Thread: ChinaSCINet Update

  1. #2261
    Quote Originally Posted by ian View Post
    I would expect from a top SCi doctor that the news of a possible cure would definitely be in his field of interest. I said this years ago and I will repeat it now, no cure will come before publicity. Years ago half joking I advised Wise to try and get a spot on Oprah Winfrey as this is the only way the general public are going to get on board, without publicity there will be no cure.; I stand by this, there is no media publicity, if you cant sell something its pointless how effective it is. What is needed now is mass media publicity, this should be top priority. its not. No one knows about it, its a failure as far as anyone expecting a cure in their own country. of course my comments will be treated as unnecassary pessimisim and detracting from the "cure". Remember, 30 years and we have methyl pred which most doctors wont use anyway. Heard from the Miami project lately? How many millions of dollars , how many years wasted. I am pessimistic about the China SCi net not because I think the results are invalid but because its going no where. Wise doesnt like publicity but that is the downfall, if it cant be sold then its useless.
    Ian, please don't say this is a possible cure, it's not.

    It is a phase II safety study in small number of patients which showed significant results. The story here is in the data, but that can't be released until the the paper is published. When published, the media campaign will launch. In the meantime, we are preparing for phase III trials in China, India, Norway, and the U.S.

  2. #2262
    Senior Member ian's Avatar
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    What? Why is this posted in the Cure forum?

  3. #2263
    I think it is more accurate to say this therapy is returning function, rather than describing it as a cure. To me, cure means return to normal.

  4. #2264
    Senior Member lunasicc42's Avatar
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    whats the latest word on the path to publication ?
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  5. #2265
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    Quote Originally Posted by Jim View Post
    Ian, please don't say this is a possible cure, it's not.

    It is a phase II safety study in small number of patients which showed significant results. The story here is in the data, but that can't be released until the the paper is published. When published, the media campaign will launch. In the meantime, we are preparing for phase III trials in China, India, Norway, and the U.S.
    If it?s not too much to ask, could you please elaborate on what the phase III preparations are?

  6. #2266
    Senior Member khmorgan's Avatar
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    Quote Originally Posted by Jim View Post
    I think it is more accurate to say this therapy is returning function, rather than describing it as a cure. To me, cure means return to normal.
    I kind of agree with you Jim, but Dr. Young gave it far more thought than I have.

    See http://sci.rutgers.edu/forum/showthr...l=1#post106740

  7. #2267
    Jim or Dr wise
    Well all i can say on this topic a bout a cure ? is if i was to get my Dignity back i could walk with limp .


    It is a phase II safety study in small number of patients which showed significant results. The story here is in the data, but that can't be released until the the paper is published. When published, the media campaign will launch. In the meantime, we are preparing for phase III trials in China, India, Norway, and the U.S.

    If the FDA dose not let the paper to be published and is looking for more work on the safety end of things . Am i right this would be the first paper published of this kind . What is wrong with other countries FDA that would published it or dose it have to be in the US paper Would it not just be better doing all of the trials in China and let the people that can go there. with any luck the patience would come back with good results .There for the FDA would have past it and open the door for the rest of us


    I am sorry if this Question was ask be-four
    Last edited by skeaman; 12-24-2014 at 08:21 PM.
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  8. #2268
    Skeaman,

    I decided to combine the phase I and II studies in one report. That took a while to rewrite the manuscript because of the word limitations (3000 words) and because there was a lot of data from both trials to put into one paper. However, I felt that it was important to do this in order to emphasize the main conclusion of our study, i.e. no exercise no walk. If we did not present the Hong Kong data, where 8 subjects who received the transplants but no walking training did not walk. I have to get approval of all the investigators and people involved in the study (now up to 27).

    The paper now reports several very important findings. First, transplantation of umbilical cord blood mononuclear cells into the spinal cord is safe in 28 patients with chronic C5-T11 spinal cord injury, including one who turned out to be a C3 incomplete (ASIA C). None of the subjects lost neurological function. Second, a majority (15/20) of the subjects that received locomotor training recovered ability to walk at least 10 meters with minimal assistance in a rolling walker and 7 walk at least 10 meters without assistance. Third, a majority (12/20) regained sufficient bladder and bowel function so that they did not require any assistance for both functions and 11 subjects do not use catheters to empty the bladder compared to only 2 before treatment. In the previous manuscript, I could not talk about the Hong Kong results because that was in a separate manuscript. Reporting the two studies together makes for a much better paper. Of course, I had to obtain the approval of all the investigators.

    The delay in publication has nothing to do with the FDA. We closed the database in May 2014 and submitted the first version of the manuscript to a journal in August 2014. It was returned without review. We submitted to two other high-impact journals in September and October and they too return the manuscript without review. So, that was when I decided to combine the two manuscript and submit to a fourth high-impact journal in the hopes that the much improved report will receive a review.

    Journals return a manuscript without review when they think that the subject of the paper is too specialized or not suitable for their journal. Sometimes, they don't think that they have the appropriate reviewers. Other times, it may be because they don't think that the paper is good enough for their journal. The decision is made by the editors. The letters explaining their editorial decision all said that they thought the paper would be better submitted to a more specialized journal. So, we are submitting to a more specialized journal.

    In the meantime, we are working hard to getting the phase III trial organized and funded. I will address this in another post.

    Wise.





    Quote Originally Posted by skeaman View Post
    Jim or Dr wise
    Well all i can say on this topic a bout a cure ? is if i was to get my Dignity back i could walk with limp .


    It is a phase II safety study in small number of patients which showed significant results. The story here is in the data, but that can't be released until the the paper is published. When published, the media campaign will launch. In the meantime, we are preparing for phase III trials in China, India, Norway, and the U.S.

    If the FDA dose not let the paper to be published and is looking for more work on the safety end of things . Am i right this would be the first paper published of this kind . What is wrong with other countries FDA that would published it or dose it have to be in the US paper Would it not just be better doing all of the trials in China and let the people that can go there. with any luck the patience would come back with good results .There for the FDA would have past it and open the door for the rest of us


    I am sorry if this Question was ask be-four
    Last edited by Wise Young; 12-26-2014 at 10:07 PM.

  9. #2269
    Senior Member ian's Avatar
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    you are right, possible treatment. Nothing is a possible cure, I think the name of this forum should be changed and i will stop using the word cure. So should everyone else.

  10. #2270
    Quote Originally Posted by Leif View Post
    If it?s not too much to ask, could you please elaborate on what the phase III preparations are?
    Leif, how are you? I am sorry that I have been out of touch lately. I have been very busy and can report the following. First, Stemcyte has made a firm commitment to fund the phase III trial. They have retained a global CRO (clinical research organization) to help us apply for the clinical trials (IND) in all the countries. Second, we have started SCINetIndia. A fundraiser will be held probably in April or May. There is a group of families working to raise the money for the trial in India. Third, we have been working very hard on standardizing the rehabilitation (walking training) of the subjects. This, as you know, is the most difficult and worrisome aspect of the phase III clinical trials. Fourth, I have met with two companies that will be providing specialized functional electrical stimulation and sensory activation devices to facilitate recovery of voluntary motor function in the phase III trial. One company has agreed to supply the devices and the other company is interested and waiting for a formal proposal from us.

    I need to find a opening in my schedule to come to Norway with the CRO to see you and our doctor friends in Norway to get the trial application in. In am hoping that I can do this sometime in March or April.

    Wise.
    Last edited by Wise Young; 12-26-2014 at 10:01 PM.

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