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Thread: For Dr Young

  1. #11
    Quote Originally Posted by soonerborn View Post
    Dr. Young thank you for the response. Should I just wait for something else to come along? Is there another program that you would recommend another program? I really need something with a chance of walking to look forward to! Sorry to bother you with this. Thanks again for your work and answers.
    soonerborn,

    You are not bothering me at all. That is what this forum is supposed to be. If the cure were available now, we would not be having this discussion. There is no treatment in the world today that I am aware of that is curing spinal cord injury. I think that you must know this. However, this does not meant that there will not be such therapies. Given the lack of clinical trials of therapies for chronic spinal cord injury, it is not surprising that we don't have many therapies that are restoring function.

    I believe that if we stop sitting around waiting for miracles by somebody else and really put our efforts into supporting well-run and designed clinical trials to test promising therapies, we will soon have many therapies that restore function in people with chronic spinal cord injury. Everybody wants to blame somebody else for the lack of therapies. The fault is ours. Why are we waiting for others to fund the cure for spinal cord injury?

    There are already some therapies that are producing some return of function but the question is whether the return is worthwhile and who the therapies would help. In my opinion, two therapies have been shown to restore function in poeple with chronic spinal cord injury to date.

    1. For many people who had incomplete spinal cord injury (ASIA/ISCOS category B and C) and who never walked after spinal cord injury, intensive locomotor training can restore ability to walk without assistance in 70% or more.

    2. For people with chronic complete spinal cord injury (ASIA/ISCOS A), there is some evidence from China that OEG transplants will restore several dermatomes of sensory function but will provide limited motor improvements. This is the treatment by Hongyun Huang in Beijing.

    I am uncertain about the nasal mucosa transplants in Portugal. While Lima recently reported that some of his patients are beginning to recover locomotor function with intensive locomotor training many years after initial treatment, it is hard to know whether the effects are due to the training alone or the transplants.

    There are several cell therapies that I do not believe there is any convincing evidence of efficacy. These include the treatments by Beike Biotechnology in Shenzhen and associated hospitals, the so-called human embryonic stem cell therapies by Geeta Shroff, or the umbilical cord blood infusions that are being done in Mexico and the Caribbean. In many cases, the cells are not even HLA-matched and are likely to be rejected shortly after being infused intravenously or injected intramuscularly. It is not clear that the cells are getting into the injury site at all when they are injected intrathecally.

    While there is some evidence that cerebrolysin may improve function in people with brain injuries, I don't think that there is any evidence that cerebrolysin is effective for spinal cord injury. Likewise, there are several phase 2 studies that suggest that fampridine improve function in people with chronic spinal cord injury but two phase 3 studies carried out in 2005-6 suggest that the drug does not improve spasticity.

    We just completed a phase 2 study of lithium treatment of chronic spinal cord injury. The study showed no effect of the 6-week course of lithium on motor or sensory function in people with chronic spinal cord injury at 6 weeks or 6 months. However, the study suggested that lithium may have some beneficial effects on neuropathic pain. This needs to be confirmed in a phase 3 trial specifically on patients with well-defined chronic neuropathic pain after spinal cord injury.

    ChinaSCINet and SCINetUSA are planning clinical trials to test combinations of umbilical cord blood cell transplants, lithium, and intensive rehabilitation in large multicenter clinical trials in China and the U.S. Umbilical cord blood has been reported by several groups to have beneficial effects when transplanted into the spinal cord. Lithium stimulates cord blood cells to grow and produce neurotrophins. It also stimulates neural stem cells to proliferate and differentiate into neurons.

    Several ongoing phase 2 trials of promising therapies are underway, particularly cethrin (Alseres) and nogo antibody (Novartis). Cethrin is a blocker of rho/rho kinase pathway that inhibits axonal growth. Phase 2 trials have already shown promising results. The nogo antibody likewise has shown promising results in phase 1 studies and is now in phase 2 studies.

    Several therapies should go to clinical trial. These include chondroitinase and decorin. The former has been reported by multiple laboratories to enhance regeneration in rats. A recent study suggested that a heat-resistant form of chondroitinase is particularly effective. Decorin is a molecule that Stephen Davies has reported to reduce chondroitin-6-sulfate proteoglycan accumulation at the injury site.

    In my opinion, the best therapies are combination therapies that include cell transplantation, growth factors, and blockers of growth inhibitors. This is the reason why we are testing umbilical cord blood cells and lithium, the first two parts of the combination of bridging the injury site and using lithium to increase neurotrophin secretion and stimulate axonal growth. If these therapies prove to be safe or effective, we will add growth inhibitor blockers.

    I don't want to give the impression that these combination therapies will be easy to test or that these therapies will be a slam-dunk. It will be a lot of work to get these therapies into trial and we don't know whether the combinations will be effective. However, animal studies suggest that these therapies will enhance regeneration and restore some function.

    Clinical trials have one other important benefit. They will show whether a therapy is effective or not. If a treatment is not effective, we go on the other treatments. *The worst thing is to keep applying therapies to people for decades, refusing the do the definitive trials to show whether the treatment is effective or not.

    Wise.

  2. #12

    Lithium and Neuropathic Pain

    Hello Wise,
    Could you tell me where I could find more information about the outcomes of the Phase 2 lithium treatment trial. I'm very interested in the comment you made regarding the possible beneficial effects on neuropathic pain. Are you saying that a phase 3 trial addressing this would be good of is it something that is planned and will be going ahead?

    Thanks in advance,
    Clayton

    Quote Originally Posted by Wise Young View Post

    We just completed a phase 2 study of lithium treatment of chronic spinal cord injury. The study showed no effect of the 6-week course of lithium on motor or sensory function in people with chronic spinal cord injury at 6 weeks or 6 months. However, the study suggested that lithium may have some beneficial effects on neuropathic pain. This needs to be confirmed in a phase 3 trial specifically on patients with well-defined chronic neuropathic pain after spinal cord injury.
    "Wheelie Wanna Walk!"

  3. #13
    Am I the only one confused.

    My daughter is 1 year post. I've been trying to get my head around all this.

    > Don't waste your money on getting stem cell injections now. Is it dangerous or just a waste of money? Could stem cell injections lead to cancer down the road?

    > Hanns Keirstead with high purity stem cells was successful in making rats walk. Looks like this is going to clinical trials next year in humans. Sounds very promising?

    1. For many people who had incomplete spinal cord injury (ASIA/ISCOS category B and C) and who never walked after spinal cord injury, intensive locomotor training can restore ability to walk without assistance in 70% or more.
    My daughter was labeled complete in the hospital. ASIA A complete at Kennedy Krieger at 4 months, incomplete by a doctor here at 6 months and incomplete ASIA B from a doctor at Shriners at around 8 months. The doctor at Shriners said ASIA B because she could feel inside her anus when doing her bowel program. The only one who did a complete exam was Kennedy Krieger. Should we be doing intensive locomotor training. Would riding a stationary cycle work?

    Sorry for jumping my thoughts around. I'm just trying to make sense from several posts and thought this would be a good place.

  4. #14
    Quote Originally Posted by Geoman View Post
    Hello Wise,
    Could you tell me where I could find more information about the outcomes of the Phase 2 lithium treatment trial. I'm very interested in the comment you made regarding the possible beneficial effects on neuropathic pain. Are you saying that a phase 3 trial addressing this would be good of is it something that is planned and will be going ahead?

    Thanks in advance,
    Clayton
    Clayton, I presented that information for the first time last week at a workshop for the ChinaSCINet group. We are in the process of writing up the results and also planning a further clinical trial to confirm. It did not reduce neuropathic pain in everybody. We will try to do the trial as quickly as possible, to confirm the results.

    Wise.

  5. #15
    Quote Originally Posted by gcblarsen View Post
    Am I the only one confused.

    My daughter is 1 year post. I've been trying to get my head around all this.

    > Don't waste your money on getting stem cell injections now. Is it dangerous or just a waste of money? Could stem cell injections lead to cancer down the road?

    > Hanns Keirstead with high purity stem cells was successful in making rats walk. Looks like this is going to clinical trials next year in humans. Sounds very promising?



    My daughter was labeled complete in the hospital. ASIA A complete at Kennedy Krieger at 4 months, incomplete by a doctor here at 6 months and incomplete ASIA B from a doctor at Shriners at around 8 months. The doctor at Shriners said ASIA B because she could feel inside her anus when doing her bowel program. The only one who did a complete exam was Kennedy Krieger. Should we be doing intensive locomotor training. Would riding a stationary cycle work?

    Sorry for jumping my thoughts around. I'm just trying to make sense from several posts and thought this would be a good place.
    gcblarsen,

    The data that was reported were adults and the ASIA classifications were done within the first week after injury. The extent to which the data would apply to your daughter and the relevance of ASIA classifications done more than a week after injury are not clear.

    On the other hand, I believe that locomotor training is something that your daughters should do. Because she is light, it should be relatively easy for her to do weight-supported walking (in a rolling walker) and being held by an adult. I would have her doing this at least an hour or more a day.

    Her youth is a positive factor in her favor. There is quite a lot of evidence to suggest that young cats will recover more function from locomotor training than adult cats. I believe that this is true of humans as well. The standing and walking is good for other aspects of her health.

    So, she has little to lose and much to gain by standing and walking several hours a day. We are now trying to figure out programs that can be applied in our clinical trial to children. As you know, we are planning to do the cord blood mononuclear cell and lithium trial at Shriners on kids from 8-17 years of age.

    Wise.

  6. #16
    Wise,
    That's great news. Thanks once again for your tireless effort.
    Clayton

    Quote Originally Posted by Wise Young View Post
    Clayton, I presented that information for the first time last week at a workshop for the ChinaSCINet group. We are in the process of writing up the results and also planning a further clinical trial to confirm. It did not reduce neuropathic pain in everybody. We will try to do the trial as quickly as possible, to confirm the results.

    Wise.
    "Wheelie Wanna Walk!"

  7. #17
    Dr. Young, thanks so much for the reply!

    On the other hand, I believe that locomotor training is something that your daughters should do. Because she is light, it should be relatively easy for her to do weight-supported walking (in a rolling walker) and being held by an adult. I would have her doing this at least an hour or more a day.
    I can't imagine 1 hour doing locomotor training each day. We don't have access to a lite gait. At therapy she does walk in her AFO and KAFO with a walker three times a week. All three sessions probably don't equal an hour. She also stands in a stander about thee times a week. We try an hour each time. She does more crawling than anything else. I'm hoping that counts some for locomotor training.

    One way that you can help is to get your friends in the spinal cord injury community to work together and start funding clinical trials. I know many people who have spent many thousands of dollars on unproven therapies in overseas clinics that have no interest or ability to show that the therapy is effective.
    I'm sure it is frustrating seeing those with SCI spend thousands on procedures that aren't proven. If I had money I wouldn't know the best use. I don't know if it would be a waste of money to give thousands to clinical trials that might not benefit my daughter. If I had money I would probably move to an area where my daughter could do intensive physical therapy as I feel confident that would help her now. The money I do have goes to medical bills and some therapy out of town.

    My heart goes out to those in China and elsewhere that don't have access and the care the deserve.

    I truly believe the methylprednisolone my daughter received is why she has the return she currenly has and wouldn't have received it if it wasn't for you. I just want to say that the work you do is very much appreciated! Thank you!

  8. #18
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    Quote Originally Posted by gcblarsen View Post
    Hanns Keirstead with high purity stem cells was successful in making rats walk. Looks like this is going to clinical trials next year in humans. Sounds very promising?
    Unfortunately, H. Keirstead does NOT plan to begin any clinical trials on chronic spinal cord injuries in 2010. They are still in the pre-clinical phase and don't have a timeline of when the data will be complete and submitted to the FDA. As you may know, the clinical trials can't begin until the full IND package is submitted and approved by the FDA.

    You’re going to need lots of patience since there is another trial which they're going to give themselves entirely to - type 1 infantile spinal muscular atrophy. However, two years would "probably" be a reasonable time. Please, not putting you down, just do your homework first. It is taking longer than I thought. I am sorry.
    2016

  9. #19
    Quote Originally Posted by Wise Young View Post
    On May 1, 2009, the Mininistry of Health of China issued new regulations that would take place in November 2009. These new regulations require all hospitals that provide cell transplantation treatments to be accredited and all cell transplant procedures to be approved. We were in the process of getting a clinical trial approved at the Kunming Army General Hospital and had all but obtained permission and a grant to do so when this ruling came out that we were told that we need approval from the Ministry of Health.

    We have now met senior officials of the Ministry of Health. One department head told us that our trial was not the responsibiity of his department and referred us to another. That department in turn said that it wasn't their responsibility and referred us to the sFDA (the state Food and Drug Administration). We wrote to the sFDA and just received a reply saying that this was the jurisdiction of the Ministry of Health. In short, nobody is making any decisions or taking responsibility for approving clinical trials involving cell transplants. I suspect that it may be many months before this bureaucratic issue is resolved. We have been trying to get permission to do the trial since last year.
    Dear Dr. Young,

    Sorry to bother you, but I wonder if there is any other obstacle than getting approval from Ministry of Health? If you get the approval, will further clinical trials carry out immediately?

    And, has Umbilical Cord Blood Mononuclear Cell been tested in previous trials? How about the result?

    Thank you in advance.
    It's a shame of human beings that SCI cannot be cured.

  10. #20
    Quote Originally Posted by suguo View Post
    Dear Dr. Young,

    Sorry to bother you, but I wonder if there is any other obstacle than getting approval from Ministry of Health? If you get the approval, will further clinical trials carry out immediately?

    And, has Umbilical Cord Blood Mononuclear Cell been tested in previous trials? How about the result?

    Thank you in advance.
    suguo,

    Umbilical cord blood treatments are being used by several groups to treat spinal cord ijnjury, including Beike Biotechnology. However, I don't think that any of the other groups are transplanting the cells into the spinal cord.

    Until the cell regulatory situation in the Ministry of Health in Beijing settles down, we are planning to carry out the phase 2 trial in Hong Kong, at the Chinese University of Hong Kong and the Univeristy of Hong Kong.

    Wise.

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