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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 wondering if the combination trials (lithium and HLA matched Umbilical Cord Blood Stem Cells) are still scheduled to begin in June of 2007 (only 5 months away)?

    Also, you previously indicated there are 20 participating SCINET centers. Do you have any idea how many different treatments will begin testing this year?

    Thanx

  2. #2
    We are still working out the regulatory, cell sourcing, and funding issues. At the present, I do not anticipate that we will be able to reach our goal of starting the combination cell transplant and lithium trial by June 2007. The combination trial is more likely to start in early 2008.

    Wise.

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    Senior Member KIM's Avatar
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    "I know Dr. Young would not agree, but getting something effective and beneficial to humans as quickly as possible should be the ultimate goal. The delay of even a single day of therapies to humans is unacceptable."

    Schmecky

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    Senior Member Schmeky's Avatar
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    Thanx for the update Dr. Young. I know you're doing everything that can be done. This is an enourmous undertaking.

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    Senior Member Rollin Rick's Avatar
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    I know this is an enormous task, but that really hurt. I'm sure most of us had our heart set on June, but I guess it's just like anything else, it always gets pushed forward. Another whole long year before anything gets started. This has just become a sad day.

    I know Dr. Young is doing everything he can for us, but I just cannot help to feel that a big brick has fallen. Sorry for rambling on, I'll feel better tomorrow. Hopefully the wiggling of toes will be in 2008.

  6. #6
    Dr. Young, thanks for the update. It's much better to be realistic and tell us what the status is now rather than wait until June.

    Can you give give us an update on the funding situation? While there is not much we can do for the most part this is an area where we actually could help.

  7. #7
    Banned Faye's Avatar
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    Quote Originally Posted by KIM
    "I know Dr. Young would not agree, but getting something effective and beneficial to humans as quickly as possible should be the ultimate goal. The delay of even a single day of therapies to humans is unacceptable."

    Schmecky
    Yeah, I remember the initial China SCInet called for the enrollment of 600 people in 2006.

    I guess that makes it a 2 year delay now.

    Maybe smaller is better after all.

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  8. #8
    wise -- those are tough words to breathe in as im sure they were for you to write. is it possible that you will know the results from the single lithium trial this year?are there any small satellite combination therapies going on in conjunction with ChinaSCI or similar infrastructure being created in United States without CRPA? thank you again for your ongoing hard work and be well!

    Faye, do you have any evidence of small trials that have shown successful restorative therapies? it is completely out of my area of expertise to know why a small study would be better than a large study -- or vice versa --I can only make guesses. but regardless, I'd be satisfied to see any sort of progress, whether it's minute or gargantuan as long as it is valid n peer-reviewed.
    Last edited by Chaz19; 01-28-2007 at 06:38 PM.

  9. #9
    Quote Originally Posted by litespeed4
    Dr. Young, thanks for the update. It's much better to be realistic and tell us what the status is now rather than wait until June.

    Can you give give us an update on the funding situation? While there is not much we can do for the most part this is an area where we actually could help.
    litespeed, thanks for the offer.

    Let me first comment on the setting of goals. I believe that one should adopt ambitious goals. The alternative is to set up conservative goals and people don't work as hard to achieve them. I know that it is disappointing to people when we do not achieve all of our original goals (as it is very disappointing to me as well) but it makes us work harder. By the way, we have achieved many of our original goals. All the centers are now using a single neurological standard and dataset for evaluating the therapies that they are testing (many are testing experimental therapies, as you know). Over half of the centers are now GCP qualified and we anticipate that the remainder will be qualified by the end of the year. The phase 1 lithium trial has started at Hong Kong University. We were recently told that the phase 2 lithium trial can be started in China within 2007. We are bringing 60 of the top Chinese spinal surgeons to Kunming next month to reach a consensus concerning the best way to transplant cells into human spinal cord.

    There are three major obstacles to getting the combination trial (CN103) going.

    The first is funding. I estimate that the combination trial will cost US$12 million (for clinical trial costs alone) and an additional US$12 million for estabishing GMP (Good Manufacturing Practice) cell processing faciities Over half of my time is dedicated to raising this money. To facilitate this effort, we have now created two non-profit companies. One is called China Spinal Cord Injury Network Inc. and the other is the charitable fundraising arm China Spinal Cord Injury Fund. We are working very hard to raise these funds.

    The second is the new clinical trial regulations in China. About two years ago, the sFDA (the Chinese equivalent of the US FDA) and the Ministry of Health (MoH) passed onerous new regulations that imposed very high standards on all clinical trials, higher than in the United States, for example. The requirements include getting GCP (Good Clinical Practice) certification not only of the hospital but of the department carrying out the clinical trial. Approval of clinical trials take a minimum of 9 months and often years, especially when there are no precedents for decisions. Our trial will be the first combination cell transplant and drug trial for spinal cord injury. We have been working closely with the leadership of both the MoH and sFDA for the past two years to achieve rapid approval. In fact, we just had very productive meetings with both agencies in Beijing.

    The third is turmoil in Chinese regulatory agencies. In 2004, the sFDA received over 10,000 new drug and product applications, and approved many of them. There have been charges of corruption and low standards. The former head of the sFDA and several of his colleagues, and his son, were fired and jailed recently. The leadership of the sFDA was changed recently. The premier of China called for a complete investigation and even re-evaluation of many of the drugs and clinical trials that have been approved. The current sFDA is embattled http://www.scidev.net/content/news/e...vestigation.cf but we were very surprised in a visit to them last week that they really want to help us.

    Wise.
    Last edited by Wise Young; 01-28-2007 at 09:20 PM.

  10. #10
    Banned adi chicago's Avatar
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    to rebuild a smashed strawberry is very hard.i hope that one day ...not me but others sci will walk and have a normal life again .me too ...why not?
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