known as Lou Gehrig's disease.

    http://edition.cnn.com/2011/11/21/he...als/index.html
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  4. #14
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    Hi Matt,

    Nice to see your on the ball again and a very intresting article. Although it may not be the answer at least they are getting ways of getting vital cells or liquids into the spine without damaging the spinal cord.


    Pete

  5. #15
    Forum Member MattJ's Avatar
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    Neuralstem: surging immunosuppression?

    http://blogs.als.net/post/2012/04/12...ppression.aspx

    Researchers estimate that more than 70% of motor neurons could be lost in people with ALS just one year after being diagnosed with the disease. To stem the tide of neurodegeneration, scientists are working hard to develop neuroprotective therapies to help keep their muscles moving.

    One such potential treatment strategy, being developed by Maryland’s Neuralstem Inc., hopes to deploy neuronal bodyguards into the spinal cord that crank out protective substances which may shield the motor nerves from further destruction. The experimental stem cell transplantation procedure, performed during surgery, involves the direct injection of healthy neural stem cells into the spinal cord. The transplanted stem cells according to preclinical studies may give rise to populations of so-called interneurons that might plug directly into ALS-ravaged motor neurons, providing them life support.

    In 2010, US physicians launched a phase I clinical trial to evaluate the safety of Neuralstem’s stem cell transplantation procedure. Patients received stem cell injections in the lumbar (leg-moving) region of the spinal cord. 12 people with ALS participated.

    Now, the team reports the first results from the phase I clinical trial.

    The stem cell transplantation procedure appears to be safe and does not appear to aggravate the disease. But, the immunosuppressants prescribed to prevent rejection of these transplanted stem cells were not well-tolerated by trial participants.

    The results are published in the journal Stem Cells.

    Emory University School of Medicine neurosurgeon Nicholas Boulis MD injected up to 1 million neural stem cells into the spinal cords of 12 ALS patients post-laminectomy. Patients received anti-rejection medicines routinely used in whole organ transplants before and after surgery.

    The team found that the procedure appeared to be safe and 6 to 18 months later did not rapidly worsen patients’ condition according to ALS-FRS, forced vital capacity and other functional measures.

    But researchers discovered that ALS patients could not tolerate the immunosuppressants (mycophenolate mofetil and tacrolimus) prescribed post-surgery. Most trial participants had to drop or reduce the dosage of at least one of the two anti-rejection medicines due to chronic bloating, diarrhea and vomiting. And, 2 out of 12 patients had to be taken off both drugs altogether due to the inability to control these symptoms through other medications.

    The jury is still out however whether a personalized stem cell therapy such as Brainstorm Cell Therapeutics’ NurOwn is a better way to go – particularly for people with inherited forms of ALS. The treatment strategy, which uses the patients’ own bone marrow to generate neurotrophin-producing cells, eliminates the need for immunosuppressants. But these transplanted cells according to some experts contain potentially ALS-triggering mutations which might also further contribute to the disease.

    Neuralstem’s phase I clinical trial remains ongoing. Six people with ALS are expected to be implanted with stem cells in the cervical (diaphragm-moving) region of the spinal cord sometime this spring or summer. The trial is expected to be completed in October 2012.

    Brainstorm Cell Therapeutics’ NurOwn phase I/II clinical trial is currently ongoing in Israel. Researchers are expected to launch a phase I/II ALS clinical trial in the US sometime in 2012.
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  6. #16
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    Hi Matt,

    Thanks for the update.

    Interesting that the immunosuppressants were not well tolerated.

    Is the immune system fighting or assisting ALS??

    In light of the recent stem cell breakthrough at Edinburgh University, are we closer to injecting motor neurons that will be immune system tolerated?

    Some head scratching for the researchers.

    Best wishes

    Graham

  7. #17
    Forum Member MattJ's Avatar
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    Good news but I'm confused over the immunosuppressant issue. Is it or isn't it a problem? Maybe Neuralstem don't see it as a big enough reason to stop the trial? Especially when one of the participants has improved.

    Neuralstem is seeking permission to evaluate efficacy in its phase 1 safety trial, as well as to increase the dosage and number of trial participants.

    Although the phase 1 trial isnít currently designed to evaluate efficacy, early results reported in March noted that one participant showed signs of clinical improvement.

    Interim results, published online March 12, 2012, in Stem Cells, showed that Neuralstem's neural stem cells, and the surgical technique used to transplant them, were safe and well-tolerated in 12 people with ALS.
    http://alsn.mda.org/news/neuralstem-...tem-cell-trial
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  8. #18
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    Just thought I'd add this link as it is exciting that stem cell research is advancing quickly !!

    http://www.dailymail.co.uk/news/arti...wed-speak.html

  9. #19
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    Quote Originally Posted by MattJ View Post
    Good news but I'm confused over the immunosuppressant issue. Is it or isn't it a problem? Maybe Neuralstem don't see it as a big enough reason to stop the trial? Especially when one of the participants has improved.



    http://alsn.mda.org/news/neuralstem-...tem-cell-trial
    Hi Matt,

    Only stem cells converted from other cells in the body, known as induced stem cells, have a problem with rejection and so require imunosupressants. In this trial the stem cells were derived from the patients own skin.

    Clive
    Living with MND. There is a solution to every problem - never ever give up.

  10. #20
    Forum Member MattJ's Avatar
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    Interesting update on ALS Forums from Ted Harada, who is taking part in the Neuralstem stem cell trial.

    http://www.alsforums.com/forum/als-r...tml#post240118

    I am often hesitant to go in to to much detail about my condition for multiple reasons. I do not want to appear as bragging or complaining or providing false hope.

    My surgery was March 9 of 2011 so nearly 16 months ago. About 4 weeks after showing drastic improvements they did to an EMG an while they found a few muscles with denervation supporting the orginal ALS diagnosis as well as the 2nd opinion confirmation but they also found something that thoroughly suprised them. They found that throughout my body there was reenervation. Not just one or two spots but throughout my body. The physician who performed the EMG was was a Dr I has not seen before, Dr. Glass did that on purpose and did not tell him anything about me in order to not bias what he found. Anyway he said he had never seen anything like that. There has been talk about doing another one but they have not done it yet.

    As far as I how I am feeling, as I have stated many times, I have been blessed more then any one person deserves, believe I know how lucky and fortunate I am. So I am still not using my cane or the bipap that I used to use I am definitely slowly getting weaker again. (the progress is slower then prior to the surgery) I can really feel it in my left leg and have recently started limping again and at this rate there have been times where I have thought that if this keeps up again I will be using a cane again before I know it. My hand strength is much stronger then pre surgery but again lately I can tell a difference especially on the left side.

    I am not complaining or being ungrateful for the gift I have received. I know anyone would trade with me and believe I feel guilty and want nothing more then to be the guinea pig that helps them find the answer that helps everyone.

    The plan is to do the surgery and give me an additional 500,000 stem cells sometime in August.
    It's fantastic that Ted still retains some of his gains but is disappointing about the signs of weakness returning. It will be interesting to see if the top up in August brings back some of the loses.
    Last edited by MattJ; 11th July 2012 at 12:07.
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