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Thread: ChinaSCINet Update

  1. #621
    Senior Member muskie's Avatar
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    Hi Dr Young,

    We have been to your open house in Feb of this year and watched the webcast in March. We plan on being there in April. Could you please take a look at the questions below presented to me in another forum.

    1. Were any large animal studies completed to show proof of efficacy?
    2. At what point will controls be finally added to the trial to show that the recovery isn't solely from the intense 6/6/6 rehabilitation as opposed to any cell treatment?
    3. Has anyone lost function during your latest trial?
    4. If a candidate was accepted in your Phase 3 trial, would they still be eligible for others in the future if you've been injected with cord cells and a psychotropic drug?
    5. Has the glia scar problem from macrophages been addressed or dissolved with Chondroitinase prior to inserting the cells? How will any new axonal growth penetrate the scar and make appropriate synapses?

    Thanks,

    Muskie

  2. #622
    Muskie, great questions
    thank you

  3. #623
    Senior Member khmorgan's Avatar
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    Quote Originally Posted by muskie View Post
    Hi Dr Young,

    We have been to your open house in Feb of this year and watched the webcast in March. We plan on being there in April. Could you please take a look at the questions below presented to me in another forum.

    1. Were any large animal studies completed to show proof of efficacy?
    2. At what point will controls be finally added to the trial to show that the recovery isn't solely from the intense 6/6/6 rehabilitation as opposed to any cell treatment?
    3. Has anyone lost function during your latest trial?
    4. If a candidate was accepted in your Phase 3 trial, would they still be eligible for others in the future if you've been injected with cord cells and a psychotropic drug?
    5. Has the glia scar problem from macrophages been addressed or dissolved with Chondroitinase prior to inserting the cells? How will any new axonal growth penetrate the scar and make appropriate synapses?

    Thanks,

    Muskie
    I'm sure Dr. Young will respond when he has time, until then some background reading obtained by Googling this forum:

    1. http://sci.rutgers.edu/forum/showpos...8&postcount=27
    http://sci.rutgers.edu/forum/showpos...4&postcount=31

    2. http://sci.rutgers.edu/forum/showpos...76&postcount=2

    3. http://sci.rutgers.edu/forum/showpos...&postcount=563

    I'll leave it to you to Google for information on 4 and 5.

  4. #624
    Quote Originally Posted by muskie View Post
    Hi Dr Young,

    We have been to your open house in Feb of this year and watched the webcast in March. We plan on being there in April. Could you please take a look at the questions below presented to me in another forum.

    1. Were any large animal studies completed to show proof of efficacy?
    2. At what point will controls be finally added to the trial to show that the recovery isn't solely from the intense 6/6/6 rehabilitation as opposed to any cell treatment?
    3. Has anyone lost function during your latest trial?
    4. If a candidate was accepted in your Phase 3 trial, would they still be eligible for others in the future if you've been injected with cord cells and a psychotropic drug?
    5. Has the glia scar problem from macrophages been addressed or dissolved with Chondroitinase prior to inserting the cells? How will any new axonal growth penetrate the scar and make appropriate synapses?
    Thanks, Muskie
    Hi Muskie,

    Dr. Young is traveling, not sure when he will see this. Thanks for the links khmorgan, I'll add what I know.

    3. No patients have lost any function.

    4. Those who take part in these trials will be eligible to be in future trials of ChinaSCINet/SCINetUSA. In this trial, Lithium is taken orally.

    5. Dr. Young addressed the issue of a "scar", here- http://sci.rutgers.edu/forum/showthread.php?t=136656

  5. #625
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    Man-Jung Hung will be presenting from Taiwan for stem cell therapy for urinary incontience and pelvic floor dysfunction at 8th Asia pacific symposium on neural regeneration.

    I dont understand from pelvic floor dysfunction? Is it about sexual function and bladder bowel or something else?

    I hope Wise will listen to him and give feedback after symposium.

  6. #626
    Quote Originally Posted by muskie View Post
    Hi Dr Young,

    We have been to your open house in Feb of this year and watched the webcast in March. We plan on being there in April. Could you please take a look at the questions below presented to me in another forum.

    1. Were any large animal studies completed to show proof of efficacy?
    2. At what point will controls be finally added to the trial to show that the recovery isn't solely from the intense 6/6/6 rehabilitation as opposed to any cell treatment?
    3. Has anyone lost function during your latest trial?
    4. If a candidate was accepted in your Phase 3 trial, would they still be eligible for others in the future if you've been injected with cord cells and a psychotropic drug?
    5. Has the glia scar problem from macrophages been addressed or dissolved with Chondroitinase prior to inserting the cells? How will any new axonal growth penetrate the scar and make appropriate synapses?

    Thanks,

    Muskie
    Muskie,

    Thank you for your questions.

    1. No large animal studies have been done to show efficacy of the combination of umbilical cord blood mononuclear cells and lithium. However, umbilical cord blood cells transplants have been reported to improve recovery of function in dogs, as well as rodents. Lithium has been reported in two independent studies to stimulate regeneration in rats. Note that large animal studies are required for safety and not for efficacy. In the case of umbilical cord blood, these cells have been transplanted to replace bone marrow in many thousands of people for cancer and hematopoietic disorders. Cord blood cells have been transplanted into people. In the case of lithium, millions of people have taken lithium for manic depression and other conditions.

    2. We are currently doing escalating dosing trials of umbilical cord blood mononuclear cells and one of the groups will be combined with a 6-week course of oral lithium. The doses are being compared with each other to see which dose safe and produces the best improvement of function. If these studies shows safety and a trend towards efficacy, we will proceed to phase 3 multicenter trials where we will be comparing umbilical cord blood cells with placebo and umbilical cord blood cells in combination with lithium. If neither groups show any improvement compared to pre-treatment, we will conclude that the therapy is ineffective and recommend against the use of the cells. If both groups show significant improvements compared to pre-treatment status, it would suggest that that umbilical cord blood alone is beneficial and lithium does not have beneficial effects. If umbilical cord blood cells plus lithium is effective but cord blood cells alone are not, then this would strongly argue for efficacy of the combination therapy.

    3. We are still doing the followup studies in our phase 2 trials assessing escalating doses of umbilical cord blood cell transplants and lithium. It is too early to conclude that the treatment is safe. One subject had transient loss of sensory function but recovered. Several subjects have had transient or variable increases in neuropathic pain. We cannot and should not be concluding anything about safety of the therapy until all the data is in. To date, the transplants appear to be safe in the short term.

    4. If a person has participated in one of our current trials or future trials, whether that person would be eligible for other trials depend on those other trials. While I cannot guarantee what other trials will stipulate in their entry criteria, we (ChinaSCINet, SCINetUSA, SCINorway, and SCINetIndia) will be planning clinical trials for people who have participated in previous clinical trials.

    5. I have addressed the subject of "glial" scar many times on these forums. I don't think that there is convincing evidence that glial scars represent a significant obstacle to axonal regeneration. I have publicly said that I do not agree with the terminology of glial scar and that I do not believe that glial scars represent a significant obstacle to regeneration in contused spinal cords. Scientists who claim to have shown that such scars prevent regeneration use models of spinal cord injury that cut or make other penetrating wounds of the spinal cord, allowing fibroblasts to move into the injury site. In the vast majority of people with spinal cord injury, the spinal cord is not cut and the dura is intact. Furthermore, many scientists have shown that the spinal cord regenerate in the presence of glial scars, associated with penetrating wounds where fibroblasts have invaded into the injury site. For example, Kai Liu recently showed that knocking out or inhibiting PTEN in cortical neurons stimulated regeneration of many axons in transected and hemisected spinal cords even though nothing was done to rid the spinal cord of glial scars at the transection/hemisection sites. We are considering adding chondroitinase to the combination but phase 1 and 2 trials need to be done with chondroitinase before we can add it to combination therapies.

    Wise.
    Last edited by Wise Young; 03-23-2012 at 01:06 PM.

  7. #627
    Senior Member muskie's Avatar
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    Thanks Doc, I am probably over my head but am stubborn enough to keep trying to learn. When your phase 3 trials come to the US where will the surgeries be preformed? I know some of the places you stated are hospitals but what about someplace like Kessler?

    Muskie

  8. #628
    Senior Member lunasicc42's Avatar
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    Am pretty sure one is austin, texas
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  9. #629
    Senior Member muskie's Avatar
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    Brakenridge? I think and that was a phase 2 clinical, not sure if that was on the list for phase 3

  10. #630
    Quote Originally Posted by muskie View Post
    Brakenridge? I think and that was a phase 2 clinical, not sure if that was on the list for phase 3
    University Medical Center Brackenridge - Seton

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