Results 1 to 7 of 7

Thread: Human Spinal Cord Neural Stem Cells for Treatment of Acute Traumatic Spinal Cord Inju

  1. #1

    Human Spinal Cord Neural Stem Cells for Treatment of Acute Traumatic Spinal Cord Inju

    Is this how works for funding?



    DR1-01446: Human Spinal Cord Neural Stem Cells for Treatment of Acute Traumatic Spinal Cord Injury
    Recommendation: Not recommended for funding

    Public Abstract (provided by applicant)
    Spinal cord injury is a devastating disease with no available treatments. It disproportionately affects young people who then lives many decades with the debilitation. In this project, we propose to develop a human neural stem cell line to treat spinal cord injury patients within 14 days after the injury. Administration of the cells into the injured tissue will limit the tissue from further damage and provide replacement neurons and glia that will promote self-repair and regeneration for the rest of the patient's life. During this project, we will assess the therapeutic as well as any toxicity potentials of the cells, using rats and pigs that will be injured in a manner similar to human spinal cord injury. These animal models will provide a rigorous testing grounds to prove or disprove potential clinical usefulness of the cells. If the cells can successfully treat rats or pigs with no major toxicity, then we will submit a IND application to the FDA to conduct a Phase 1 clinical trial with spinal cord injured patients.

    Statement of Benefit to California (provided by applicant)
    The proposed research is to develop a stem cell therapy to treat spinal cord injury patients in the acute phase after the initial injury event. By intervening early, benefits of the stem cell transplantation to the patients are likely to be greatest. Thus, the patients in the trials will require intensive care and thus only the local population within California could participate. The treatment requires surgery and invasive injection of the cells into the injury site, which will require a special training. Thus, the benefit to the State of California is first access to this therapy for about 2-3 years before it becomes available elsewhere. Secondly, California has two federally funded Regional Spinal Cord Injury Care Centers that research various aspects of rehabilitation after spinal cord injury. Conducting clinical trials in California will become further catalysts to strengthen statewide treatment and rehabilitation centers for spinal cord injury patients.

    Review
    The applicant proposes to use a human neural stem cell (hNSC) line for the treatment of acute spinal cord injury (SCI). The proposed studies are designed to provide proof-of-principle (POP) and non-clinical safety toxicology data in small and large pre-clinical animal models of contusion SCI. The hNSC line has been manufactured under current good manufacturing practices (cGMP) with a sufficient bank of clinical grade cell doses for clinical application, and an Investigational New Drug (IND) application for use of this cell line in Amyotrophic Lateral Sclerosis (ALS) is now under review by the FDA. Based on the studies performed for the ALS indication and studies in ischemic SCI models, the applicants expect that these cells can be injected intraspinally and will successfully engraft, fill the injured spinal cord cavity, and potentiate long-term neural plasticity and synapse formation.

    The proposed preclinical plan includes POP and safety studies that support the clinical objective to treat acute SCI within 14 days of injury by injection of the banked NSCs into the site of injury during the decompression surgery that is often performed to treat these patients. The POP studies will monitor clinically relevant improvements in rodent and porcine models of contusion SCI. The safety studies will evaluate multiple parameters including the injection protocol, the dosing scheme, and tumorgenicity. As the applicants propose to use allogeneic hNSCs without donor matching, an immunosuppressive (IS) regimen will be evaluated concomitantly with the proposed POP and safety studies.

    Reviewers considered the potential impact of a treatment for acute SCI to be significant and commented that the IND-enabling activities were complete and the timelines reasonable. However, the reviewers' enthusiasm for this application was minimal due to the absence of preliminary data demonstrating POP in acute SCI and concerns regarding the clinical application of the proposed therapeutic.

    read...

    http://www.cirm.ca.gov/ReviewReports_DR1-01446

  2. #2
    Senior Member DA's Avatar
    Join Date
    Jul 2001
    Location
    beaumont tx usa
    Posts
    32,389
    Spinal cord injury is a devastating disease with no available treatments. It disproportionately affects young people who then lives many decades with the debilitation. In this project, we propose to develop a human neural stem cell line to treat spinal cord injury patients within 14 days after the injury.
    What about the many people who live many decades with the debilitation?

    oooh, you keep them around to be used to make money...

  3. #3
    We got to run this by Wise as we are all chronic and well beyond 14 days.

  4. #4
    Quote Originally Posted by manouli View Post
    Is this how works for funding?

    http://www.cirm.ca.gov/ReviewReports_DR1-01446
    I am not sure that I understand your question. This grant application was not recommended for funding by the California Institute of Regenerative Medicine (CIRM). Many grants are turned down by funding agencies. At NIH, only about 10% of grant applications are funded. Wise.

  5. #5
    Quote Originally Posted by Wise Young View Post
    I am not sure that I understand your question. This grant application was not recommended for funding by the California Institute of Regenerative Medicine (CIRM). Many grants are turned down by funding agencies. At NIH, only about 10% of grant applications are funded. Wise.

    i mean regarding the application process. What they want to see in order to approve it?


    thank you, manouli.

  6. #6
    Quote Originally Posted by manouli View Post
    i mean regarding the application process. What they want to see in order to approve it?


    thank you, manouli.
    The application was not funded because there is only enough money for about a quarter of the applications. The critique of the application provides details of the deficiencies. The applicants need to reapply.

    Wise.

  7. #7

    Smile

    Quote Originally Posted by Wise Young View Post
    The application was not funded because there is only enough money for about a quarter of the applications. The critique of the application provides details of the deficiencies. The applicants need to reapply.

    Wise.
    Thank you very much Dr. Young. I cannot believe many times that how much power the MONEY has.

Similar Threads

  1. Replies: 0
    Last Post: 02-08-2010, 05:16 PM
  2. Replies: 3
    Last Post: 09-19-2003, 07:46 PM
  3. Replies: 0
    Last Post: 09-08-2003, 07:41 AM
  4. Replies: 3
    Last Post: 05-23-2002, 05:30 PM
  5. Replies: 9
    Last Post: 03-03-2002, 09:32 PM

Posting Permissions

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