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Regeneration vs Cell Replacement Therapies

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    Dogger -

    I admit I was a little tired when I wrote that. Essentially the whole thing was just a brain dump & I wasn't referring to anything specifically. You bring up a good point I haven't heard much talk about. I too would be curious to find out a little more. Come to think of it, could malpractice suits occur on an international level?

    Susan et al, what'd the doctors tell you prior to you receiving treatment? What kind of stuff did you have to sign?

    Good question. But let's not get too off track here. [img]/forum/images/smilies/wink.gif[/img]

    Comment


      Scott,

      I strongly support clinical trials and think that it is very important for our government to fund such trials for spinal cord injury because the therapeutic industry considers spinal cord injury to be too small a market to invest into clinical trials. The government also has the most to gain economically from therapies that restore function because they pay most of the care costs of spinal cord injury.

      Animal experiments are essential for reducing the risk of failure in spinal cord injury clinical trials. Because clinical trials are so expensive, a therapy usually has only one chance or at most two chances to succeed. A single failure is sufficient to stop further trials. If you have the wrong dose, the wrong timing, the wrong duration, or even not enough patients, the clinical trial may not show significant results. Many therapies have failed in clinical trial because of insufficient preclinical data.

      Please don't forget that animal studies gave us all the therapies that we have today. If we did not have animal studies, we would not even be thinking about olfactory ensheathing glia, much less therapies such as chondroitinase, rolipram and db cAMP, chondroitinase, GDNF, L1, and many other approaches that are now being proposed for clinical trial. We would not even know about stem cells. To slow down animal studies in favor of clinical trials is a recipe for failure in the search for a cure. There is also only so much that can be done in people.

      Participation in a clinical trial is a service to the community. Because the risk-benefit ratio of the therapy is uncertain, the person shoulders the risk in order that the community can learn from the experience. Individual cases are useful for demonstrating feasibility and risk but that is only the first step of the clinical trial process. In order for a therapy to be accepted and widely applied by the clinical community, convincing evidence of efficacy must be attained. That is what phase 3 trials must achieve. If not, the therapy may not see the light of day.

      If a clinical trial is poorly designed and exposes people to unnecessary risks, it jeopardizes the future of the therapy. If the data obtained is not credible, it is a waste of money and the people who have shouldered the risk of the therapy. A single mortality in a poorly designed and executed clinical trial can and will shut down a therapy prematurely for everybody and have enormous ramifications for the whole field. The Jesse Gelsinger case clearly illustrates this frightening possibility.

      Wise.

      Comment


        Originally posted by scott pruett:

        Yes, by all means keep using rats. But let's open up the floodgates & get some human trials going (yes, I know, collectively we're working towards that goal). No, it won't be perfect. Sure, funding is an issue. But is it an impossible barrier to take down? Nope. Do we necessarily have to wait on the government? Nope. Where there's a will, there's a way.

        Look for the Clinical Trial Network in China that Suzanne Poon and Dr. Young are working to get up and running soon! [img]/forum/images/smilies/smile.gif[/img]

        Dr. Young, Jesse Gelsinger died from very preventable medical mal-practice which was unrelated to the actual trial parameters.
        It was a silly yet deadly mistake that occurred which could have been easily prevented with the proper "double-checking" of medication administration levels.

        "We have a chance to take a giant stride forward for the good of all humanity" in the next election. "We can choose between the future and the past, between reason and ignorance, between true compassion and mere ideology."- Ron Reagan Jr.

        Comment


          dr. young,
          hi, have you ever done experiment on cats or dogs?what i am trying to ask is have you ever done the same experiment (any sci experiment) on cat or dog and rats? if the answer is yes, did you get exactly the same result? was the quality and quantity ( % of function, sensation) of the results the same or did you get better result with cats and dogs than rats (by comparison)?
          thanks

          Comment


            kz, I use to study spinal cord injury in cats in the 1980's. In fact, all the data on methylprednisolone treatment of spinal cord injury come from cats. In 1987, the USDA regulations concerning animals changed and it became too expensive to use cats. We therefore developed the rat spinal cord contusion model that is now the standard model in the field. There are of course differences between cat and rat spinal cord, the most obvious of which is the size difference. There are also some differences in the spinal tracts of the two species. There have been few comparisons of treatments in two species. Methylprednisolone is probably one of the few treatments that have been tested in both species and my impression is that the treatment has more effect on the cat spinal cord than the rat but it does have effects on the rat.

            Wise.

            Comment


              Luigi,
              I appologize for the length of time it took me to respond, please forgive me.

              When i said that i payed a high price and have no regrets, i did. Scott hit the nail on the head in regards to the cost, but i also put my life on the line and felt very priviledged at that point in my life to do so with the hopes that i would be cured. I believed that i would be cured and still do! There where also other risks because the procedure was very new, such as, i did not know if i would ever taste delicious food again or smell anything. Fourtanatly, this was not the case and my sense of taste and smell came back within a week or so. Once again, i have no regrets and smile upon doctors that truly try and restore what has been broken in intelligent procedures.. I look forward for my next time to pay that "high price"!
              Gods speed for a cure~
              Susan

              Comment


                Speaking of the Gelsinger case...I have heard anecdotally that one of Dr. Lima's patients died within a week of having the nasal OEG transplant procedure. Anyone else hear this?

                *************
                AB wife of T8 complete para
                *************
                AB wife of T8 complete para

                Comment


                  Belle,

                  Nope, never heard of this one, everyone is alive and still using wheelchairs. [img]/forum/images/smilies/frown.gif[/img]

                  Gods speed~
                  Susan

                  [This message was edited by Superstar on 09-01-04 at 03:06 PM.]

                  Comment


                    Originally posted by scott pruett:

                    I've been out of the cure forum loop for a couple weeks, but had a brief chat w/ superstar tonight, which prompted me to check this out.

                    I have to say that I do agree with Susan's perspective here. Wise, please know that I highly respect your professional stance; my father is a surgeon & I know there are a gazillion issues to consider... but for the sake of finding a cure for SCI, please give the rebels among us a chance to plow through some uncharted territory here. Sure, scientifically it may sound unwise, but it goes back to the point that there are some of us who are simply desperate to keep the ball rolling faster than data from lab rats will.

                    Sure, it helps to be smart about what steps to take (pardon the pun), and knowing which to avoid. I do understand there are risks. Personally some of those I'm not willing to take... but there are folks who will. It sounds harsh, but in reality, look at CJO, Handibob, qbclay, Susan, and several others who have invested big bucks into experimental treatments... for what? They didn't know what to expect. But hope drove them to try.

                    They are the pioneers that we are learning first hand from. They've taken huge risks physically and financially. But they've told us a lot, and I value their feedback a whole lot more than data taken from lab animals who don't have any sense of what real life consists of for us as individuals in society. Let's not even forget how Susan & Laura's living testimonies impacted our society's leaders in the US government.

                    Yes, by all means keep using rats. But let's open up the floodgates & get some human trials going (yes, I know, collectively we're working towards that goal). No, it won't be perfect. Sure, funding is an issue. But is it an impossible barrier to take down? Nope. Do we necessarily have to wait on the government? Nope. Where there's a will, there's a way.

                    Don't discourage those willing to try, unless undeniable hazards are existent. Then simply inform those willing... let them sign their consent forms... and let's see what happens. It may be disastrous, but it may be glorious. A lot of research has already taken place, and I like to trust that the research community knows the best directions to point us in. Don't you agree?

                    best regards,
                    ~ scott

                    p.s. please don't assume from this that I don't support organized, controlled, and structured research. I do 100%. I just think there's potential to be unleashed by those willing to let the rebel inside of them pave a course as well.
                    ____________________________________________

                    Very well said! [img]/forum/images/smilies/wink.gif[/img]

                    Gods speed for a cure~

                    Comment


                      Wise,

                      When will your rats be done with there experimental trial and the outcome of such a combination be know?

                      What is your opinion for an effective combination for a cure with this stradegy...

                      1) eliminate barries- (scar tissue, NOGO,)

                      2) replace lost neurons- (stem cells)

                      3) stimultate axonal growth- (GDNF, BDNF, Inosine, NT3, NGF, CNTF,replicons-genetic therapy)

                      4) remylination (OEC, Schwan cell or Oligodendrisits)

                      5) Snapitic genisis

                      6) Intensive PT

                      7) these are what i have found to be effective in my personal research within the last year or so, but i am sure there is more that you aware of..??..

                      Some of these have been around for decades. We need an effective combonation to restore function and accomplish a cure.

                      Gods speed for a cure,
                      Susan

                      thanks [img]/forum/images/smilies/wink.gif[/img]
                      ____________________________________

                      Wise,
                      you asked for our opinion, ???
                      thanks! [img]/forum/images/smilies/wink.gif[/img]

                      Comment


                        bump- [img]/forum/images/smilies/wink.gif[/img]

                        Comment


                          Susan, the combination therapies that have been reported to be synergistic include:
                          1. Cheng, et al. (1995). Peripheral nerve bridging plus fibroblast growth factor are more effective than individual therapies alone.
                            Xiao Ming Xu (2003). GDNF and chondroitinase markedly increase axonal growth into and out of Schwann cell channels implanted into hemisected spinal cord
                            Pearce, Bunge, et al. (2004). Rolipram (PDE-4 inhibitor), dibutyryl cAMP, and Schwann cell transplants together significantly improve locomotor recovery more than individual therapies.
                            Grumet, et al. (2004). Fetal neural stem cells (radial glial cells) plus the soluble cell adhesion molecule L1 synergistically improves axonal regeneration and locomotor recovery.
                            Wu, So, et al. (2004). Chondroitinase plus lithium chloride stimulates rubrospinal regeneration and improves recovery more than chondroitinase alone.

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