Page 60 of 291 FirstFirst ... 10505152535455565758596061626364656667686970110160 ... LastLast
Results 591 to 600 of 2901

Thread: ChinaSCINet Update

  1. #591
    Agreed
    speculation speculation speculation
    i ve been reading articles from way back in 2002 on what stem cells can potentially do to treat SCI
    but till now 2012 they have proven to do absolutely nothing.

  2. #592
    Of course it's speculation, I am after all guessing about something that has yet to occur in any way, shape or form. Hence the addition of words like "you may" or "I doubt." I just wouldn't be particularly surprised if I'm right because I know that the spinal cord is extremely fragile and I also know that clinical trials are extremely particular about their admissions requirements. I'm just advocating prudence.

    There is such a thing as sound speculation and unsound speculation. At this point, sound speculation would be something as basic and unassuming as: "garner an understanding of the science and procedural tendencies involved, because if the successes start coming, it is unlikely to be a simple cure-all and you will probably have to make decisions as a consumer, and these decisions can have very serious pros and cons."

    On the other hand, asking Mr. Young to speculate whether or not he will be able to start successful lumbosacral trials in 2013 is fairly pointless.

    All I'm trying to say here is that the scientific community over the past few hundred years has made use of things like conferences, symposiums and peer review as outlets of reasonably verified, well organized knowledge. And there is a certain formality surrounding these events that acts to pressure the researcher towards accuracy and precision and away from speculation and guesswork. Trying to bypass that process by constantly asking for tiny little optimistic glimpses into the complexities involved doesn't get you anywhere and will only frustrate you. Wait for things to be understood, compiled and shared - then the knowledge will be somewhat useful and even then, it will be extremely incremental.

    It is precisely this sort of speculation that results in Peterf's sense that he's been hearing unwarranted optimism for the past decade. Anyone that can put a timeline on this sort of stuff is wrong, period. So don't ask and don't listen when people claim to.
    L2 incomplete with a pretty bad limp since 10/31/2011.

  3. #593
    Membership Suspended fti's Avatar
    Join Date
    Dec 2005
    Posts
    557
    dear professor young

    I was in discussion with the doctor gilberto Leung since October for participated clinical trials of Hong-Kong has I made the gait the everything necessities with a lawyer of HK for a visa of 1 years and identity card of Hong-Kong to be entitled in care has Hong-Kong as (eligible persons) as he had said to it to me and finally the leung doctor says to me that my hurt and too high on irm I am really disgusted. told had to have good biceps my neurological function c5 is normal of good muscles and quite works normal and you had said to me this (For the clinical trial, we determine injury level from the neurological findings, not the MRI.)
    Last edited by fti; 03-07-2012 at 12:28 PM.

  4. #594
    fti, what was your injury level at time of accident (what vertebrae were damaged)?

  5. #595
    Membership Suspended fti's Avatar
    Join Date
    Dec 2005
    Posts
    557
    cervicales c5c6

  6. #596
    Quote Originally Posted by fti View Post
    dear professor young

    I was in discussion with the doctor gilberto Leung since October for participated clinical trials of Hong-Kong has I made the gait the everything necessities with a lawyer of HK for a visa of 1 years and identity card of Hong-Kong to be entitled in care has Hong-Kong as (eligible persons) as he had said to it to me and finally the leung doctor says to me that my hurt and too high on irm I am really disgusted. told had to have good biceps my neurological function c5 is normal of good muscles and quite works normal and you had said to me this (For the clinical trial, we determine injury level from the neurological findings, not the MRI.)
    FTI,

    The decisions regarding entry of patients into the trials are made by the investigators and not by me. I do not participate in such decisions. You should not be appealing to me concerning a decision made by the investigator of the trial. You had written to me and I told you that a neurological level depends on the neurological examination and not the MRI. The doctor can decide whether or not to include you in the trial for many reasons.

    Wise.
    Last edited by Wise Young; 03-08-2012 at 05:59 PM.

  7. #597
    Quote Originally Posted by #LHB# View Post
    Dr Wise or anyone elese who may know, how many levels of function does a trial have to show improvement on for it to be given the ok by the FDA? Is it a standard number or will 1 level be enuf? Thanks
    #LHB#

    The FDA does not impose any criterion of functional recovery for approval of a therapy for spinal cord injury. What they do require is that companies provide agreed upon data when they are sponsoring clinical trials to support claims of safety and efficacy.

    Everything depends on what the company is choosing to claim in their label. If the company claims that the treatment improves walking, the FDA will ask for a quantifiable measure of walking. For example, when Acorda Therapeutics proposed their clinical trial of Ampyra for multiple sclerosis, they designed the trial to measure the time required for patients to walk ten meters.

    You have to choose a primary outcome measure, state the criterion for better walking, get the FDA to agree to that criterion, and then show that the drug does so. You can claim that the drug reduce spasticity (which, by the way Acorda did for Ampyra in spinal cord injury) and it turned out that the drug did not reduce spasticity significantly and therefore the trial failed to prove that the drug reduced spasticity.

    When we do our phase 3 trial for umbilical cord blood cells and lithium, we will have to choose a primary outcome measure and a reasonable target for that outcome measure. It can be simply significantly better than control (untreated or other treatment) and to be "meaningful" improvement in some way. For example, I suppose that we can argue for a significant improvement if somebody recovered one segmental level of motor and sensory function.

    What the FDA requires and what takes a lot of time to provide is evidence that the treatment is what you say that it is and that it is safe. For example, if you are injecting certain types of cells into the spinal cord, you have to prove that the cells are viable, that they were made under GMP (Good Manufacturing Practice) conditions, that they are sterile and have no toxins, and that safety data is available to show that the cells do not cause cancer or other problems. Everything has to be documented.

    By the way, just because the FDA approves a treatment does not mean that the treatment will be covered by Medicare or insurance. That is a separate decision that is made by each payer and insurance company. They may decide that an FDA therapy is simply not worth the cost and not approve the treatment to be covered. This is happening more and more. In the "old days", a drug that is approved by the FDA is often immediately or rapidly approved for insurance coverage. Today, it is not a slam dunk. Companies sometimes spend many months or even years convincing insurance companies to pay for the treatment.

    Finally, just because insurance companies decide to pay for treatment does not mean that doctors will use it. This recently happened with a insulin device that provided insulin a patient can inhale (so that they don't have to inject themselves). A major pharmaceutical company spent hundreds of millions of dollars developing the device, got the FDA to approve it, and Medicare to approve coverage but doctors were not convinced that the device works as well as claimed and did not think that it was as good as the injections. So, few doctors prescribed it. The company lost money on the device and withdrew it from the market.

    Wise.

  8. #598
    Senior Member KIM's Avatar
    Join Date
    Jul 2001
    Location
    Piedralaves (Avila) SPAIN
    Posts
    1,017
    I don´t have clear that limited segment recovery, if a axon starts recovery why should it stop at the next segment and not go on to its target perhaps a toe.

  9. #599
    Quote Originally Posted by KIM View Post
    I don´t have clear that limited segment recovery, if a axon starts recovery why should it stop at the next segment and not go on to its target perhaps a toe.
    Each axon is like Odysseus. At the beginning, it is stranded far from home. The axon has to get off its duff to start travelling. It may be accompanied by a small band of other axons (axons like to travel together with the lead axon setting the path and the rest following). The little group first has to go through stormy seas (injury site) and sea monsters (macrophages). Once it crosses the injury site, the axon has another problem. There are all these neurons along the way, singing "come hither, come hither". If the axon listens to these sirens and goes to them, the brave band may never get home. So, they keep travelling, month after month. As it gets closer to home, it may stop at a neuron that is not its home and stay, like Odysseus was nearly entrapped by Circes on her island. Then when the axon finally gets home, it may find its home occupied by suitors. Indeed, we know that many local axons sprout and occupy vacated synaptic sites on neurons in the lower spinal. Like Odysseus had to throw out the suitors to reclaim Penelope, his wife, the axon may have to fight for a place on the neuron that was once its home. In the end, many axons will connect to places that were not their original home. The brain and spinal cord are "plastic" enough to use different connections to achieve function. Exercise and training will critical for recovery, by strengthening desirable connections and allowing those incorrect connections to weaken and undergo atrophy.

    The process of regeneration may take years. Regenerating axons grow very slowly. In fact, my former student Kai Liu tells me that it may take a year or more for rats to regenerate all the way from the thoracic spinal cord to the lumbosacral spinal cord. During the regeneration phase, there may not be much recovery of function. Axons that don't connect don't manifest themselves in terms of sensory or motor function. He has seen rivers of corticospional axons growing down the spinal cord after deleting PTEN in the cortex but the rats may show little or minor sensorimotor recovery.

    Does that help?

    Wise.

  10. #600
    Senior Member
    Join Date
    Sep 2006
    Location
    hampton bays new york
    Posts
    1,016
    Sounds like The Incredible Journey, with the probability of some incidents along the way. Yikes.....

Similar Threads

  1. ChinaSCINET Update
    By Schmeky in forum Cure
    Replies: 11
    Last Post: 06-16-2008, 06:25 PM
  2. ChinaSCINET on Schedule?
    By Schmeky in forum Cure
    Replies: 11
    Last Post: 01-27-2008, 05:53 AM
  3. Dr. Young and ChinaSciNet
    By Imight in forum Cure
    Replies: 17
    Last Post: 01-14-2008, 12:51 AM
  4. ChinaSCINET Schedule
    By Schmeky in forum Cure
    Replies: 4
    Last Post: 07-11-2007, 04:30 AM
  5. ChinaSCINET, On Schedule?
    By Schmeky in forum Cure
    Replies: 56
    Last Post: 01-30-2007, 03:46 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
  •