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Thread: Regeneration vs Cell Replacement Therapies

  1. #11
    George and Susan (Superstar),

    I have been giving a lot of thought to the question that Susan asked me several weeks ago... concerning what therapy I think should go into clinical trial. As Susan knows, I responded by saying that this must be a consensus decision of the clinicians. Of course I have very strong opinions concerning what therapies would be best and I make that choice every day in the laboratory. But what really matters is the opinion of the community. For too long, the community has not had a voice in what therapies should be in clinical trial. For that reason, I have been reluctant to impose my views on the community except to provide new information, to correct misinformation, and, when necessary, to try to move people away from views that may be harmful to themselves or the field. Like everybody here, I am learning and do not have a monopoly on the truth or a crystal ball to see the future.

    There are now many therapies for spinal cord injury that have been reported to be effective. Scientists are advocates for their therapies and you must always listen to their views with the knowledge that they are human and therefore biased towards the therapies they have worked on and care about. Nogo antibodies (IN-1) was the first therapy that was widely accepted as a regenerative therapy. It has been a great disappointment to me that it has not gone further than it has in the past 15 years. This was not for the lack of trying by Martin Schwab, Lisa Schnell, and others. Their particular magic potion did not attract the necessary funding and clinical support that it needed. I was very hopeful when they managed to convince Novartis to take up the cudgel on behalf of Nogo but it is still not yet in clinical trial. While they received a major boost with the identification of the Nogo gene, the nogo receptor (by Strittmatter), and demonstration that Nogo receptor blockade stimulates regeneration and improves neurological recovery in animals, the ligand and receptor technology unfortunately went to separate companies.

    We should also be very aware that scientific theories are only good for a period of time. The theory that Nogo is the main inhibitor of axonal regeneration in spinal cord injury has been overturned by the discovery that chondroitinase will stimulate regeneratioin and improve recovery as well or better than Nogo blockers. Likewise, the recent findings that increasing cAMP levels in the spinal cord will stimulate regeneration, especially when combined with cell transplants. These are the first of a series of combination therapies that will be reported this fall.

    The coming months are really crucial for the spinal cord injury community. Because of the current budgetary deficit of the the U.S. government, we should not really expect a major increase in clinical trial funding for the field for at least a year. This means that we do not have the luxury of many clinical trials. In fact, I expect that we might be able to raise funds for only a single multicenter trial for chronic spinal cord injury research in the U.S. during the coming year. The choice of the therapy and the clinical trial design therefore must be carefully chosen.

    I am really sorry we are currently in this situation. I had worked for years to avoid it but did not anticipate the 9/11 attack that essentially dried up on governmental funding of spinal cord injury research. While we have been working very hard to diversify our options by lobbying for state funds and encouraging overseas clinical trials, these remain limited. So, this places a particular onus on the decisions of the coming months. If we have one chance at a clinical trial in the coming year, what should it be?

    This is the discussion that I am hoping to stimulate in the spinal cord injury community. I believe that this is a decision that the community should have a voice in.


  2. #12
    Senior Member
    Join Date
    Mar 2002

    thank you and i personally will do everything of which you ask and believe with all of my heart and soul that you can find that hidden cure for paralysis!

    Remember that money offer, it still stands!

    Just give me your number and we can work on this...

    CCC, the ball is in our court, please play with it!

    I have my opinions, will voice them shortly..

    Gods speed for a cure~
    Susan Fajt

  3. #13
    Dear Wise,
    Thanks a lot for clarifying the situation. I'd like to apologize for my acid words concerning the research. I didn't mean to criticize any scientist working on SCIES...

  4. #14

    Congress should pass a bill instructing NIH to set up a clinical trial network for spinal cord injury and allocate funding for the network. This would galvanize NIH to put out a request for proposal (RFA) for clinical trial centers to join the network, peer-review to select the best centers, and then organize the membership of the network to meeting regularly to establish the outcome measure, the treatment that would be tested, and the clinical trials that would be carried out. The network selects a data-coordinating center that will collect the data and enforce the protocol. This may take a year or so to do, if the money were allocated.

    The path is clear but the will is simply not there in Congress.


    [This message was edited by Wise Young on 08-03-04 at 03:50 AM.]

  5. #15
    "The path is clear but the will is simply not there in Congress."

    This is what is so frustrating for anyone with a sci. Curing our condition is simply not trendy - we can live good lives in our chairs so why bother trying to cure it. It is our fault for creating the happy crip culture and not being vocal about wanting our bodily functions back again.

  6. #16
    So let's hypothetically say that Congress isn't in the picture... what would it take to make this happen? Is it possible to pursue this without Congress & NIH involved?

  7. #17
    Scott, the answer to your question is what happened in the past three years.

    I estimate that the NIH funds $40-60 million of spinal cord injury research grants (excluding rehabilitation). The states are funding $20-30 million. Private sector funding probably ranges from $10-20 million per year. All this totaled about $100 million per year. I believe that the terrorist attack on 9/11/01 and the ensuing economic slump significantly depressed funding.

    Phase 2-3 clinical trials in the U.S. (aimed at showing efficacy) cost between $10-20 million or more per trial. To my knowledge, no new U.S. clinical trial aimed at restoring function in spinal cord injury has started since 2001, except for the 4-aminopyridine trials by Acorda Therapeutics (currently the only company that is investing significantly in spinal cord injury research).


  8. #18
    Wise - thanks for the response.

    re: the $100M total... just for clarification, this figure is after the post-9/11 economic hit, correct?

  9. #19
    Yes, the actual budget numbers for NIH funding of spinal cord injury are no longer being given and thus I am just estimating based on projections from 2000. Wise.

  10. #20
    Senior Member
    Join Date
    Mar 2002
    bad computer..

    [This message was edited by Superstar on 08-04-04 at 11:36 PM.]

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