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Thread: W2W - Boston

  1. #1
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    W2W - Boston

    Why not invite Dr Young and others actually with some know-how on SCI trials?

  2. #2
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    Many of the ones invited don't know how to do a simple laminectomy.

  3. #3
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    So then, how at all to be able to discuss any trials?

  4. #4
    Super Moderator Sue Pendleton's Avatar
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    I'll be there because I'd like to hear where NeuralStem is currently in their trials for ALS. Mr Garr, the CEO, and then COO, Chris Copple supported the Maryland SCI Research Law through every hearing. They are in trials for ALS now and have been planning trials on SCI once they perfected a useable motorneuron replacement cell. Leif, they have experience.

    I'd also like to hear Dr Blackmore again because his approach to the problem of paralysis is very different from most I've heard or read about elsewhere.

    I don't know if Dr Silver is still on Acorda Therapeutics's scientific advisary board but he was at the time I went through their 4-AP phase 2A for incomplete SCI. Wise was also on the Acorda board then. Since Acorda is doing better than most biotechs on the NASDAQ stock exchange I think they knew what they were doing back then and now.

    We also plan on visiting some friends and family while we're back east.

    Finally. the following week is the First Friday in October at Rutgers and we're planning on being there and hearing from Wise on the progress made on the China and, hopefully, US trials.
    Courage doesn't always roar. Sometimes courage is the quiet voice at the end of the day saying, "I will try again tomorrow."

    Disclaimer: Answers, suggestions, and/or comments do not constitute medical advice expressed or implied and are based solely on my experiences as a SCI patient. Please consult your attending physician for medical advise and treatment. In the event of a medical emergency please call 911.

  5. #5
    Quote Originally Posted by Sue Pendleton View Post
    I'll be there because I'd like to hear where NeuralStem is currently in their trials for ALS. Mr Garr, the CEO, and then COO, Chris Copple supported the Maryland SCI Research Law through every hearing. They are in trials for ALS now and have been planning trials on SCI once they perfected a useable motorneuron replacement cell. Leif, they have experience.
    FDA approved Phase I safety trial transplanting NSI-566 into the T2-T12 lumbar regions of chronic SCI patients, in January 2013. Phase I commencement is expected in the third quarter of 2013 so the timing should be perfect!

    This trial will enroll up to eight cSCI patients with thoracic spinal cord injuries (T2-T12), who have an American Spinal Injury Association (ASIA) grade A level of impairment one-to-two years post-injury. ASIA A impairment refers to a patient with no motor or sensory function in the relevant segments at and below the injury, and is considered to be complete paralysis.

    The primary objective of the trial, expected to commence in the third quarter of 2013, is to determine the safety and toxicity of human spinal stem cell transplantation for the treatment of paralysis and related symptoms due to cSCI. The secondary objectives of the study are to evaluate graft survival in the transplant site by MRI, as well as the effectiveness of transient immunosuppression. Additionally, the study will look at exploratory objectives to evaluate the ability of NSI-566 transplantation to positively affect AIS level, ISNC SCI motor and sensory index scores, bowel and bladder function, pain, UAB IMR scores, SCIM scores, evoked sensory and motor potentials, and electromyogram (EMG).

    All patients in the trial will receive six injections in, or around, the injury site, using the same cells and procedure (with Neuralstem’s proprietary Spinal Cord Delivery Platform and Floating Cannula) as the company’s ALS trial. The first four cSCI patients will receive 100,000 cells per injection; the second four patients will receive 200,000 cells per injection. All patients will also receive physical therapy post-surgery to guide newly formed nerves to their proper connections and functionality. The patients will also receive immunosuppressive therapy, which will be for three months, as tolerated. The trial study period will end six months post-surgery for each patient, with a one-year Phase I completion goal.
    Last edited by GRAMMY; 05-19-2013 at 12:10 AM.

  6. #6
    Senior Member muskie's Avatar
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    I plan on going this year, very excited
    Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

  7. #7
    Quote Originally Posted by Leif View Post
    So then, how at all to be able to discuss any trials?

    Why discuss human trials before there has been success in an appropriate big animal (preferably primate) injury model?

    (ex: if the human trial population includes chronic, complete, and contusion injured, then the animal model should be chronic, complete, and contusion.)

  8. #8
    Senior Member lynnifer's Avatar
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    Quote Originally Posted by GRAMMY View Post
    FDA approved Phase I safety trial transplanting NSI-566 into the T2-T12 lumbar regions of chronic SCI patients, in January 2013. Phase I commencement is expected in the third quarter of 2013 so the timing should be perfect!
    I can't begin to describe how great it feels to see more than one - more than two - trials seem to be occurring. Didn't think I'd see the day ... but whoop here it is!
    Last edited by lynnifer; 05-19-2013 at 01:02 AM.
    Roses are red. Tacos are enjoyable. Don't blame immigrants, because you're unemployable.

    T-11 Flaccid Paraplegic due to TM July 1985 @ age 12

  9. #9
    Quote Originally Posted by Sue Pendleton View Post
    I'll be there because I'd like to hear where NeuralStem is currently in their trials for ALS. Mr Garr, the CEO, and then COO, Chris Copple supported the Maryland SCI Research Law through every hearing. They are in trials for ALS now and have been planning trials on SCI once they perfected a useable motorneuron replacement cell.
    The Company has completed its first trial in humans, a 15 patient phase I trial in amyotrophic lateral sclerosis or ALS. Results of this trial have indicated that the surgical procedure used to implant the cells and the cells themselves are safe, which is the critical first step. Importantly, there have been encouraging signals of efficacy in this dreadful disease which is invariably fatal and for which there is only one approved drug; Rilutek extends life by three months or so in some younger patients, but has no effect on quality of life. Most ALS patients die within three to five years of diagnosis and during that time they suffer a horrible deterioration in quality of life. There is a desperate need for effective therapy.

    The clinical trial program has now gained traction. The FDA has given the go-ahead to begin a phase II trial in 18 patients. This has been a long journey for Neuralstem as the Company was founded in 1996. It took over a decade to develop a product for clinical trials and as the pioneer in neural stem cells, clinical trial progress was slowed by FDA concerns about the safety of the surgical procedure and the cells themselves. The phase I trial in ALS was started in January of 2010 and took over three years to complete. In addition to this program there are four other clinical trials using its neural stem cells that will likely begin in 2013: (1) a phase I/II trial in ALS in Mexico, (2) a phase I trial in chronic spinal cord injury in the US, (3) an ischemic stroke phase I trial in China and (4) a phase I trial in acute spinal cord injury in South Korea. The first part of the phase I study in ALS allowed a meaningful evaluation of efficacy in five patients.

    I think that the efficacy and safety data known so far about the five patients from the first part of the phase I is quite significant. The FDA appears to agree as it has given the go ahead for an 18 patient phase II trial in ALS that will begin in 2Q, 2013. Given that the FDA already knows the efficacy data that we are now waiting on, when presented it is unlikely to have any negative surprises. The Company will not comment on time to completion of the soon to begin phase II trial nor the phase III that would follow if it is successful. My estimate is that the phase II could be completed by mid to late 2014 allowing for the phase III to begin in late 2014 or early 2015 assuming positive results in phase II.

    http://smithonstocks.com/neuralstem-...rial-cur-1-18/

    http://wamu.org/audio-player?nid=78461 AUDIO

    This trial will be easy to recruit. Readers may recall that Geron was only able to recruit two patients in three years into their spinal cord injury trial because it was an acute spinal cord injury trial. However, the patient had to be treated immediately after their accident so that unless the accident occurred near an investigational site and they were brought there for stabilization, they were not eligible for the trial. Neuralstem will be treating patients who have been stabilized. They can be transported over some distance to the four to five centers participating in the trial. They will be doing surgeries at Grady in Atlanta where the principal investigator, Keith Tansey, works. The other sites are likely to be Philadelphia, Milwaukee, Miami and San Diego.

    Keith Tansey, MD, PhD, Director, Spinal Cord Injury Research and Restorative Neurology Programs, Shepherd Center will also be speaking at Working 2 Walk Boston 2013.
    Last edited by GRAMMY; 05-19-2013 at 12:28 AM.

  10. #10
    Super Moderator Sue Pendleton's Avatar
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    Quote Originally Posted by NowhereMan View Post
    Why discuss human trials before there has been success in an appropriate big animal (preferably primate) injury model?

    (ex: if the human trial population includes chronic, complete, and contusion injured, then the animal model should be chronic, complete, and contusion.)
    Speaking privately to several researchers over the years I have found few wish to advertise if they have done any primate studies due to PETA. I have no idea what therapies the FDA requires primate studies on and whether that information is open to public scutiny because of security concerns. I do know that innocent people have been injured by acts against institutions that do animal research, even when the research can also help the animals, by extremist groups. IOWs, just because it's not in a press release that doesn't mean it hasn't been done.

    Thanks for the updated background GRAMMY. NeuralStem was still in an incubator program at the University of Maryland in 1999 and 2000 when I was introduced to them and what they were aiming to do. I am amazed they have gotten this far without running out of money. They must have some seriously big angels behind them.

    Hope to meet you in Boston Lynnifer or at Niagra on the way.
    Courage doesn't always roar. Sometimes courage is the quiet voice at the end of the day saying, "I will try again tomorrow."

    Disclaimer: Answers, suggestions, and/or comments do not constitute medical advice expressed or implied and are based solely on my experiences as a SCI patient. Please consult your attending physician for medical advise and treatment. In the event of a medical emergency please call 911.

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