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Thread: ChinaSCINET on Schedule?

  1. #1
    Senior Member Schmeky's Avatar
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    ChinaSCINET on Schedule?

    Dr. Young,

    Just curious, is the next phase of HLA matched UBSC's and Lithium on schedule for the first quarter of 2008?

    If so, do you have an anticipated start date for the next series of trials? As an aside, I have not taken the time lately to thank you for the tirelesss work you have done to advance treatments for SCI. You're effort is truly Hurculean.

    Thank You.

  2. #2
    Quote Originally Posted by Schmeky
    Dr. Young,

    Just curious, is the next phase of HLA matched UBSC's and Lithium on schedule for the first quarter of 2008?

    If so, do you have an anticipated start date for the next series of trials? As an aside, I have not taken the time lately to thank you for the tirelesss work you have done to advance treatments for SCI. You're effort is truly Hurculean.

    Thank You.
    Schmeky,

    As I think that I have mentioned before, the lithium phase 1 trial finished before Christmas. A preliminary survey of the data suggests that the treatment is safe. The data is now undergoing complete checking and analysis (by the Clinical Trial Centre at Hong Kong University). I am hoping that we will have the completed analysis by early February.

    The phase 2 lithium trial should start shortly after the Chinese New Year (after the 7th of February). All the agreements are in place although we are still doing some final negotiations on the insurance for the trial. The drug and placebo have been prepared. We are initiating the final trial preparations.

    One of our centers, the Kunming Army General Hospital just completed a detailed study of intramedullary spinal cord decompression in thirty patients with acute spinal cord injury. This study documented the safety and even benefit of opening the dura and untethering the spinal cord, even during the first few weeks after spinal cord injury. This study provides us with convincing evidence that it is safe to expose the spinal cord for cell transplantations. We have submitted study this for publication. In some ways, it is like a phase 1 surgery trial.

    The phase 2 cord blood trial preparation is going well except for one problem. We discovered viability of human cord blood mononuclear cells is low when the cells were thawed, separated, and frozen again on the same day. My staff has been working hard to solve the problem. We have developed and are testing several workarounds.

    The training of all the centers for the phase 3 are proceeding well. In December 2007k we held a workshop in Fuzhou where we re-trained all the clinicians to carry out the ASIA examination and added two additional outcome measures to our repertoire: the WISCI and the SCIM. The WISCI is a walking score and SCIM is a function core. We are planning another workshop in Xi'an in May.

    The GCP certification of our centers is also going well. We anticipate that at least 15 of our centers will receive GCP (Good Clinical Practice) certification from the sFDA before the summer and will be ready to participate in the phase 3 trial. This is a requirement for the centers to be part of the phase 3. Not only the hospital but the specific department must receive the certification to carry out orthopedic clinical trials (the category under which spinal cord injury is classified in China).

    The CN100 extension study is going as planned. About 15 of our 25 centers have now completed the riginal CN100 observation study, with about 358 subjects with SCI followed for a year. Ten centers that have joined us since January 2006 are starting a shortened 6-month CN100e (extension) study, each adding another 20 SCI patients. We anticipate that we will have over 600 patients recruited for the phase 3 study by the end of 2008.

    The fundraising is proceeding. On February 2, TVB (one of the two major TV channels in Hong Kong) will host a fundraiser in prime-time. We are hoping to raise the funds to cover the phase 3 and we have been working hard on both corporate and the private donors. Altogether, I am anticipating that the combined ChinaSCINet trials through phase 3 will cost about US$20 million.

    As far as trials in the United States are concerned, I was hoping that the passage of the $450 million New Jersey stem cell bond will provide some funding for initiating similar trials here in the U.S. As you know, this did not turn out and the bone was voted down by New Jersey voters on November 6. We are working hard to get it on the ballot in this coming November. In the meantime, we am trying to raise the funds to make sure that we win this round.

    Wise.
    Last edited by Wise Young; 01-21-2008 at 02:12 PM.

  3. #3
    expensive wise Young Ci phase II shows that lithium alone and not effective will continue yourself with lithium?

    guerdener

  4. #4
    Quote Originally Posted by fti
    expensive wise Young Ci phase II shows that lithium alone and not effective will continue yourself with lithium?

    guerdener
    Dear fti,

    Our phase 1 lithium study had no control and was intended to help us determine the best way to titrate lithium and to show that it is feasible and safe. Our upcoming phase 2 may allow us to determine the extent to which it improves neurological function or problems.

    Our eventual goal is to test lithium's effect on mononuclear cell transplants.

    Wise.

  5. #5
    do cases what I want to say and who phase II and to prove effectiveness only of lithium? Ci lithium and not effective in phase II how to only go to phase III?

    guerdener

  6. #6
    Quote Originally Posted by fti
    do cases what I want to say and who phase II and to prove effectiveness only of lithium? Ci lithium and not effective in phase II how to only go to phase III?

    guerdener
    guerdener, may I request that you include French in your statements. I don't understand your English and can only guess at what you are asking.

    When one does combination therapies, it is essentialy that one establishes the safety and possible efficacy of the individual therapies before combining them. That is what we are doing, systematically and carefully.

    Wise.

  7. #7
    Moderator kate's Avatar
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    Thanks so much Wise

    For everything. SCI is no match for you.

  8. #8
    ce que je veux dire ces que pour que le lithium va a la phase III il faux quille prouve son efficacité seul et dans les études pré-clinique il disse que le lithium seul et pas efficace ? http://www.ncbi.nlm.nih.gov/pubmed/1...ubmed_RVDocSum

    what do I want to say these that so that lithium goes to phase III it false keel its effectiveness proves only and in the studies pre-private clinic it said that lithium alone and not effective?

    GUERDENER

  9. #9
    Quote Originally Posted by fti
    ce que je veux dire ces que pour que le lithium va a la phase III il faux quille prouve son efficacité seul et dans les études pré-clinique il disse que le lithium seul et pas efficace ? http://www.ncbi.nlm.nih.gov/pubmed/1...ubmed_RVDocSum

    what do I want to say these that so that lithium goes to phase III it false keel its effectiveness proves only and in the studies pre-private clinic it said that lithium alone and not effective?

    GUERDENER
    That study is on a hemisection model of spinal cord injury and it only tested one dose and one duration of the drug, based on very limited behavioral testing. We have to determine whether lithium alone does anything in human. It needs to be done. We are not testing lithium alone in the phase 3.

    Wise.

  10. #10
    mais ci le lithium seul ou un autre médicament et pas efficaces dans une phase II il peux aller a la phase III ?


    But this the only lithium or another medicine and not effective in a phase II he(it) can go has the phase III?


    merci beaucoup pour vos réponse

    guerdener

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