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    Any new news ?
    www.adventuresofcolinandheather.blogspot.com !

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      I cannot give blow-by-blow updates of the trial. Kunming has transplanted 18 patients and Hong Kong has done 8. Nothing much is happening right now because of the combination of Christmas, New Year, and Chinese New Year. The trials will restart in February. Wise.

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        I heard he abandoned his research to pursue a career as a dance
        instructer. I sure hope it's not true.

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          Dr. Wise, I'd like to be a part of your trial.
          www.adventuresofcolinandheather.blogspot.com !

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            Originally posted by Colin83 View Post
            Dr. Wise, I'd like to be a part of your trial.
            Colin, we hope to start trials in the U.S. The trials have been delayed because we are hoping to get all the adverse events information from the current ChinaSCINet trials for our FDA applications. As soon as those trials have a start date, they will be announced her and also on http://clinicaltrials.gov, providing contact information and inclusion/exclusion criteria.

            Wise.

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              Dear Wise with what combination you will be going with your upcoming trial for lumbosacral injuries? Are you also thinking for chondroitinase to be included in ur coming trial?

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                Sorry if i missed this in an earlier post or thread
                Dr.Wise, at what point/time in your current trials will you be letting us know what progress has been made with your current patients. Will it be before the us trials start.
                c6 inc since 2-19-11
                ex pro-am motocross racer
                tilite aero z s2

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                  Originally posted by Wise Young View Post
                  Colin, we hope to start trials in the U.S. The trials have been delayed because we are hoping to get all the adverse events information from the current ChinaSCINet trials for our FDA applications. As soon as those trials have a start date, they will be announced her and also on http://clinicaltrials.gov, providing contact information and inclusion/exclusion criteria.

                  Wise.
                  Dear Wise why in this trials don't include penetration SCI such as gun-shoot, knife-cutting or SCI caused by non-traumatic condition?, thank you

                  Regards

                  Jose

                  Comment


                    Wise, I would like to add to this string of questions... Presumably the china trials are showing that the procedure is safe, so is there a reason that when the data is given to the US FDA you'd have to have the same inclusion criteria and couldn't move to C4,although safety has already been shown in china?
                    "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

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                      Originally posted by Wills77 View Post
                      Sorry if i missed this in an earlier post or thread
                      Dr.Wise, at what point/time in your current trials will you be letting us know what progress has been made with your current patients. Will it be before the us trials start.
                      ill 2nd this. i know that the very first HK patient is post 1 year of treatment.

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                        Originally posted by jcalix View Post
                        Dear Wise why in this trials don't include penetration SCI such as gun-shoot, knife-cutting or SCI caused by non-traumatic condition?, thank you

                        Regards

                        Jose
                        Jose,

                        In the current ChinaSCINet phase 2 trial, patients with gunshot and other penetrating wounds of the spinal cord are not being excluded. We do exclude patients who have lesions that extend more than 2 segments (this is because we are injecting into the injury edges and don't want to do a laminectomy that is wider that 3 segments). Depending on the results of the phase 2 trial, penetrating causes of spinal cord injury may or may not be excluded from the phase 3 trial.

                        Wise.

                        Comment


                          Originally posted by Jawaid View Post
                          Dear Wise with what combination you will be going with your upcoming trial for lumbosacral injuries? Are you also thinking for chondroitinase to be included in ur coming trial?
                          Originally posted by lunasicc42
                          Wise, I would like to add to this string of questions... Presumably the china trials are showing that the procedure is safe, so is there a reason that when the data is given to the US FDA you'd have to have the same inclusion criteria and couldn't move to C4,although safety has already been shown in china?
                          Jawaid and lunasicc42,

                          At the present, the lumbosacral studies are preclinical, i.e. being done in animals. I don't know enough yet to predict any therapeutic effect or plan. The data is not likely to be available for another year (or more). Chronic animal spinal cord injury experiments take a long time and a huge amount of work.

                          We are significantly behind our schedule for both the Hong Kong and Kunming trials. Of 40 planned subjects (20 in Hong Kong and 20 in Kunming), we have only 8 in Hong Kong and 18 in Kunming. Only several patients have reached their one year post-transplantation time and only two patients have received the highest dose with MP and lithium.

                          I met with the investigators and we have agreed on a plan to complete recruitment for the trial by the end of March. In Hong Kong, we are applying to regulatory authorities for permission to study only four more patients. If they agree, we will do transplant 2 patients in Kunming and 4 in Hong Kong by the end of March.

                          This unfortunately sets our schedule back. We will not be able to apply for an IND in the US until May or later. I had not anticipated that it would take so long to recruit patients for Hong Kong and that it would take us more than a year to get the import license for the cells into China. However, the trials themselves are going well. The investigators are collecting the data.

                          Wise.
                          Last edited by Wise Young; 21 Jan 2012, 6:58 AM.

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                            dear professor Young you said to going to make come patient of china has Hong-Kong for finish clinical trial in HK. and after madam poon said in a post would make for ten patient has Hong-Kong and ten the other one has kunming why to have still changed

                            sorry for all the questions but this is really interesting

                            thank you

                            Comment


                              Originally posted by Wise Young View Post
                              Jawaid and lunasicc42,

                              At the present, the lumbosacral studies are preclinical, i.e. being done in animals. I don't know enough yet to predict any therapeutic effect or plan. The data is not likely to be available for another year (or more). Chronic animal spinal cord injury experiments take a long time and a huge amount of work.

                              We are significantly behind our schedule for both the Hong Kong and Kunming trials. Of 40 planned subjects (20 in Hong Kong and 20 in Kunming), we have only 8 in Hong Kong and 18 in Kunming. Only several patients have reached their one year post-transplantation time and only two patients have received the highest dose with MP and lithium.

                              I met with the investigators and we have agreed on a plan to complete recruitment for the trial by the end of March. In Hong Kong, we are applying to regulatory authorities for permission to study only four more patients. If they agree, we will do transplant 2 patients in Kunming and 4 in Hong Kong by the end of March.

                              This unfortunately sets our schedule back. We will not be able to apply for an IND in the US until May or later. I had not anticipated that it would take so long to recruit patients for Hong Kong and that it would take us more than a year to get the import license for the cells into China. However, the trials themselves are going well. The investigators are collecting the data.

                              Wise.
                              stuff happens. we all know this very well. the good news is that the trial is still going on.
                              when do you expect to be able to share any data with us?

                              Comment


                                Barrington, the thing that stand out above everything else is: the trials in China have been delayed again. From Dr Young's update, it appears that lack of patients is the problem. Now, if we can't get enough patients in China, we're in trouble. At the very least we are in trouble with getting results in many of our lifetimes. The start of trials in the USA are out further and further, no matter who starts them. The Chase trials are only in discussion stages . The application and beging of phase 1 trials are years away. Stem Cell INc are in phase 1 trials in Switzerland. Wise Young's trials in China are dealyed. The beginning of trials in the USA were to begin in 1st quarteer of 2012. We have to be honest with ourselaves and the answer is quite clear. anthony

                                Anthony

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