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Thread: A fervent wish for the coming year

  1. #51
    DA, I am not sure what it is that you would like to do. It is not easy to "throw the book away" if other people are operating by the book. The system in the United States is one that is being adopted around the world. It requires a series of clinical trials to demonstrate safety and feasibility, followed by optimization of the treatment in phase 2, and then proof of efficacy in phase 3 trials. This system was put into place during the early 1980's. It provides a rigorous path for therapy development that is accepted in the United States.

    Scientists and clinicians in the United States and Europe operate by these rules. The rules are also being applied now in China. While doctors in China may have a little more freedom, I think that this is illusory and not as much freedom as we think. In China, because doctors are not wealthy and there is no system for malpractice suits, punitive proceedings that are brought against doctors believed to have practiced irresponsibly are actually more onerous than in the United States. Doctors are put in jail for malpractice or, at best, they may be fired and blacklisted.

    Regarding Dr. Lima, he has done four patients and his work has not been ignored. He has simply not published his work. How can you claim that he is being ignored when he has not published his work? There is no way that doctors here would know about the work. In fact, nobody here would know about the work if not for the reports of individuals posting on this site. Likewise, Dr. Huang and Dr. Zhang have not yet published their work in western journals. I understand that Dr. Zhang is planning to do so and I know that Dr. Huang will do so.

    Wise.

    [This message was edited by Wise Young on Jan 06, 2003 at 05:05 PM.]

  2. #52
    Personally I'm very thankful for the likes of Drs. Lima, Zhang, Huang, Kawaguchi, Kao, Cheng, etc. When they publish their information the potential for clinical trials increases as everyone learns more. And in the meantime if any of us do get desperate enough we can go to these guys (and others) and try an experimental surgery with no guarantees and all the risks attached. That's our (yours and mine) prerogative.

    DA, Cjo, you may want to make flippant comments to me, Sue, Wise and others about loving "excuses" and how we're blind to what is so obvious to you but do you really think that any of us don't want a cure any worse than you do? That we're not as frustrated as you two? And if we could we wouldn't speed up the process? C'mon, are we making excuses or living in the reality of the structure designed (i.e. clinical trials) around us?

    In a fantasy world every promising sci therapy from ginger root and indian raindance to shark embryo and omentum would be greeted with 1000 willing patients, a huge unlimited budget, no malpractice risk and free hospitalization. The reality is just the opposite. If you don't like the reality change the system to your liking. But is that uphill battle (reinventing the system) easier or harder than trying to make the current system better and more efficient?

    To quote JFK (Profiles in Courage) "We have to get along to go along".

    Progress in anything (e.g.sci research, etc.), whether we like it or not, in this country is about compromise. It's not an excuse. There are two sides to every issue and noone ever completely gets their way without giving a little to get a little (our political system right or wrong.)

    So, is it better to have 100% of nothing or 40% of something? The clinical trial system may not be 100% but at least (for the majority) we have it and it works. Is it perfect, no. What is? So, instead of finding fault with everyone and everything currently involved in sci cure / recovery how do we realistically and reasonably make it better?

    Fortitudine Vincimus
    (Through endurance we conquer)

  3. #53
    Senior Member dogger's Avatar
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    DA and CJO .

    this line of thinking just seems to be a continual rehash of what we have heard before . like most others here a ''cure'' cannot happen quickly enough for me , particularly as i feel my age is starting to be an issue .
    i am guessing Dr. Young and other researchers get very frustrated at times with the parameters insisted upon by bureaucracy. i would like to know whether either of you have done anything to try to change these parameters ? lobbied politicians , organised petitions etc . it is very easy to sit back and make comments aimed at people who are trying to achieve something . to be taken seriously you have to back up your words with action . i look forward to hearing what you have done to try to achieve what you think should be changed , maybe there are others here who could assist you in what you have already started .

    thank you
    dogger

    every day i wake up is a good one .

  4. #54
    This is a key comment from Wise as to why there are no treatments available yet:

    "Would you do it??

    I am assuming that you are referring to me personally. The answer is no because I don't think that there are any therapies right now that has been proven to work in humans. That is what clinical trials are for."

    There are no proven therapies yet.

    I wonder if there are there any therapies that have been tested on animals to the extent that they should be in a human clinical trial but so far are not?

  5. #55
    Chris2,

    Here goes another list of therapies but I am grateful that you asked because it raises the question of what therapies are promising that have not been taken to clinical trials. To tell you the truth, it is surprising how many have gone to clinical trial with relatively slim animal data. Probably, people here can come up with a few other suggestions.

    Many of the therapies that have shown some promise in animal studies have gone to clinical trial although not all in the U.S.

    1. omentum transfer (Boston)
    2. human fetal spinal cord (Gainesville, Stockholm)
    3. fetal OEG (Beijing)
    4. olfactory mucosa (Lisbon, Brisbane)
    5. alternating currents (Purdue)
    6. activated macrophages (Proneuron)
    7. human fetal stem cells (Moscow, Novosibirsk, Beijing)
    8. peripheral WM nerve bridge plus growth factor cocktail (Taiwan)
    9. peripheral nerve bridge from cord above injury to spinal root (Shanghai)
    10. bone marrow stem cells (Sao Paulo)

    Several therapies that have not been tested in animal studies but have been taken to clinical trials
    1. AIT-082 (no work has been published regarding AIT-082 in animal SCI)
    2. Porcine fetal stem cells (Diacrin in St. Louis, Albany)

    Several therapies that have shown some promise in animal studies but have not yet been applied in clinical trial because there has not been sufficient data or funding to move these therapies into clinical trial.
    1. chondroitinase ABC (this may cause inflammation)
    2. IN-1 (Novartis)
    3. inosine (Boston Life Science)
    4. porcine OEG (Alexion)
    5. combination neurotrophins (Genetech, Amgen)
    6. human embryonic stem cell transplants (McDonald at Washington University)
    7. Schwann cell transplants (Miami Project)

    The question is whether any of the last seven are ready to go to clinical trial. Note that I did not mention 4-AP because it is not aimed at regenerating the spinal cord. Likewise, I did not mention a number of therapies that have shown positive animal results for demyelinating conditions and are being prepared for clinical trial (such as M1).

    Wise.

  6. #56
    Guest
    Clinical trials are important, I just think that people are being helped now and that's more important than doing things by the book. I have no doubt that clinical trials will help to find the most effective treatment. I'm not so naive to think that it isn't going to take many years to do so. I know that clinicians are working hard toward this goal, but in the meantime Dr. Huang is helping people without following "the book."

    I haven't been around these forums or injured nearly as long as some of you, but I'm just learning how slow the system works and it frustrates me to no end.

    Wise,
    Do you think others in China will adopt Dr. Huang's technique to lighten his burden? I have been reading with interest about Dr. Zhang, but would that be irreversible or detrimental to a patient should an effective regenerative therapy come along(sooner rather than later)?

    I know your not in the business of predictions, but what do you feel the earliest possible date for ESC or OEG clinical trials(hopefully Phase II) in the U.S.? And who,(level, age, years post, etc.) in your opinion, is the optimal candidate?

    I think DA is right on the money when he said that if a major breakthrough happened in the U.S., the media would love it, especially if the cost justification and ROI were presented to the taxpayers.

  7. #57
    cjo,

    Dr. Huang told me that he will be training other surgeons to carry out the procedure in China. When he first started, many of his colleagues were quite skeptical. I think that many more of his colleagues will start to join the clinical trial when he publishes his data.

    Dr. Zhang's procedure is interesting. Satish was not clear concerning which and how the L1 root was anastomosed with the nerve bridge from above the injury site. I don't know if he did a end-to-end anastomosis or an end-to-side anastomosis with the L1 root and whether the root was posterior (sensory) or anterior (motor). So, it is hard to say whether there was any irreversible damage.

    Regarding predictions of clinical trial results in the U.S., like everybody else, I am eagerly awaiting the results of the AIT-082 (Neotherapeutics trial) and the AC current trial. My guess is that these results will not be definitive since both of them involved treating patients within the first 2 weeks after injury and we know that many patients will show some recovery during the first year or two after injury. It will require a randomized controlled study with fairly large numbers of patients to prove efficacy. The activated macrophage trial is starting in the U.S. and I don't know whether it will show benefit. So, I don't think any of the trials will show convincingly positive results.

    I believe that there is strong interest in OEG transplants in the U.S. and this interest may lead to OEG transplant trials in the U.S. after Dr. Huang reports his data and the Brisbane/Lisbon trials report safety data from the nasal mucosa transplant. Because of the difficult of obtaining fetal OEG cells in the U.S., perhaps the trial will focus on nasal mucosa transplants. I don't know. Perhaps there may be bone marrow stem cell transplants in humans because it is feasible, especially if the Sao Paulo study shows any promising results.

    By the way, there are other clinical trials starting up. For example, from my last visit to Japan, I met a substantial number of Japanese clinicians who are very interested in OEG and also fetal stem cell transplants. They have been working very hard to develop the data and I would not be surprised if they start both clinical trials (the OEG trials in Hokkaido and the fetal stem cell trials in Tokyo).

    Wise.

  8. #58
    Guest

    For the record

    Early on in this thread I posted the following statement:
    I read posts from yourself and others on this forum several times a day. I believe the main delay on the cure for SCI is not funding, ethics, or politics. It's the unwillingness of scientists to take a chance.
    I then posed the following scenario:
    If a patient could supply:
    -the proper source for cells(ESC, OEG, or otherwise)
    -a location outside of the U.S. to avoid the FDA hoopjumping
    -all of the funding needed for the procedure and care(no cost to you)
    -a legal document releasing you of any liability in case something went wrong

    Would you do it??
    Wise answered with the following statement:
    The answer is no because I don't think that there are any therapies right now that has been proven to work in humans. That is what clinical trials are for.
    I know all of you can read for yourselves and this is not a personal attack on Wise. I am merely trying to show what our biggest obstacle is: unwillingness to take a chance. The preceding statements strongly support this. I am very encouraged to hear that other clinical trials will be starting, even if they are outside the U.S. I eagerly await the data from the Brisbane/Lisbon trials, as I think obtaining cells from the nasal mucosa is the best chance to start clinical trials in the U.S.

  9. #59
    Senior Member Duran's Avatar
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    cjo33, I agree with you and am feeling frustrated as well.

    I am very encouraged to hear that other clinical trials will be starting, even if they are outside the U.S.
    Please, could you be more specific? Which clinical trials you are referring to?

    Joe

  10. #60
    Senior Member Schmeky's Avatar
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    Unwillingness to take a chance. . . . .

    Yes, absolutely. I stated previously that someone/body is going to have to cross the line, take a chance, break the rules. Look at clonaid (that I do not condone), they are basically offering the financially endowed believers a form of immortality (if proven valid). Dr. Lima and Huang are potentially on the verge of becoming historically immortal and appear to be unencumbered by a litigous society. Good for them and us. We need these guys to submit their respective reports on the results of their procedures. These guys and their patients are taking a chance for the worldwide SCI community. Rest assured that the first valid report of a chronic SCI gaining ambulation via regeneration/physical therapy, I will be attempting to sign on. There is simply not enough money in research and subsequent application of a therapy in the US to move forward "aggressively", not to mention the attorneys all to willing to sue if something doesn't go perfectly. I believe if one of the presidents immediate family members were stricken with SCI, progress would occur at a blistering pace.

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