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Jerry Silver and Other Discussion from ChinaSCINet Update

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    Originally posted by Christopher Paddon View Post
    If we rely on actual published peer reviewed animal research studies in good scientific journals and clinically relevant data to help with SCI recovery we should find whether or not the scar is a barrier and perhaps eventually therapies that will overcome all the obstacles to regeneration.
    In the coming months we will be able to rely on an actual peer reviewed HUMAN research study published in a good scientific journal with clinically relevant data to help with SCI recovery.

    If Dr. Silver says he's observed axons growing past the scar wall without a scaffold and Dr. Wise says he, too, has observed axons growing past the scar wall without a scaffold, then perhaps axons can somehow grow beyond the scar wall without a scaffold.

    Comment


      Originally posted by quadfather View Post
      Clinical trials for chronics is a big deal. Just like the University of Florida embryonic tissue trial on chronics done in the 90s and the Diacrin stem cell trial on chronics done 12 years ago (BTW both failed). My point is that we need more trials for chronics. Let's do that rather than this. We 1000 trials per day to be starting. Then maybe one will hit.
      Embryonic stem cells and neural pig cells < HLA matched umbilical cord blood mononuclear cells (adult stem cells). HLA matched UCBMC are safe, much less likely to be rejected by the body and are already approved for use in the United States.

      Did Wise Young, or any prominent researcher for that matter, claim in either one of those trials to see DTI's suggesting robust axonal growth or that some of the subjects seemed to be recovering locomotor function?

      Where do you suggest we get the funding to run 1000 trials per day? Do you think a more efficient use of limited resources would be to focus them on one or two really promising therapies instead? Do you think that when the official study is published, confirming what Dr. Wise has been saying the whole time, it will make raising funds much easier?

      Comment


        It's also very important to remember that rats aren't nearly the same as us. Who knows how our CNS's will react to these therapies.

        Comment


          Originally posted by Jim View Post
          It's also very important to remember that rats aren't nearly the same as us. Who knows how our CNS's will react to these therapies.

          I've known a few dirty rats in my lifetime, so perhaps that research isn't so far off. *Bad joke over*

          Comment


            Originally posted by Jim View Post
            It's also very important to remember that rats aren't nearly the same as us. Who knows how our CNS's will react to these therapies.
            While this is certainly true, I don't think it's something to hang your hat on.
            You can't on the one hand tote animal studies as suggestive of the potential for a therapy, as Dr. Young has done in the case of umbilical cord blood, and then wave off criticisms based on animal studies because we just don't know how humans will react. Of course we don't know, until we try it on humans...but before then, convention is to test it on animals as they are our best indicator. Otherwise we're just pissing in the wind... I think though, besides the scar issue there's another fundamental difference between Dr.'s Young and Silver and that is the extent to which we should continue on animals vs. moving onto humans and what is the threshold of "promise" for a therapy that we need before moving from the former to the latter. I'm not taking a side here, but that's something that maybe should be discussed and clarified.

            Comment


              Originally posted by ay2012 View Post
              You can't on the one hand tote animal studies as suggestive of the potential for a therapy, as Dr. Young has done in the case of umbilical cord blood, and then wave off criticisms based on animal studies because we just don't know how humans will react.
              Jim isn't reducing or marginalizing the importance of testing therapies on animals. Animals and humans have both similarities and differences. His greater point is this:
              Originally posted by Jim View Post
              And remember, this is a Phase II Safety Study. It is a huge deal that the surgery and injection of cells into the [human] spinal cord is safe. This in itself is a major step forward. Anything else is icing on the cake.

              Comment


                That's certainly a great thing... But I don't think anything else is just icing on the cake. Perhaps, looking at the Phase II trial in isolation you could say this. But that's not what Dr. Silvers concern is. His concern is that efficacy won't be shown in Phase III, or at least there is not enough animal data to suggest it will be. His concerns he therapy in toto.
                If you're fine with therapy after therapy being proven safe and then not beneficial well that's your call. Dollars are scarce, as is time... And the best therapies should be chosen, and if there aren't yet therapies likely to help complete, chronics well back to the drawing board.
                To be honest, I'm very excited about this trial, the six month data, the Phase III moving forward and don't think Dr. Young would stake his reputation on something that hasn't shown any positive effects. Just playing devils advocate here...

                Comment


                  Originally posted by ay2012 View Post
                  Just playing devils advocate here...
                  I understand.

                  Originally posted by ay2012 View Post
                  But that's not what Dr. Silvers concern is.
                  Dr. Silver's concern = these trials, if/when confirmed, will show much of what he's believed and professed about spinal cord regeneration to be incorrect.

                  Originally posted by ay2012 View Post
                  If you're fine with therapy after therapy being proven safe and then not beneficial well that's your call.
                  Yes, no regeneration would have been disappointing. Proven safety still would've been encouraging though. Cutting open the body, exposing the spinal cord, *injecting the dura* with stem cells... it's radical. It's never been done before. Lots of stuff could've theoretically gone wrong. It didn't.

                  If the surgery proved safe but the stem cells didn't initially display efficacy (but showed efficacy in animals), all hope would not be lost. Researchers could've tried different injection methods/sites, using higher amounts of stem cells, different stem cells, etc. Had the very first DTI's from Hong Kong not shown robust axonal growth, maybe this would've been the case. Thank goodness for us, it's not.
                  Last edited by crabbyshark; 9 Jan 2013, 5:46 PM.

                  Comment


                    Originally posted by crabbyshark View Post
                    I understand.


                    If the surgery proved safe but the stem cells didn't initially display efficacy (but showed overwhelming efficacy in animals), all hope would not be lost. Researchers could've tried different injection methods/sites, using higher amounts of stem cells, different stem cells, etc. Had the very first DTI's from Hong Kong not shown robust axonal growth, maybe this would've been the case. Thank goodness for us, it's not.
                    You do know that there is no overwhelming efficacy of the treatment in animals right? That the treatment caused robust axonal growth has NOT been proven yet. Wait until the results are published and can stand up to critiques of the scientific community.

                    Comment


                      Originally posted by ay2012 View Post
                      While this is certainly true, I don't think it's something to hang your hat on.
                      You can't on the one hand tote animal studies as suggestive of the potential for a therapy, as Dr. Young has done in the case of umbilical cord blood, and then wave off criticisms based on animal studies because we just don't know how humans will react.
                      My intent wasn't to wave off criticism, I was making the point that this is uncharted territory and anything is possible. Maybe the treatment will be more effective in humans, maybe it won't work at all. Either way, a great deal is being learned and bringing us closer to effective therapies.

                      Comment


                        Originally posted by Jim View Post
                        My intent wasn't to wave off criticism, I was making the point that this is uncharted territory and anything is possible. Maybe the treatment will be more effective in humans, maybe it won't work at all. Either way, a great deal is being learned and bringing us closer to effective therapies.
                        Yea, this also 100% true, but would maybe further justify the skepticism of someone like Dr. Silver, who feels there weren't appropriate analogous animal studies to justify even trying the treatment on humans to begin with.
                        Just again to reiterate: these are all a priori reasons to maybe want to consider a different therapy (although I get the suspicion that Dr. Young would object in the context of a greater argument on the role of animal studies). Now that the trials are happening and have shown enough in the Phase II to seemingly justify a Phase III, they are besides the point.

                        Comment


                          Originally posted by NowhereMan View Post
                          You do know that there is no overwhelming efficacy of the treatment in animals right? That the treatment caused robust axonal growth has NOT been proven yet. Wait until the results are published and can stand up to critiques of the scientific community.
                          You are right that "overwhelming" is too strong of a word. I will change that. There's certainly "convincing" evidence in animal models (here, here, here, here, and from 25:50-26:15 here) to suggest stem cell therapies are probably contributing to spinal cord regeneration in animals.

                          You are right that this particular treatment has "NOT" been proven yet... but if Dr. Wise says there's evidence suggesting it's working, then I think there's probably evidence suggesting it's working.
                          Last edited by crabbyshark; 9 Jan 2013, 8:45 PM.

                          Comment


                            Originally posted by crabbyshark View Post
                            You are right that "overwhelming" is too strong of a word. I will change that. There's certainly "convincing" evidence in animal models (here, here, here, here, and from 25:50-26:15 here) to suggest stem cell therapies are probably contributing to spinal cord regeneration in animals.

                            You are right that this particular treatment has "NOT" been proven yet... but if Dr. Wise says there's evidence suggesting it's working, then I think there's probably evidence suggesting it's working.
                            None of these are "convincing" evidence of efficacy of the treatment.

                            1st link -- this was using olfactory ensheathing cells, not umbilical cord blood cells. They are not homogenous just because they happen to both be stem cells. I'm not even sure UCB cells are stem cells. I also can't find the paper online to see images of axon regeneration in the dogs.

                            2nd link -- this was in an acute model, not chronic. It was also in an incomplete injury model. Even then, BBB scores increased from 11 to 13.5. That doesn't impress me at all.

                            3rd link -- this was in a incomplete model. I assume it was also in an acute model as well, but I'm not sure as the abstract did not say.

                            4th link -- this was in an acute model. It did not regenerate any axons but prevented secondary axon damage. Big difference.

                            5th link -- from what I heard, I think Dr. Young was showing how the UCB cells that they implanted migrated into the injury site, he wasn't showing axons growing into the injury site.


                            This is a chronic injury and complete injury trial. There are NO animal studies, that I am aware of, showing robust axon growth using Umbilical cord blood cells in a complete/chronic model. I understand that it is impossible to test HLA matching cells on animals, but that does not mean that animal studies showing efficacy exist. Again, wait until the results are published and the scientific community has a chance to respond before you are so certain of the results.

                            Comment


                              It's all about the data, speculation until then.

                              Comment


                                Originally posted by Jim View Post
                                It's all about the data, speculation until then.
                                Yep, pretty much...

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