Results 1 to 9 of 9

Thread: Neuralstem seeks US FDA approval to begin chronic spinal cord injury stem cell trial

  1. #1
    Senior Member Duran's Avatar
    Join Date
    Jul 2001
    Location
    Maximum security prison, Death row
    Posts
    441

    Neuralstem seeks US FDA approval to begin chronic spinal cord injury stem cell trial

    Neuralstem seeks US FDA approval to begin chronic spinal cord injury stem cell trial

    Monday, September 06, 2010 15:00 IST
    Rockville, Maryland

    Neuralstem, Inc. announced that it has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (FDA) to begin a phase I safety clinical trial for chronic spinal cord injury with its spinal cord stem cells. This multicenter phase I safety trial will enrol a total of 16 long-term, or chronic, spinal cord injury patients, with an American Spinal Injury Association (ASIA) Grade A level of impairment, one-to-two years post-injury. ASIA A refers to a patient with no motor or sensory function in the relevant segments and is considered to be complete paralysis.

    "We are very encouraged by what we have learned transplanting the first six ALS (Amyotrophic Lateral Sclerosis) patients in our FDA-approved trial in Atlanta," said chief scientific officer and chairman of Neuralstem's Board of Directors, Karl Johe, Ph.D. "We believe that it is the right time to leverage what we have learned with ALS in spinal cord injury. We will be looking at secondary endpoints as well, by which we hope to measure some degree of functional recovery. As in the ALS trial, we are proposing to transplant patients with injuries in the thoracic (mid-back) regions first. Once the safety of the surgeries has been established, we plan to transplant patients whose injuries are in the cervical (upper spinal cord) region."

    Clinical studies with chronic SCI patients have demonstrated that, even several years after motor- and sensory-complete SCI, intensive and task-specific rehabilitation can improve motor function as measured by the ASIA Impairment Scale (AIS). These clinical experiences, together with results from numerous animal studies of SCI, illustrate that even the complete, chronically-injured cord can undergo some degree of recovery and reorganization. Transplantation of Neuralstem's human spinal stem cells (HSSC) is meant to provide a neuron-rich substrate to the injured segments of a patient's spinal cord to promote further repair, regeneration, and reorganization. The goal is to harness this inherent plasticity and promote reorganization by combining stem cell transplantation with the modern concept of activity-guided rehabilitation.

    Neuralstem believes that, in chronic SCI, our HSSC transplants may promote reorganization of segmental circuitry over the long-term. In the cervical region of the spinal cord, this could result in improved breathing capacity and recovery of sensori-motor functions of the upper limbs. Segmental reorganization induced by, and utilizing graft-derived neurons, may also result in improved locomotion.

    Neurons differentiated from Neuralstem's HSSC grafts in chronic thoracic injuries may serve as a bridge to connect the axons located above the site of injury to neurons of segments below the injury site. HSSC grafts may also encourage axons to regenerate through the graft to segments below the injury.

    More on: http://www.pharmabiz.com/article/det...234&sectionid=
    2016

  2. #2
    Senior Member
    Join Date
    Mar 2007
    Location
    minnesota
    Posts
    2,086
    What is the probablity that the FDA will approve this trial? How long does it take from filing the application to the start of the trial? It sounds encouraging.

  3. #3
    Duran Reading the post ; it sounds interesting. Evidently their ALS trials have shown something positive. I hope for those with that dreaded disease theywill see a new day a dawning. Eveidently they've enough postives to go ahead and apply for FDA approval for spinal injuries. Lot's of tantalizing news; we need more meat and I think it's coming.

  4. #4
    Senior Member Duran's Avatar
    Join Date
    Jul 2001
    Location
    Maximum security prison, Death row
    Posts
    441
    Quote Originally Posted by keeping on View Post
    Duran Reading the post ; it sounds interesting. Evidently their ALS trials have shown something positive. I hope for those with that dreaded disease theywill see a new day a dawning. Eveidently they've enough postives to go ahead and apply for FDA approval for spinal injuries. Lot's of tantalizing news; we need more meat and I think it's coming.
    Keeping on,

    I’m listening. I think if „the safety studies“ (Phase I) on ALS patients turns out well, the company might directly switch over to its Phase IIa. with chronic spinal cord injuries. From what I read on the ALS site it seems that the cells transplanted into the spinal cords might be safe and therapeutic dosage should be increased in the next round. If so, that’s a good news for SCI, too.

    In any case, you should be cautious and don’t get too excited about „what’s coming“ until some positive results surface. We already had had several clinical trials discussed around here (such as Proneuron, Diacrin or Alseres Pharmaceuticals) that started off, but have never „made the front page“. Seeing is believing.

    Joe
    2016

  5. #5
    Joe I agree; it does sound they are optimistic and lther trials will be starting soon also. I hope for all, that things keep progressing .O am excited on what I'm reading and watching. Seems the snow ball is rollling and things are happening.

    keeping on

  6. #6
    Senior Member Duran's Avatar
    Join Date
    Jul 2001
    Location
    Maximum security prison, Death row
    Posts
    441

    Update

    A word from Neuralstem. Yesterday, I was told that "their SCIes will only be immunosuppressed for three months. It is only the ALS patients who are *as tolerated* for life".

    With regard to the question if a participation in other trials would disqualify me, the answer is *yes*. However, "I should remember, they are only going to be transplanting patients one to two years out from injury in the first trial, and from the sound of it, I will be outside that window".
    2016

  7. #7
    Joe, I've been looking at Neralstem and others. Seems there is a time limit on all except Wise's trial. What I see with Wise trial that might expect some revcovery for completes and some trcovery for incompletes (maybe). I think the damage done over the long haul is what it is. Repair of myelin and return to exercising limbs and muscles after a period of time may be a dream or highoy irrational expecetations. I would like to be wrong but the news is slow and tantalizing, but time consumming. I think that acutes will benefit greatly in the future and chronics will br discussed after we're gone. I don't like feeling this way, but my gut is starting to feel the truth.

    keeping on

  8. #8
    Keeping On - I wouldnt worry too much about the selection criteria for these trials. Whether you are quad, para, incomplete, complete, 6 months post or 16 years post - there is something for everyone. The selection criteria is picked specifically to provide the best way of proving efficacy of a therapy on the basis of selected outcomes. And if the best way to prove the efficacy of spinal cord regeneration is to pick slightly younger injuries with less "secondary" damage to the body then so be it. That doesnt mean the therapy is not in scope for the rest of the community.

    Keep keeping on Keeping On - we cant have our resident duracell bunny losing hope.

    Fly Pelican Fly

  9. #9
    Fly, I kinda think the same. However, I'd lik ethe researchers to say it; like we are testing these criteria first, buit think inclusion of ultimate therapy will be for all. Anyway, it's coming for some if not for all.

Similar Threads

  1. Replies: 3
    Last Post: 09-02-2010, 05:52 PM
  2. Replies: 29
    Last Post: 08-29-2010, 04:58 PM
  3. Replies: 2
    Last Post: 12-22-2009, 05:06 PM
  4. Replies: 0
    Last Post: 09-21-2009, 10:40 AM
  5. Replies: 3
    Last Post: 06-11-2003, 05:14 AM

Posting Permissions

  • You may not post new threads
  • You may not post replies
  • You may not post attachments
  • You may not edit your posts
  •