Thread: ChinaSCINet Update

  1. #2521
    Quote Originally Posted by scimike View Post
    I see your point but the point is made that FDA is blocking so many things. I just disagree and I do not trust politicians to make such decisions. Politicians should appoint qualified people to make a judgement and congress should not vote up or down on health issues. This is not the right topic for this thread.
    The decisions have already been made by medical professionals a.k.a. qualified people, and the device, procedure, etc., has been in use in many cases for years in other countries and have shown to be safe. There is no medical reason they shouldn't be approved in the U.S. The senator is simply saying that the FDA needs to act on it or Congress will. And yes it IS relevant to this thread considering that Dr. Young and his colleagues have spent the last two YEARS carefully compiling data on their results that they obtained in Phase I and Phase II human trials and getting that data published in a reputable medical journal. And now the FDA wants more animal studies? For what?? The rats in China are no different that the rats in the USA and the results won't be any different either. And then what will the FDA decide that they need more of? And how long are you willing to wait on the FDA? It is obvious that ultimately our fate does not lie in the hands of the doctors and researchers but rather in the hands of a bureaucrat. And that is pretty damn depressing.


  2. #2522
    Quote Originally Posted by tumbleweeds View Post
    Dr. Young and his colleagues have spent the last two YEARS carefully compiling data on their results that they obtained in Phase I and Phase II human trials and getting that data published in a reputable medical journal. And now the FDA wants more animal studies? For what?? The rats in China are no different that the rats in the USA and the results won't be any different either. And then what will the FDA decide that they need more of? And how long are you willing to wait on the FDA? It is obvious that ultimately our fate does not lie in the hands of the doctors and researchers but rather in the hands of a bureaucrat. And that is pretty damn depressing.
    In the ChinaSCINet Phase II & IIb, a total of 28 humans received escalating doses of Umbilical Cord Blood Cells. Not one lost function, mich was gained. The paper is coming out in Cell Transplantation this month or next and will be open access to all.

  3. #2523
    Senior Member lunasicc42's Avatar
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    What exactly is going on with wise and chinascinet? He hasn't given an update in ages...I just chalked it up to "he is just working very hard and is too busy to come around" but it's been Highly unusually long since wise himself has chimed in
    "That's not smog! It's SMUG!! " - randy marsh, southpark

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  4. #2524
    Update on ChinaSCINet

    I apologize for not having posted an update for a long time. The reason is that we don?t have any specific announcements of trials starting. While the paper has been accepted for publication since March 2016, it has not yet appeared in print. The original submitted manuscript can be downloaded http://www.ingentaconnect.com/search...ize=10&index=7

    Second, we have been working very hard on get Phase IIb clinical trials going in the U.S., China, Taiwan, and India. Our trial in Kunming showed a clear dose-response curve with better walking recovery in patients with higher doses. At the highest 6.4 million cell dose, all four patients recovered walking. However, 4 patients that received the 6.4 million cell dose plus methylprednisolone did not walk as well and 3 patients that received the 6.4 million cell dose plus methylprednisolone and a 6-week course of lithium did not show any improvement in walking. For this reason, we have to do a phase IIb trials before starting phase III trials, to determine whether lithium is beneficial or not, when combined with umbilical cord blood mononuclear cell (UCBMNC) transplants. If it is not beneficial, we would not include it in the phase III trial.

    Third, we met with the US FDA in January 2016 and they thought that our trial application was reasonable but they required us to do additional animal studies to ensure that the cells will not form tumors and also will not escape from the spinal cord. These studies are now underway and we should have all of the data by May 2017, at which time we should have approval of the clinical trial. We will be doing the trial in New Jersey and New York.

    Fourth, in India, with the support of Apollo Hospital, we have been able to organize a trial that hopefully will start in the first quarter of 2017. We will do the trial at Apollo Hospital in Chennai, Ambani Hospital in Mumbai, and the LTMG Hospital in Mumbai. There is quite a lot of support at the very top of the government and many of the doctors are every enthusiastic about doing the trial. We hope that the trial will be approved quickly by the DCGI (Drug Controller General of India).

    Fifth, in China, we have met some obstacles. Two years ago, we were told that the cells must be processed in China. We therefore identified several hospitals and taught them how to transplant the cells. However, the rules have changed. They now say that the umbilical cord blood cells must come from China. So, we have to find a partner in China that has a large umbilical cord blood public bank.

    Sixth, in the meantime, Taiwan has expressed a strong interest in doing the trial. We are currently in discussion with the National Taiwan University, Taipei Medical University, and the Buddhist Tzu Chi Hospital to do the trial. There is quite a lot of excitement and the Tzu Chi Hospital has indicated that interest and willingness to do all the walking training of the patients.

    Seventh, I have been doing everything possible to help Stemcyte raise the funds for the trials. It is probably going to end up costing about $5 million for the phase IIb trials and $15 million for the phase III trials. So, the company will have to do an initial public offering (IPO) to raise about $30 million to pay for this.

    Finally, we have been working very hard to scale the production of mononuclear cells so that we can treat hundreds of thousands of patients. At the present, the processing of the cells is very expensive and inefficient. We can only treat about 700 patients a year. We anticipate that when the treatment is approved in 2019 or 2020, we will need to have enough cells to treat 300,000 people a year. At the present, there are only 600,000 umbilical cord blood units stored around the world. In 2 years, we would deplete the entire world supply of umbilical cord blood.
    Last edited by Jim; 02-18-2017 at 05:54 PM. Reason: fixed URL

  5. #2525
    Senior Member lunasicc42's Avatar
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    hello man!
    "That's not smog! It's SMUG!! " - randy marsh, southpark

    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


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  6. #2526
    Senior Member lunasicc42's Avatar
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    please touch on your thoughts about what benefit and when a person with a c456 injury could Possibly expect from this avenue
    "That's not smog! It's SMUG!! " - randy marsh, southpark

    "what???? , you don't 'all' wear a poop sac?.... DAMNIT BONNIE, YOU LIED TO ME ABOUT THE POOP SAC!!!! "


    2010 SCINet Clinical Trial Support Squad Member
    Please join me and donate a dollar a day at http://justadollarplease.org and copy and paste this message to the bottom of your signature

  7. #2527
    Thanks for the update, obviously everyone is rooting for this to be a success. Many thanks for the hope.

    If it all works out and the treatment is approved the following seems vital to me:

    Quote Originally Posted by Wise Young View Post
    Finally, we have been working very hard to scale the production of mononuclear cells so that we can treat hundreds of thousands of patients. At the present, the processing of the cells is very expensive and inefficient. We can only treat about 700 patients a year. We anticipate that when the treatment is approved in 2019 or 2020, we will need to have enough cells to treat 300,000 people a year. At the present, there are only 600,000 umbilical cord blood units stored around the world. In 2 years, we would deplete the entire world supply of umbilical cord blood.
    Some questions if I may,

    1) When you say inefficient, do you mean that if you manage to improve the process then you would be able to treat more than 1 person with a single unit? Or do you mean inefficient as it takes a long time and costs a lot of money, I know you said expensive already but did you mean expensive as well as inefficient?

    2) If you aren't going to be able to make the cells go further then what needs to happen to have more umbilical cord blood units? I can't work out from Stemcytes web site how they get the blood, apart from people storing their own (which I suppose wouldn't be usable for this anyway). Do you envisage that hospitals would start asking parents to donate the blood at birth time? (I'm thinking you would need 0.25% of people to say yes to get your 300,000 a year).

    thanks again,

  8. #2528
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    Wise will you start lumbosacral trials after this trial? Should i guess lumbosacral trials still few years away

  9. #2529
    Quote Originally Posted by Jawaid View Post
    Wise will you start lumbosacral trials after this trial? Should i guess lumbosacral trials still few years away
    Jawaid, we do not yet have a therapy that works in animal models yet. We are working on it. Wise.

  10. #2530
    Quote Originally Posted by niallel View Post
    Thanks for the update, obviously everyone is rooting for this to be a success. Many thanks for the hope.

    If it all works out and the treatment is approved the following seems vital to me:



    Some questions if I may,

    1) When you say inefficient, do you mean that if you manage to improve the process then you would be able to treat more than 1 person with a single unit? Or do you mean inefficient as it takes a long time and costs a lot of money, I know you said expensive already but did you mean expensive as well as inefficient?

    2) If you aren't going to be able to make the cells go further then what needs to happen to have more umbilical cord blood units? I can't work out from Stemcytes web site how they get the blood, apart from people storing their own (which I suppose wouldn't be usable for this anyway). Do you envisage that hospitals would start asking parents to donate the blood at birth time? (I'm thinking you would need 0.25% of people to say yes to get your 300,000 a year).

    thanks again,
    We are improving the efficiency and lowering cost not only by automating processing so that several units can be processed per hour by one person but we are trying to get multiple doses of mononuclear cells per unit of cord blood. Nevertheless, it is still very expensive to collect and process 32,000 umbilical cord blood units, which is the size of the library that I estimate is needed to match human leukocyte antigens (HLA ≥4:6) for 95% of people. So, we are developing other approaches to help defray the costs of collection, processing, and storage to less than $2000/unit.

    Wise.

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