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    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

    Comment


      Is their any treatment for Lumbar?

      Comment


        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.

        Comment


          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; 15 Dec 2015, 9:47 PM.

          Comment


            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!

            Comment


              Patients from other countries can enroll?

              Hi,

              I saw that you had trouble in finding patients AIS A chronic. My brother is AIS A chronic but we live in Romania.
              Can he participate in your trials? Are there foreign patients accepted?

              Thanks,
              Robert.

              [QUOTE=Wise Young;1786561]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.

              Comment


                Wise,
                What are the centers in the U.S. that will be carrying out your trial?

                Comment


                  Hi Dr. Young and Jim,
                  Checking in and can't help but be disappointed that 2015 is drawing to a close and your paper is still not published. Clinical trials not started in the US or internationally. Can you give us an update? When can we expect to review your results in an internationally recognized scientific publication? When can we expect clinical trials in the US to begin? I understand that trials depend upon financing, but I cannot understand the continued delay in publication.

                  Really hoping that 2016 will bring significant advancements in the recovery of chronic spinal cord injured.

                  beachlover

                  Comment


                    Originally posted by Wise Young View Post
                    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.
                    Wise, I think I speak for everyone here when I say I appreciate your honesty about your paper's submission history. Cheers.

                    To follow up, can you tell us which journals returned your paper? Did any of the returned papers come with any explanation of the return?

                    Finally, are you at all concerned that four journals rejected what appears (from 10,000 feet away) like a groundbreaking project on a poorly researched topic?

                    I look forward to your response.

                    Much thanks,

                    Kyle

                    Comment


                      Originally posted by cripwalk View Post
                      Wise, I think I speak for everyone here when I say I appreciate your honesty about your paper's submission history. Cheers.

                      To follow up, can you tell us which journals returned your paper? Did any of the returned papers come with any explanation of the return?

                      Finally, are you at all concerned that four journals rejected what appears (from 10,000 feet away) like a groundbreaking project on a poorly researched topic?

                      I look forward to your response.

                      Much thanks,

                      Kyle
                      This.

                      If I remember correctly, they returned it because it was too "specialised." But really, FOUR rejections?

                      Comment


                        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. Each of 3 centers in each country will choose 6 participants in the trial.
                        Wise,

                        Thank you for your response. I apologize for not checking earlier to see if there was a response.

                        At this point, my course of action would be to register at the site www.clinicaltrials.gov. If this is incorrect, please let me know. Also, and I believe someone has asked this same question, what are the 3 centers for the US?

                        Once again thank you very much for your time and efforts. May the year 2016 bring about many fruitful and meaningful results.

                        Sincerely
                        DaDutchman
                        C5/C6 since 2007 due to car accident

                        Comment


                          DaD, when there is news about the upcoming clinical trials we will send out a blast email. If you want to receive, email me at jimbenn@rutgers.edu.

                          Comment


                            Thanks for the feedback Jim. Please look for an e-mail from me.

                            DaDutchman
                            DaDutchman
                            C5/C6 since 2007 due to car accident

                            Comment


                              I'm curious about the original P-I & II patients who participated several years ago that had gained some recovery doing 666's n'all... any updates/anything else new in regards of their progress/recovery that can be shared here?
                              "Talk without the support of action means nothing..."
                              ― DaShanne Stokes

                              ***Unite(D) to Fight Paralyses***

                              Comment


                                Last I heard, they are planning to bring the patients back to examine.

                                Comment

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