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    Originally posted by ay2012 View Post
    Dr. Young,
    Whenever you have some time, was there anything of note that came from the investigators meeting in Xian? In particular, anything about the manuscript for the paper on the Phase I/II trial? Trial design/regulatory approval/funding/timeline for starting the Phase III in China? Future trials and therapies?) I think everyone here is interested in whether or not the animal studies using Cethrin have gotten going.) Thanks as always.
    I just finished the meetings in Xi'an. It went very well. We are on our way to India for an investigator meeting there. If there is anything significant to report, I will post here.

    Wise.

    Comment


      I just removed a large number of posts to Discussion from ChinaSCINet Update in Members only because the posts were clogging up this topic which is reserved for reporting and discussing progress in the ChinaSCINet trials.

      if you have questions about the ChinaSCINet trials, please ask. However, please refrain from posting irrelevant comments about other trials or questions about spinal cord injury mechanisms on this topic. I started this topic to inform people about the progress in the ChinaSCINet trials. Questions about other trials and arguments with each other are interfering with communication about progress in the ChinaSCiNet trials. Thank you.

      Wise.
      Last edited by Wise Young; 16 Apr 2013, 1:51 PM.

      Comment


        Wise, you didn't quite answer Wills77 about your trials. Info I received in the mail about them say that they're focusing on those with chronic, complete sci injuries and says nothing about those with chronic, incomplete sci injuries or when/if incomplete injuries will be benefited by these trials. I'm pretty disappointed. There are more people with incomplete sci injuries, aren't there? And aren't they more likely to respond to your therapy since it also involves walking? They should be in the trials first or parallel to them, it seems to me. What do you think? Thanks...

        Jan

        Comment


          Originally posted by FellowHawkeye View Post
          Wise, you didn't quite answer Wills77 about your trials. Info I received in the mail about them say that they're focusing on those with chronic, complete sci injuries and says nothing about those with chronic, incomplete sci injuries or when/if incomplete injuries will be benefited by these trials. I'm pretty disappointed. There are more people with incomplete sci injuries, aren't there? And aren't they more likely to respond to your therapy since it also involves walking? They should be in the trials first or parallel to them, it seems to me. What do you think? Thanks...

          Jan
          It has nothing to do with how many incompletes and how many completes are out there. Complete injurys just have a lot more significance on possible benefical effects of a treatment then incompletes.

          Comment


            This may be unrelated to this thread but I have read in several places that the Chinese government is dumping billions into medical research. anywhere from 20 to 60% growth. I'm curious if any of this has helped with the finacial burden with SCI research including your own in China? And on the flip side the US cuts here in the US :/
            T6 complete since 3/21/2012

            Comment


              Dr. wise young,

              I see you are doing phase 111 trials for asia a complete injuries how can I participate in the trials?

              Comment


                Dr Young. Have you or have you ever thought off video taping the patient before treatment doing a wide range of exercises and then say at 6 month and 12 month follow up dates? Reason I ask is because even for a person with sci it would be easier to follow what the person has regained even though we already know what were looking at. It just seems to me that if you did so it would be ALOT easier to follow for the people you are trying to get donations from if they were not firmiliar with sci. Kinda painting an easier picture for them to follow. Thanks

                Comment


                  Originally posted by FellowHawkeye View Post
                  Wise, you didn't quite answer Wills77 about your trials. Info I received in the mail about them say that they're focusing on those with chronic, complete sci injuries and says nothing about those with chronic, incomplete sci injuries or when/if incomplete injuries will be benefited by these trials. I'm pretty disappointed. There are more people with incomplete sci injuries, aren't there? And aren't they more likely to respond to your therapy since it also involves walking? They should be in the trials first or parallel to them, it seems to me. What do you think? Thanks...

                  Jan
                  Hi, Jan. It is true that there are more incomplete's than complete spinal spinal cord injuries. We originally wanted to do ASIA A, B, and C's in our trial in China. However, when we found that 75% of ASIA A patients recover KLS IV at 6-12 months after umbilical cord blood mononuclear cells (UCBMC) treatment, it became clear that the most efficient way of demonstrating that UCBMC is effective is to do a trial on only ASIA A subjects. It reduces the number of subjects that we do from 400 to only 120 in China and then 120 subjects around the world (including the U.S.).

                  Please understand that that this is not a reflection of our commitment to therapies for incomplete SCI. I have many friends with incomplete SCI, including of course you. We are absolutely committed to curing not only complete but incomplete SCI. On the other hand, while it was not an easy decision, it is an obvious decision. If we get the treatment approved first for complete spinal cord injury, then it is just a matter of doing some phase II/III trials showing that the treatment is safe and effective to get approval for "incomplete" injuries.

                  I hope that the first "success" will help bring in more funding for clinical trials. Believe me, this is not the first best and the only therapy for spinal cord injury. It is just the first that is showing results. We need to make sure that it is real and is credible to the doctors of the world. More important, this must be a consistent and constant effort that goes on around the world, to test the promising therapies of spinal cord injury in a rigorous and safe way, to establish the best therapies of chronic spinal cord injury. We will do trials to test therapies for incomplete spinal cord injury.

                  Wise.

                  Comment


                    Originally posted by havok View Post
                    This may be unrelated to this thread but I have read in several places that the Chinese government is dumping billions into medical research. anywhere from 20 to 60% growth. I'm curious if any of this has helped with the finacial burden with SCI research including your own in China? And on the flip side the US cuts here in the US :/
                    Havok,

                    In China, our current costs for doing clinical trials is about US$20,000 per subject, compared to US$100,000 in the U.S. The Chinese government now commits about 3.5% of their GDP to academic education and research. They recently announced that they are increasing it to 4.0% of their GDP and committing this it to translational research, including clinical trials. While ChinaSCINet has not directly received funding from the Chinese government, many of our participating centers have received grants from the Chinese government for clinical trials, allowing us to proceed with our work. We have been teaching many of the centers in China to do spinal cord injury research and clinical trials and helping them with their applications for grants. Things are highly competitive in China, as you can imagine.

                    Wise.

                    Comment


                      Originally posted by kimg View Post
                      I see you are doing phase 111 trials for asia a complete injuries how can I participate in the trials?
                      Kimg, if you are in China or Hong Kong, please wait until we announce the trials in China and the clinical trial centers. Then you need to contact the trial centers to join the trials.

                      Wise.

                      Comment


                        Originally posted by #LHB# View Post
                        Dr Young. Have you or have you ever thought off video taping the patient before treatment doing a wide range of exercises and then say at 6 month and 12 month follow up dates? Reason I ask is because even for a person with sci it would be easier to follow what the person has regained even though we already know what were looking at. It just seems to me that if you did so it would be ALOT easier to follow for the people you are trying to get donations from if they were not firmiliar with sci. Kinda painting an easier picture for them to follow. Thanks
                        #LHB#,

                        There are videotapes of the subjects walking. However, we don't have video of the subjects doing a "wide range of exercises at 6 months and 12 months". Let me try to change your frame of reference here. Please understand that the spinal cord injury community is not the primary target of the clinical trials. We do clinical trials for three reasons:
                        1. To convince regulatory agencies that the therapy is safe and effective. In most countries of the world, therapies cannot be practiced unless they are approved by the appropriate regulatory agencies.
                        2. To convince doctors that the therapy is safe and effective so that they are willing to apply the therapy to their patients. They will not do so unless the therapy is approved by appropriate regulatory agencies.
                        3. To convince insurance agencies that the therapy is cost-effective. They will of course not pay unless the therapy has been approved by regulatory agencies and both doctors and patients want to have the the therapy.


                        I am personally not in favor of hyping a therapy at phase II levels. Once we have phase III evidence that the treatment is effective, that is the time when we must mobilize to get the therapy accepted. I have done many clinical trials and while the current results are very promising, we need to confirm them in rigorous phase III trials before I am willing to say that the treatment really works.

                        As a member of the spinal cord injury community, it is important that you support the trials but not jump overboard. The trial results need confirmation. After all, we have disparate results from two trials, one in Hong Kong and one in Kunming. The former suggests that MR/DTI images of fibers growing across the injury site in in 2 of 5 subjects at 1.0-1.5 years after treatment. The latter suggests that 75% of subjects can recover minimally assisted walking at 6-12 months after injury but without corresponding improvements in motor and sensory scores.

                        Yes, I am excited and optimistic about the prospects of umbilical cord blood mononuclear cells (UCBMC) therapy but I am only human and have many friends that I would love to see walk. I spend a lot of time thinking about this but the driving force in my mind is that we need to make sure that this is true. For 30 years, I have been conducting clinical trials. The results are often unexpected. In 1989, I was surprised by the results of NASCIS II showing that methylprednisolone improves recovery by 20% over controls.

                        It is awful, isn't it, that neurosurgeons recently decided that they will not recommend high-dose methylprednisolone (MP) for acute spinal cord injury, because they are afraid of lawsuits, even though they don't have any data to contradict that rigorous clinical trials that showed that MP is effective in acute spinal cord injury. The fight to show that therapies are effective is not just about winning the hearts and minds of people with spinal cord injury but the approval of regulatory agencies, doctors, and insurance agencies that control medical care.

                        We need to get the first therapy of chronic spinal cord injury established in the minds of the regulatory agencies, doctors, and insurance agencies. This paves the way for all others to follow.

                        Wise.
                        Last edited by Wise Young; 29 Apr 2013, 8:36 AM.

                        Comment


                          Originally posted by Wise Young View Post
                          #LHB#,



                          There are videotapes of the subjects walking. However, we don't have video of the subjects doing a "wide range of exercises at 6 months and 12 months". Let me try to change your frame of reference here. Please understand that the spinal cord injury community is not the primary target of the clinical trials. We do clinical trials for three reasons:
                          1. To convince regulatory agencies that the therapy is safe and effective. In most countries of the world, therapies cannot be practiced unless they are approved by the appropriate regulatory agencies.
                          2. To convince doctors that the therapy is safe and effective so that they are willing to apply the therapy to their patients. They will not do so unless the therapy is approved by appropriate regulatory agencies.
                          3. To convince insurance agencies that the therapy is cost-effective. They will of course not pay unless the therapy has been approved by regulatory agencies and both doctors and patients want to have the the therapy.
                          I am personally not in favor of hyping a therapy at phase II levels. Once we have phase III evidence that the treatment is effective, that is the time when we must mobilize to get the therapy accepted. I have done many clinical trials and while the current results are very promising, we need to confirm them in rigorous phase III trials before I am willing to say that the treatment really works.

                          As a member of the spinal cord injury community, it is important that you support the trials but not jump overboard. The trial results need confirmation. After all, we have disparate results from two trials, one in Hong Kong and one in Kunming. The former suggests that MR/DTI images of fibers growing across the injury site in in 2 of 5 subjects at 1.0-1.5 years after treatment. The latter suggests that 75% of subjects can recover minimally assisted walking at 6-12 months after injury but without corresponding improvements in motor and sensory scores.

                          Yes, I am excited and optimistic about the prospects of umbilical cord blood mononuclear cells (UCBMC) therapy but I am only human and have many friends that I would love to see walk. I spend a lot of time thinking about this but the driving force in my mind is that we need to make sure that this is true. For 30 years, I have been conducting clinical trials. The results are often unexpected. In 1989, I was surprised by the results of NASCIS II showing that methylprednisolone improves recovery by 20% over controls.

                          It is awful, isn't it, that neurosurgeons recently decided that they will not recommend high-dose methylprednisolone (MP) for acute spinal cord injury, because they are afraid of lawsuits, even though they don't have any data to contradict that rigorous clinical trials that showed that MP is effective in acute spinal cord injury. The fight to show that therapies are effective is not just about winning the hearts and minds of people with spinal cord injury but the approval of regulatory agencies, doctors, and insurance agencies that control medical care.

                          We need to get the first therapy of chronic spinal cord injury established in the minds of the regulatory agencies, doctors, and insurance agencies. This paves the way for all others to follow.

                          Wise.
                          Thank you for the responce. It is sad that they stoped giving MP to acutes. Then again if it was there son or daughter they would change there tune. I really didn't mean video the patients to overhype the trial when you dont know the final result yeat. I didn't explane myself very well. More like the sad HSUS videos you see on tv. It makes alot of people donate alot of money. Thats more what I was going for, the donation side of it. Seem's to me people like to see and visualize the diffrence there donation would make in someones life. Just a thought.

                          Comment


                            Doctor, have you noticed a difference in recovery between the different groups of cell dosage size? In other words, would it be safe to say yet that the 6.4 million cell dosage is more beneficial than 1.6 million? Or maybe it can even be answered this way, Of the couple patients that were able to walk better than KLS IV, could this be attributed to the high cell dosage?
                            Will we have to wait for the published papers to understand if any patients have any bowel,bladder and or sexual function recovery?

                            Comment


                              Originally posted by Wise Young View Post
                              #LHB#,

                              There are videotapes of the subjects walking. However, we don't have video of the subjects doing a "wide range of exercises at 6 months and 12 months". Let me try to change your frame of reference here. Please understand that the spinal cord injury community is not the primary target of the clinical trials. We do clinical trials for three reasons:
                              1. To convince regulatory agencies that the therapy is safe and effective. In most countries of the world, therapies cannot be practiced unless they are approved by the appropriate regulatory agencies.
                              2. To convince doctors that the therapy is safe and effective so that they are willing to apply the therapy to their patients. They will not do so unless the therapy is approved by appropriate regulatory agencies.
                              3. To convince insurance agencies that the therapy is cost-effective. They will of course not pay unless the therapy has been approved by regulatory agencies and both doctors and patients want to have the the therapy.


                              I am personally not in favor of hyping a therapy at phase II levels. Once we have phase III evidence that the treatment is effective, that is the time when we must mobilize to get the therapy accepted. I have done many clinical trials and while the current results are very promising, we need to confirm them in rigorous phase III trials before I am willing to say that the treatment really works.

                              As a member of the spinal cord injury community, it is important that you support the trials but not jump overboard. The trial results need confirmation. After all, we have disparate results from two trials, one in Hong Kong and one in Kunming. The former suggests that MR/DTI images of fibers growing across the injury site in in 2 of 5 subjects at 1.0-1.5 years after treatment. The latter suggests that 75% of subjects can recover minimally assisted walking at 6-12 months after injury but without corresponding improvements in motor and sensory scores.

                              Yes, I am excited and optimistic about the prospects of umbilical cord blood mononuclear cells (UCBMC) therapy but I am only human and have many friends that I would love to see walk. I spend a lot of time thinking about this but the driving force in my mind is that we need to make sure that this is true. For 30 years, I have been conducting clinical trials. The results are often unexpected. In 1989, I was surprised by the results of NASCIS II showing that methylprednisolone improves recovery by 20% over controls.

                              It is awful, isn't it, that neurosurgeons recently decided that they will not recommend high-dose methylprednisolone (MP) for acute spinal cord injury, because they are afraid of lawsuits, even though they don't have any data to contradict that rigorous clinical trials that showed that MP is effective in acute spinal cord injury. The fight to show that therapies are effective is not just about winning the hearts and minds of people with spinal cord injury but the approval of regulatory agencies, doctors, and insurance agencies that control medical care.

                              We need to get the first therapy of chronic spinal cord injury established in the minds of the regulatory agencies, doctors, and insurance agencies. This paves the way for all others to follow.

                              Wise.
                              I bet regardless of the trial results they will fight tooth and nail to deny that it works. For some reason that seems to be the way..

                              Comment


                                Originally posted by Wise Young View Post
                                Havok,

                                In China, our current costs for doing clinical trials is about US$20,000 per subject, compared to US$100,000 in the U.S. The Chinese government now commits about 3.5% of their GDP to academic education and research. They recently announced that they are increasing it to 4.0% of their GDP and committing this it to translational research, including clinical trials. While ChinaSCINet has not directly received funding from the Chinese government, many of our participating centers have received grants from the Chinese government for clinical trials, allowing us to proceed with our work. We have been teaching many of the centers in China to do spinal cord injury research and clinical trials and helping them with their applications for grants. Things are highly competitive in China, as you can imagine.

                                Wise.
                                Thank you for the reply. Its really great to see the government is putting money into medical research, and as you said its even cheaper to conduct trials there. I truely believe China is on its way to leading the world in scientific discovery and the US is continuing to shoot itself in the foot. Well hopefully success with the current trial will warrent attention from the Chinese government for funding. Good luck and thank you for all your work.
                                T6 complete since 3/21/2012

                                Comment

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