Thread: ChinaSCINet Update

  1. #2381
    Dr. Young,

    My sister is Chronic complete ASIA A and in India. Please let me know whom to reach out, in case she can apply for the trial and if there is a place available.

    Regards,
    Neeraj Bansal

  2. #2382
    Najeer,

    Send me the email address you want me to add to our eBulletins list. This is the way we will disseminate info about all upcoming trials.

    jimbenn@rutgers.edu

  3. #2383
    Hi, does anyone know if Wise's paper has been published?

  4. #2384
    It has not yet.

  5. #2385
    Quote Originally Posted by Jim View Post
    It has not yet.
    Any idea when it will? Do you know why there has been a hold up?

  6. #2386
    Sorry to jump in late on this, but did I read they were having a hard time finding Asia A's? If so, I'm a C5/C6 Asia, or least that's what I've been told all along.

    Thanks.
    DaDutchman
    C5/C6 since 2007 due to car accident

  7. #2387
    Is their any treatment for Lumbar?

  8. #2388
    Quote Originally Posted by tompocket View Post
    Hi, does anyone know if Wise's paper has been published?
    tompocket, the paper has been submitted and is under review right now. We had submitted it to 4 other journals that returned it without review. If it is accepted, the paper should be published in March or April of 2016. Wise.

  9. #2389
    Quote Originally Posted by DaDutchman View Post
    Sorry to jump in late on this, but did I read they were having a hard time finding Asia A's? If so, I'm a C5/C6 Asia, or least that's what I've been told all along.

    Thanks.
    DaDutchman,

    We did have some trouble finding patients that were AIS A chronic in Hong Kong for our phase I trial. However, in China, this was not as much of a problem. So, in the upcoming Phase II trial that will be submitted to the U.S. Food and Drug Administration (FDA) and to the Drug Controller General of India (DCGI), we have decided to include patients who were initially AIS A and then converted to B or C. We call these severe stable spinal cord injury rather than complete spinal cord injury who are not walking. Note that most patients that are initially AIS B or C generally recover walking within a year. As soon as the FDA and the DCGI approve the protocol, we will of course announce the trial on www.clinicaltrials.gov and on this site, along with all the contact information. The participating centers will be the ones that choose people for the trial. Each of 3 centers in each country will choose 6 participants in the trial.

    The main reason for the delay is the long time it has taken for us to prepare the IND (the initial new drug/device) application to the US FDA and India's DCGI for the clinical trials. The document is extensive (over 1000 pages) and requires detailed information and tests concerning the manufacturing of the cells, the shipping, and the transplantation, as well as all the animal and safety studies. We have scheduled a pre-IND meeting with the US FDA in January and hope to submit the final application shortly after that meeting. Likewise, the clinical trial is being evaluated by the institutional review boards (IRB) in India and will be submitted to the DCGI as soon as the IRB applications have been approved. We will then work on the applications for the European Medicine Agency (EMA) and Norway as well as the China Food and Drug Administration (CFDA).

    Three other tasks must be accomplished before we can start the trials. The first is money of course. I have been spending a lot of time raising money for the trials. The fact that we are going forward with the US FDA and the DCGI applications indicate that we are confident that we have the funds of the trial in the U.S. and India. The second is the walking programs. We have also been spending a lot of time training the various centers to do the intensive locomotor training. The Kunming walking program is quite different from other programs around the world. Several years ago, I took groups of American and Norwegian doctors to Kunming to see the walking program. Last August, we have already taken a group of Indian doctors to the Kunming Tongren Hospital to see the walking program and surgery. The third is the cell processing. We will need to certify each hospital for their ability to handle the cells that will be shipped to them. This will require testing and validation of the hospitals. Before we did the trials in China, we tested over 100 units of umbilical cord blood to make sure that the transplanted cells are sterile, alive, and able to grow.

    The phase II trials that we are planning to carry out in India and the U.S. will transplant 6.4 million HLA-matched umbilical cord blood mononuclear cells (UCBMNC) into the spinal cords of all the patients and then randomize them to either a 6-week course of lithium carbonate or a 6-week course of lithium. The inclusion criteria are C5-T11, severe and stable SCI. The goals of the trial are to 1) to determine the feasibility of doing the 6-hours a day, 6-days a week, for 6 month walking training in these countries, 2) to determine that a 6-week course of lithium is beneficial when combined with UCBMNC transplants, and 3) to confirm the results from Kunming. In India, if the trial is successful, we hope that we will get conditional marketing approval so that the therapy will be available at cost to qualified doctors and their patients. In the U.S. and EMA, we hope that the FDA will grant compassionate use approval for the treatment for individual patients and qualified doctors.

    If the phase II trial show that lithium is not beneficial when combined with UCBMNC transplants, we will omit lithium from the phase III trial, which will compare UCBMNC transplants or no transplants. Of course, if lithium turns out to be beneficial when combined with UCBMNC transplants, the phase III trial will include lithium and compare surgery alone, surgery plus UCBMNC, surgery plus lithium, and surgery plus UCMBNC and lithium. As pointed out above, if the phase II trials confirm the efficacy of UCBMNC (>50% recovery of walking, bowel, and bladder function), we expect the DCGI to give conditional market approval and the U.S. FDA to approve compassionate use of UCBMNC transplants by qualified doctors and patients.

    Wise.
    Last edited by Wise Young; 12-15-2015 at 09:47 PM.

  10. #2390
    Quote Originally Posted by Wise Young View Post
    DaDutchman,

    We did have some trouble finding patients that were AIS A chronic in Hong Kong for our phase I trial. However, in China, this was not as much of a problem. So, in the upcoming Phase II trial that will be submitted to the U.S. Food and Drug Administration (FDA) and to the Drug Controller General of India (DCGI), we have decided to include patients who were initially AIS A and then converted to B or C. We call these severe stable spinal cord injury rather than complete spinal cord injury who are not walking. Note that most patients that are initially AIS B or C generally recover walking within a year. As soon as the FDA and the DCGI approve the protocol, we will of course announce the trial on www.clinicaltrials.gov and on this site, along with all the contact information. The participating centers will be the ones that choose people for the trial.

    The main reason for the delay is the long time it has taken for us to prepare the IND (the initial new drug/device) application to the US FDA and India's DCGI for the clinical trials. The document is extensive (over 1000 pages) and requires detailed information and tests concerning the manufacturing of the cells, the shipping, and the transplantation, as well as all the animal and safety studies. We have scheduled a pre-IND meeting with the US FDA in January and hope to submit the final application shortly after that meeting. Likewise, the clinical trial is being evaluated by the institutional review boards (IRB) in India and will be submitted to the DCGI as soon as the IRB applications have been approved. We will then work on the applications for the European Medicine Agency (EMA) and Norway as well as the China Food and Drug Administration (CFDA).

    Three other tasks must be accomplished before we can start the trials. The first is money of course. I have been spending a lot of time raising money for the trials. The fact that we are going forward with the US FDA and the DCGI applications indicate that we are confident that we have the funds of the trial in the U.S. and India. The second is the walking programs. We have also been spending a lot of time training the various centers to do the intensive locomotor training. The Kunming walking program is quite different from other programs around the world. Several years ago, I took groups of American and Norwegian doctors to Kunming to see the walking program. Last August, we have already taken a group of Indian doctors to the Kunming Tongren Hospital to see the walking program and surgery. The third is the cell processing. We will need to certify each hospital for their ability to handle the cells that will be shipped to them. This will require testing and validation of the hospitals. Before we did the trials in China, we tested over 100 units of umbilical cord blood to make sure that the transplanted cells are sterile, alive, and able to grow.

    The phase II trials that we are planning to carry out in India and the U.S. will transplant 6.4 million HLA-matched umbilical cord blood mononuclear cells (UCBMNC) into the spinal cords of all the patients and then randomize them to either a 6-week course of lithium carbonate or a 6-week course of lithium. The goals of the trial are to 1) to determine the feasibility of doing the 6-hours a day, 6-days a week, for 6 month walking training in these countries, 2) to determine that a 6-week course of lithium is beneficial when combined with UCBMNC transplants, and 3) to confirm the results from Kunming.

    Wise.





    Thanks a lot for the update Wise! Do you have a time frame for when the phase II will start? And how long will that trial likely run for? Or is it too early to say?

    Best of luck!

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