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Thread: ChinaSCINet Update

  1. #841
    Quote Originally Posted by KIM View Post
    Can we know their answer?
    They tell me that they are not ready. Wise.

  2. #842
    I have started thread with this topic on Exercise Forum:
    http://sci.rutgers.edu/forum/showthread.php?t=190450
    www.MiracleofWalk.com

    Miracles are not contrary to nature, but only contrary
    to what we know about nature
    Saint Augustine

  3. #843
    Quote Originally Posted by comad View Post
    Maybe I wasn't clear enough.
    I am asking about walking program details - Not about cells or surgery.
    I was reading all posts from Dr. Wise and his observation how they doing this walking (pulling knees to lock with ropes etc.) and that's good resource.
    There are some fine tweaks and details related to individual needs where PT with experience in this type of walking can help a lot answering to specific member questions. I have suggested to Dr. Wise to hook-up someone from Kunming with more time and specific knowledge to Exercise & Recovery forum.
    I know that language is barrier but simple q&a can be easily google-translated.
    Comad,

    Please understand that this is work of Dr. Hui Zhu and her colleagues. She recently retired (required due to age) from the Army General Hospital in Kunming and is in the process of moving to a private hospital in Kunming. The details of the training procedure that you are asking have not been published in English. I am not sure that they have been published in Chinese either. Dr. Zhu developed and applied these methods to thousands of patients. Yes, she has videos of individual patients but this is not the same as instructional materials.

    At ChinaSCINet, we have been doing our best to help them gather the evidence that intensive walking helps restore function and to introduce their method to other doctors. Over the past several years, I have brought many doctors and people from the community to observe. One member of CareCure will be spending time there to help translate and to make it easier for families to visit. We have even brought doctors from Kunming to Rutgers to speak in our Open Houses.

    At the present, there is nobody in Kunming with sufficient knowledge of English to answer questions of the type that you want to ask. I also want to suggest that this is asking a lot for any group to do and they will be criticized for doing so because their walking procedure is considered experimental. So, please be patient. I think that as soon as Dr. Zhu and her colleagues are settled in the new hospital and restarts her program, they will welcome visitors and perhaps people can help translate and transfer technology.

    Wise.

  4. #844
    Quote Originally Posted by Johnnie Walker View Post
    But Acorda does not have the patent in China too? so you can do it without Acorda?
    Johnnie,

    This is not a matter of having a patent in China. Nobody has a GMP (good manufacturing practice) source of chondroitinase that can be put into patients. Acorda (or whoever) must do a lot of work and invest a lot of money into making such a source of chondroitinase. They are not ready to do this. To my knowledge, nobody else is investing in manufacturing chondroitinase for clinical trial.

    It will be a multimillion investment and it will take years to establish such a GMP source. Chondroitinase is an enzyme made by Proteus vulgaris. To manufacture the drug, many strains of bacteria must be tested, characterized, and then used to manufacture chondroitinase that must be in turn tested in vitro and in vivo. After the best bacteria and manufacturing conditions are established, a master cell bank must be established that would allow the work to be reproduced. The drug must be formulated and each formulation must be tested and optimized.

    There are also many obstacles to approval for regulatory agencies to approve the clinical trials. First, proteus vulgaris is a common bacterium that participates in bladder infections. It is likely that many people with spinal cord injury have antibodies against chondroitinase. The FDA may well require this information before they will approve a clinical trial. Second, chondroitinase is an enzyme that is quite heat-sensitive and does not last long after injection into the spinal cord. FDA will require enzyme activity, stability, and degradation information. If it is injected into the spinal cord, they will want to know how it is degraded, how long it is active, and whether or not it causes any toxicity.

    So, it is not a slam-dunk and it will take time and money to get a source of chondroitinase that can be injected into the spinal cord.

    Wise.

  5. #845
    Quote Originally Posted by Wise Young View Post
    Johnnie,

    This is not a matter of having a patent in China. Nobody has a GMP (good manufacturing practice) source of chondroitinase that can be put into patients. Acorda (or whoever) must do a lot of work and invest a lot of money into making such a source of chondroitinase. They are not ready to do this. To my knowledge, nobody else is investing in manufacturing chondroitinase for clinical trial.

    It will be a multimillion investment and it will take years to establish such a GMP source. Chondroitinase is an enzyme made by Proteus vulgaris. To manufacture the drug, many strains of bacteria must be tested, characterized, and then used to manufacture chondroitinase that must be in turn tested in vitro and in vivo. After the best bacteria and manufacturing conditions are established, a master cell bank must be established that would allow the work to be reproduced. The drug must be formulated and each formulation must be tested and optimized.

    There are also many obstacles to approval for regulatory agencies to approve the clinical trials. First, proteus vulgaris is a common bacterium that participates in bladder infections. It is likely that many people with spinal cord injury have antibodies against chondroitinase. The FDA may well require this information before they will approve a clinical trial. Second, chondroitinase is an enzyme that is quite heat-sensitive and does not last long after injection into the spinal cord. FDA will require enzyme activity, stability, and degradation information. If it is injected into the spinal cord, they will want to know how it is degraded, how long it is active, and whether or not it causes any toxicity.

    So, it is not a slam-dunk and it will take time and money to get a source of chondroitinase that can be injected into the spinal cord.

    Wise.
    Seikagaku Corporation took the research reagent off the market because they are currently running clinical trials in Japan with Chondroitinase ABC under a generic name called "Condoliase" for disc hernia. They finished Phase 1 and 2 but have now requested a Phase 3 to begin. A Phase 2 has also been requested of the FDA here in the USA but the indication is strictly for disc hernia. Seikagaku Corporation won't run a clinical trial for sci as long as the disc hernia human trial is running because of the expenses. They would need financial help to run a CT for sci (in Japan anyway).

    http://clinicaltrials.gov/ct2/show/NCT00634946 SI-6603 is generic named "Condoliase" (Chondroitinase ABC)

    http://clinicaltrials.gov/ct2/show/NCT01282606

    Here's the structural formulation for "Condoliase": http://www.ama-assn.org/resources/do...condoliase.pdf
    Last edited by GRAMMY; 06-16-2012 at 02:55 PM.

  6. #846
    Quote Originally Posted by GRAMMY View Post
    Seikagaku Corporation took the research reagent off the market because they are currently running clinical trials in Japan with Chondroitinase ABC under a generic name called "Condoliase" for disc hernia. They finished Phase 1 and 2 but have now requested a Phase 3 to begin. A Phase 2 has also been requested of the FDA here in the USA but the indication is strictly for disc hernia. Seikagaku Corporation won't run a clinical trial for sci as long as the disc hernia human trial is running because of the expenses. They would need financial help to run a CT for sci (in Japan anyway).

    http://clinicaltrials.gov/ct2/show/NCT00634946 SI-6603 is generic named "Condoliase" (Chondroitinase ABC)

    http://clinicaltrials.gov/ct2/show/NCT01282606

    Here's the structural formulation for "Condoliase": http://www.ama-assn.org/resources/do...condoliase.pdf
    Grammy,

    Thank you very much for posting the information. As you know, the Seikagaku trial was completed and closed last year (2011). The trial tested their chondroitinase (SI-6603, condoliase), formulated and directed at the Japanese disc herniation market http://www.seikagaku.co.jp/english/i...u2012_2q_e.pdf.

    I use to work with Seikagaku, when they were interested in pursuing spinal cord injury. We trained a team from the company to do animal studies of the drug. The company decided not to pursue spinal cord injury as an indication and let go of the spinal cord injury team from the company.

    To my knowledge, that Seikagaku version of chondroitinase has not since been developed or tested for spinal cord injury within the company. Seikagaku recently licensed chondroitinase to Kaken Pharma, i.e. http://www.thepharmaletter.com/file/...-to-kaken.html.

    To obtain chondroitinase for spinal cord injury trials, we must have a GMP source of the drug, tested for safety and efficacy in administration to the spinal cord. To my knowledge, such a source is not available at the present.

    Wise.

  7. #847
    If that version of the chondroitinase abc was SAFE AND GOOD for disk hernia clinical trial , why that version is not good and safe enough for chronic spinal cord injury trial now?I am assuming in that clinical trial (phase 1 and 2 , etc. ), the safety of the drug has been validated, proven and established .
    Last edited by kz; 06-16-2012 at 05:18 PM.

  8. #848
    Quote Originally Posted by kz View Post
    If that version of the chondroitinase abc was SAFE AND GOOD for disk hernia clinical trial , why that version is not good and safe enough for chronic spinal cord injury trial now?I am assuming in that clinical trial (phase 1 and 2 , etc. ), the safety of the drug has been validated, proven and established .
    kz,

    Spinal cord is different from a herniated disc. A disc is a piece of connective tissue and it doesn't matter if some cells die in the disc after the injection. Injecting into the spinal cord injury completely different. You don't want to kill any cells. Of course, some investigators have used the Seikagaku chondroitinase to treat rodent spinal cords but you need formal safety pathological analyses of the spinal cord under GLP (Good Laboratory Practice) conditions. I don't know (and don't think) that Seikagaku has "validated, proven, and established" the safety of the drug for administration into the spinal cord of rodents and a non-rodent species, as required by the FDA.

    Wise.

  9. #849
    Dear Dr. Young ,
    Thanks so much indeed .

  10. #850
    Quote Originally Posted by kz View Post
    Dear Dr. Young ,
    Thanks so much indeed .
    You are very welcome.

    I don't mean to be discouraging but I want to emphasize that it takes much work and time to prepare any treatment for trial. That is one of the reasons why we are designating treatments of interest as early as we can so the necessary work be done to obtain essential data to get approval of the therapy for trial. it took us years to get umbilical cord blood cells and lithium ready for trial. We will need to do the same for the therapies that we want to take to trial in 2014. Please note that there is currently no GMP source of Cethrin or Muse cells either. Can you imagine what would happen if a tumor developed from the cells or chondroitinase made somebody worse? It would kill not only the therapy and also the careers of the investigators.

    Perhaps this is a good time to defuse assumptions that some people seem to be making. First, people should stop assuming that all we have to do is to inject some cells and drugs into the spinal cord. The therapies must meet the highest standards of safety and reliability in order to pass muster with the FDA and other regulatory agencies. Second, the therapies are not "mine". The therapies we choose to test are what my colleagues and I believe are the best promising and feasible therapies available for chronic spinal cord injury. Feasible means that the therapies are available, have undergone the necessary safety tests, and have a reasonable chance of showing efficacy. Third, we are still discussing the therapies for 2014. The only decision that has been made is that we are going ahead with the UCBMC and lithium phase 3. Fourth, we don't yet have funding for the planned phase 3 trials. People assume that the trials are going ahead with no funding. All our decisions are constrained by the availability of funds. We may have to delay these trials if we don't raise the funds.

    Wise.
    Last edited by Wise Young; 06-17-2012 at 12:23 PM.

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