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    Originally posted by peterf View Post
    T8 i do believe that this is also being discussed in another thread
    Personally i do believe that professional opinion and personal observation by a professional
    can easily get mixed up in internet forums and turn into wildfires the likes we have already.
    seen. Anyway we are a community of friends fighting the same cause so honest comment is welcome.
    I don't read every thread, so I apologize if this is duplicated somewhere. I think Wise is extremely careful about what he posts due to a lot of very self-evident reasons and there are no "personal observations" involved by him. I will never understand people who doubt his sincerity or attack him personally or professionally. He is a person who is not infallible but the sincerity and dedication to people with SCI cannot be doubted. I am genuinely puzzled by people that do and worry that these "wildfires" will put him off of posting here and we will lose a valuable insight into our hopes for a cure.

    Comment


      Originally posted by paolocipolla View Post
      Stem Cell inc. provided an update based on data from multiple evaluations of the patients and on that base decided to move to ASIA B patients.
      http://investor.stemcellsinc.com/pho...071&highlight=

      So my point was that you have provided people some esily misunderstandable info IMO based on your personal evaluation.
      I was hoping you could provide info based on multiple evaluations of the patients (which you have done for sure since you decided to move to phase 3 to clear any doubt.

      If I put it like that does it make more sense?

      Paolo
      Paolo,

      It is not true that Stem Cells Inc. provided detailed outcomes data in their announcement. They basically said something similar to what I said, i.e. the treatment is safe, there are some improvements, and the data have encouraged them to move forward to the next planned phase of the trial.

      Our criteria for moving forward to the phase 3 trial is that the transplants are safe, and there should be motor and sensory improvement. In my opinion, the phase 2 trial has fulfilled these criteria, and we are moving to the next phase of the trial.

      If people want to know the details of the recovery and its relationship to treatment dose and imaging results, they will simply have to wait until the formal data have been collected, analyzed, and published. Detailed outcomes data should not and will not be provided while the trial is still going on.

      If you don't want to believe that the some subjects are walking, that's all right but please stop implying that I have lied about some subjects walking to increase optimism or raise funds. That is not only false and insulting but damaging to the field.

      Wise.

      Comment


        Thank Wise today from the bottom of your heart, that you are saved by science and by faith in Him alone.

        Comment


          Originally posted by Wise Young View Post
          Paolo,

          It is not true that Stem Cells Inc. provided detailed outcomes data in their announcement. They basically said something similar to what I said, i.e. the treatment is safe, there are some improvements, and the data have encouraged them to move forward to the next planned phase of the trial.

          Our criteria for moving forward to the phase 3 trial is that the transplants are safe, and there should be motor and sensory improvement. In my opinion, the phase 2 trial has fulfilled these criteria, and we are moving to the next phase of the trial.

          If people want to know the details of the recovery and its relationship to treatment dose and imaging results, they will simply have to wait until the formal data have been collected, analyzed, and published. Detailed outcomes data should not and will not be provided while the trial is still going on.

          If you don't want to believe that the some subjects are walking, that's all right but please stop implying that I have lied about some subjects walking to increase optimism or raise funds. That is not only false and insulting but damaging to the field.

          Wise.
          Wise read more carefully please,
          I said Stem Cell Inc. based the decision to move forward on data from multiple evaluations of the patients and on that base decided to move to ASIA B patients. So they have collected the data, examinated them and made the decision.
          I didn't say they made the data available.
          My point was that you said you reported "personal evaluations" and based on that the decision to move to phase III.
          Please don't twist my words.
          In any case I will be happy to shut up once you will provide scientific evidence that people that were asia A not walking before are now walking (as the definition of walking posted before) no matter if it was due to the UCB + Li, the surgery or rehab which you would find out just in phase III.

          I expect that if you have enrolled patients ASIA A that were not walking and now some are walking it should be very easy to provide scientific evidece for that soon as it should be easier then prove sensation returns or minor motor recovery.

          I'll be waiting for that scientific evidence that hopefully you will provide very soon.

          Paolo
          In God we trust; all others bring data. - Edwards Deming

          Comment


            Paolo, perhaps you should read carefully what you said. I have not twisted your words. You have suggested that I am claiming that subjects in the trial are walking in order to increase optimism and to raise funds. You have been demanding that I provide proof of the walking and brought up the Stem Cell Inc. disclosure that they have decided to go onto the next phase of the trial because they have data that the treatment is safe, there were some improvements, and have decided to go on to the next phase of the trial. I pointed out that they did not provide detailed outcome data and I have made a very similar statement, that we are going on to phase 3 trial because the cell transplants seem safe, that many subjects are having some sensory improvement, and some subjects are walking. You seem to have some kind of problem with the fact that I have observed some subjects walking. I have explained why I cannot disclose the data now. As soon as all the data is collected and analyzed, we will publish the data and everybody, including you, can judge. Wise.

            Originally posted by paolocipolla View Post
            Wise read more carefully please,
            I said Stem Cell Inc. based the decision to move forward on data from multiple evaluations of the patients and on that base decided to move to ASIA B patients. So they have collected the data, examinated them and made the decision.
            I didn't say they made the data available.
            My point was that you said you reported "personal evaluations" and based on that the decision to move to phase III.
            Please don't twist my words.
            In any case I will be happy to shut up once you will provide scientific evidence that people that were asia A not walking before are now walking (as the definition of walking posted before) no matter if it was due to the UCB + Li, the surgery or rehab which you would find out just in phase III.

            I expect that if you have enrolled patients ASIA A that were not walking and now some are walking it should be very easy to provide scientific evidece for that soon as it should be easier then prove sensation returns or minor motor recovery.

            I'll be waiting for that scientific evidence that hopefully you will provide very soon.

            Paolo

            Comment


              It isn't that hard - he can't release the data yet. When it is published, we will see.

              Don't bite the hand that feeds you.

              Comment


                Originally posted by MarcT View Post
                Don't bite the hand that feeds you.


                Unbelievable, that some people are so stupid
                keep (rolling) Walking

                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

                Comment


                  Originally posted by Johnnie Walker View Post


                  Unbelievable, that some people are so stupid
                  I agree!

                  Paolo
                  In God we trust; all others bring data. - Edwards Deming

                  Comment


                    Originally posted by Wise Young View Post
                    Paolo, perhaps you should read carefully what you said. I have not twisted your words. You have suggested that I am claiming that subjects in the trial are walking in order to increase optimism and to raise funds. You have been demanding that I provide proof of the walking and brought up the Stem Cell Inc. disclosure that they have decided to go onto the next phase of the trial because they have data that the treatment is safe, there were some improvements, and have decided to go on to the next phase of the trial. I pointed out that they did not provide detailed outcome data and I have made a very similar statement, that we are going on to phase 3 trial because the cell transplants seem safe, that many subjects are having some sensory improvement, and some subjects are walking. You seem to have some kind of problem with the fact that I have observed some subjects walking. I have explained why I cannot disclose the data now. As soon as all the data is collected and analyzed, we will publish the data and everybody, including you, can judge. Wise.
                    Wise,

                    I said that:
                    "I think it is possible that Wise just wants to spread optimism, but many people would say that he does it to get more donations..."
                    /forum/showpost.php?p=1539892&postcount=57

                    You are saying: "You have suggested that I am claiming that subjects in the trial are walking in order to increase optimism and to raise funds."

                    I think it is clear that what I said is very different from what you say I would have said.

                    Please don't twist my words.

                    In any case in a few months hopefully we'll have scientifc evidence that these people are walking so I will shut up.. or you will be in trouble.

                    As you said: "My heart leaps whenever an investigator in trials that I am doing says that somebody is walking or whatever. Objectivity is not possible when you care."

                    /forum/showpost.php?p=1466476&postcount=31

                    Paolo
                    In God we trust; all others bring data. - Edwards Deming

                    Comment


                      Paolo ,
                      Please shut up . Over

                      Comment


                        in agreement with duck, paolo, please shut the fuck up

                        Comment


                          Wise.

                          Dr. Young, Thank you for giving us progress updates of your trial to keep so many SCI’s and families hopeful of the future. Thou you might not always hear all of the appreciation or even know how many people see your work….many grateful followers are out here cheering you on. In an effort to stimulate the conversation into a more positive direction I’m asking more questions!

                          1. Regarding the blood cord question I read the occurrence of a parent:sibling 6:6 match is about 5%. I understand if you can’t answer this question until after the study, but are the HLA’s matches used in the study an exact match of 6:6? It seems the possibility of finding an exact match would be pretty good with the so many large donation banks.

                          Here is another post I finally was able to find discussing this issue
                          /forum/archive/index.php/t-93588.html

                          I found this info, hopefully it will help others out there with the same questions. It’s not in reference to Spinal Cord injections.

                          “Hla Statistics

                          In the United States, approximately 30% of patients have an HLA identical sibling. A smaller portion, less than 5%, will match a parent or an offspring. The likelihood of finding at least one match among n siblings is 1 – (0.75).

                          - The incidence of GVHD and graft failure increases with increasing HLA disparity. Generally, an unrelated donor is sought if a 5/6 HLA-A, B, DR matched relative cannot be found. There is some debate about whether a 6/6 unrelated donor is preferable to a 5/6 HLA-matched relative, but most feel that these donors are equivalent, and it is often easier from a logistic viewpoint to arrange the stem cell donation from a related donor.
                          - In umbilical cord blood transplantation, the immaturity of the donor immune system allows a greater degree of HLA disparity (e.g., 4/6 matches), although even here better matches are associated with better outcomes.”
                          http://stem-cell-transplant.blogspot.com/2010/02/hla-matching-in-allogeneic.html


                          2. In regard to the not more than “3 segment” exclusion criteria, can you explain this in more detail? Does this mean 4 vertebra and three discs long? Does this equate to some length in centimeters?

                          3. Seeing the constant skepticism that surrounds all cures related to SCI’s I’m glad that you are using chronic ASIA A’s to completely confirm reasonable doubt. Using a group of patients that have at some point after their injury been involved in an intense rehabilitation program and tried to walk to know the exact effect on their body compared to the treatment after the combination would be a complete validation of the improvement, but I’m sure this has been discussed.

                          Thank you again!

                          Comment


                            Originally posted by Duck View Post
                            Paolo ,
                            Please shut up . Over
                            Are you asking me or are you telling me?

                            My intention here is to provide a critical angle to look at the situation. I am sure over the years you have seen many CC members doing that and I have learned a lot from them.

                            In the same way recently Dr. Silver has provided us many scientific different views on SCI research and I think that has added significant value to this forum.

                            Paolo
                            In God we trust; all others bring data. - Edwards Deming

                            Comment


                              Originally posted by lakboy View Post
                              in agreement with duck, paolo, please shut the fuck up
                              That is not very kind of you, but thank you for paying attention to my posts.

                              Paolo
                              In God we trust; all others bring data. - Edwards Deming

                              Comment


                                Walking again,

                                Thank you very much for your comments.

                                In our trials to date, we have used only umbilical cord blood units that have ≥4:6 HLA match with the donor. About a quarter of our patients so far have had 6:6 HLA match. Close to half have 4:6. We of course don’t know whether HLA-matching is necessary but our hypothesis is that better-matched cells may survive longer and have more influence on the spinal cord. Almost everybody was able to get 4:6 or better match.

                                The three segment exclusion is based on our protocol of injecting cells above and below the injury site. If the injury length is too long, i.e. greater than 2 segments, we have to do a 3-segment laminectomy. To avoid this, we are limiting spinal cord injuries to less than 3 segments.

                                To date, we have only treated subjects that are more than one year after injury with stable neurological function for at least 6 months. The age range is 18-60 for the current study. We will likely expand this to 18-64 in the coming U.S. trials and also design a trial for people who are 65-80 years old. Many of our subjects in China are 10 years or longer after spinal cord injury.

                                The subjects in Kunming have been walking as much as 6 hours a day, using a rolling cart upon which they could rest some of their weight, shown in the attached picture. I have described this walking procedure many times both on carecure as well as many open houses. Each subject progresses throught the various stages in sequence.

                                In the beginning, all of them just stood with somebody holding their knees. Then many began to stand on their own and started taking steps while leaning on the rolling cart. They wear elastic bands that are put in figure-8 around the ankles to prevent their feet from dragging on the ground.

                                Once they start walking, a nurse, family member, or trainer walks behind them with ropes tied to their knees, to lock the knees in stance phase so that the subjects can support their weight while walking. Eventually, some of them don’t need somebody walking behind them and are simply walking with the aid of the rolling cart that provides partial weight support.

                                The Kunming group categorizes the walking into I-X, shown in the attached picture. As you can see, none of the phases include walking with braces. We generally consider subjects who are walking in category V or higher to be unassisted locomotion. Yes, they are using a device but there is no human assistance. Almost all the patients were only at category II and possibly III at the beginning of the study.

                                Since this is the first time that we have been asking subjects who have chronic spinal cord injury to engage in intensive locomotor training, we have been particularly interested in the incidence of fractures that might occur when people spend so much of their time on their feet. In February, two subjects complained of pain in a part of their legs and x-ray showed fractures. However, upon review of older x-rays, it appears that both subjects had fractures in the same area before, so they apparently did not have a new fracture at the site.

                                Wise.

                                Originally posted by walkingagain View Post
                                Wise.

                                Dr. Young, Thank you for giving us progress updates of your trial to keep so many SCI’s and families hopeful of the future. Thou you might not always hear all of the appreciation or even know how many people see your work….many grateful followers are out here cheering you on. In an effort to stimulate the conversation into a more positive direction I’m asking more questions!

                                1. Regarding the blood cord question I read the occurrence of a parent:sibling 6:6 match is about 5%. I understand if you can’t answer this question until after the study, but are the HLA’s matches used in the study an exact match of 6:6? It seems the possibility of finding an exact match would be pretty good with the so many large donation banks.

                                Here is another post I finally was able to find discussing this issue
                                /forum/archive/index.php/t-93588.html

                                I found this info, hopefully it will help others out there with the same questions. It’s not in reference to Spinal Cord injections.

                                “Hla Statistics

                                In the United States, approximately 30% of patients have an HLA identical sibling. A smaller portion, less than 5%, will match a parent or an offspring. The likelihood of finding at least one match among n siblings is 1 – (0.75).

                                - The incidence of GVHD and graft failure increases with increasing HLA disparity. Generally, an unrelated donor is sought if a 5/6 HLA-A, B, DR matched relative cannot be found. There is some debate about whether a 6/6 unrelated donor is preferable to a 5/6 HLA-matched relative, but most feel that these donors are equivalent, and it is often easier from a logistic viewpoint to arrange the stem cell donation from a related donor.
                                - In umbilical cord blood transplantation, the immaturity of the donor immune system allows a greater degree of HLA disparity (e.g., 4/6 matches), although even here better matches are associated with better outcomes.”
                                http://stem-cell-transplant.blogspot.com/2010/02/hla-matching-in-allogeneic.html


                                2. In regard to the not more than “3 segment” exclusion criteria, can you explain this in more detail? Does this mean 4 vertebra and three discs long? Does this equate to some length in centimeters?

                                3. Seeing the constant skepticism that surrounds all cures related to SCI’s I’m glad that you are using chronic ASIA A’s to completely confirm reasonable doubt. Using a group of patients that have at some point after their injury been involved in an intense rehabilitation program and tried to walk to know the exact effect on their body compared to the treatment after the combination would be a complete validation of the improvement, but I’m sure this has been discussed.

                                Thank you again!

                                Comment

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