Thread: ChinaSCINet Update

  1. #2191
    and maybe using HuCNS-SC stem cells to recover sensory function below the level of injury

    http://www.spinalcordinjuryzone.com/news/13466/stemcells-inc-initiates-phase-2-clinical-trial-cervical-spinal-cord-injury

  2. #2192

    Norway trial

    Quote Originally Posted by Wise Young View Post
    The trial is being planned for China, India, Norway, and the United States. We hope to start the trial in 2015 but much depends on getting the permission from the regulatory agencies and our efforts to raise money for the trials. In China, we have to process the cells and have been working on validating the centers that have agreed to do this. There are too many unknowns to be able to predict when the treatment will be available in the United States as an approved therapy. I am aiming for 2018 but this depends on many unpredictable factors. Wise.
    Dr. Young how would I go about applying to participate in the Norway trials do you have the name of the hospital or doctor planned for the trial?

  3. #2193
    It is still being planned. We will post the info when available.

  4. #2194
    Dr. Young, are there any videos available of the patients who were able to walk after treatment? And what are the thoughts on combining the treatments of the olfactory stem cells with the umbilical stem cells? They appear to do two different things and working together might achieve better results, or maybe not?

    Thanks for all your encouraging work.

  5. #2195
    mwalshusa,

    Sorry. There are no public videos of the patients who are walking after treatment. Some will be made available after publication of the paper. We are still trying to get the paper published.

    Regarding combination of umbilical cord blood mononuclear cells and olfactory ensheathing glia, we have discussed this. My laboratory has long done olfactory ensheathing glia transplants and we are planning to do combined olfactory ensheathing glia (OEG) and mononuclear cells transplants in animals. Actually, I should point out that most OEG transplants already involve a combination of cells. For example, most OEG transplants include neural stem cells and probably meningeal fibroblasts present in the olfactory bulb.

    One of the reason why we have not seriously considered OEG cells in our clinical trials is the difficulty of obtaining such cells. Hongyun Huang has been transplanting OEG from aborted fetuses for many years but, as pointed out before, these cells are not immune-compatible with the recipient and are likely to be immune-rejected within several weeks after transplantation. At present, there are two sources of immune-compatible OEG cells. The first is the autologous olfactory bulb (which was reported in the Polish study being discussed). The second is the lamina propria of the olfactory epithelium from the patient.

    Carlos Lima and his colleagues transplanted olfactory mucosa into the spinal cords of over 160 patients with chronic spinal cord injury. The recovery of the patients have been modest. Geoffrey Raisman has been working on growing OEG cells from olfactory mucosa for several years. These have been transplanted into several patients and reported recently. I don't know whether Geoffrey is planning further clinical trials.

    Removing an olfactory bulb is not a trivial operation. The olfactory bulb is located at the base of the brain and is responsible for a very important function, i.e. smell. While the paper indicates that removal of one olfactory bulb appears not to have a significant deleterious effect on the olfactory function of the patient, this is only one patient and more experience is needed. The procedure also requires a local laboratory that is qualified to culture and expand the olfactory ensheathing glia from the olfactory bulb.

    In my opinion, it will be difficult to get regulatory approval for olfactory ensheathing glial cell expansion for a large-scale clinical trial in the United States or European Union countries. Much safety data will be required for approval by the US FDA (Food and Drug Administration), EMA (European Medicine Agency), cFDA (China Food and Drug Administration) for phase I/II trials.

    Wise.

    Quote Originally Posted by mwalshusa View Post
    Dr. Young, are there any videos available of the patients who were able to walk after treatment? And what are the thoughts on combining the treatments of the olfactory stem cells with the umbilical stem cells? They appear to do two different things and working together might achieve better results, or maybe not?

    Thanks for all your encouraging work.
    Last edited by Wise Young; 10-29-2014 at 06:22 AM.

  6. #2196
    Quote Originally Posted by Wise Young View Post
    In my opinion, it will be difficult to get regulatory approval for olfactory ensheathing glial cell expansion for a large-scale clinical trial in the United States or European Union countries. Much safety data will be required for approval by the US FDA (Food and Drug Administration), EMA (European Medicine Agency), cFDA (China Food and Drug Administration) for phase I/II trials.

    Wise.
    This troubles me to no end. Say this procedure shows large scale benefits how could they leave people in chairs "for there own good"? just awful and not right in my opinion..

  7. #2197
    Quote Originally Posted by Eric.S View Post
    This troubles me to no end. Say this procedure shows large scale benefits how could they leave people in chairs "for there own good"? just awful and not right in my opinion..
    Please note that I did not say that it would be impossible. I just said that it would be difficult. I believe it would be difficult for the following reasons:

    1. The study did not show "large scale benefits" in many patients or even significant functional benefits in one patient.

    2. Transplantation of expanded cells, even from oneself, carries significant risks. The US FDA and most regulatory agencies will require demonstrations of the safety of such transplants, e.g. that it does not form tumors.

    3. The procedure for removing one olfactory bulb is not trivial.

    Let me provide more details on number 2. Expansion of cells means to grow the cells in culture. When one grows cells in culture, one is putting the cells into cell culture medium that contains growth factors, cytokines, and other factors that stimulates the cells to grow. If the culture or tissue contains cells that tend to grow out of control, the cells may form tumors when transplanted. Embryonic stem cells are known to produce tumors when transplanted. That was why Geron was required to do nearly 4 years of animals studies to show the safety of the cells. In the end, the FDA required Geron to show that less than 1 out of billion cultured cells show characteristics of being pluripotent stem cells. Both large and small animal studies will be required.

    One good thing is that several groups already have experience with transplantation of olfactory lamina propria to the spinal cord. Carlos Lima transplanted lamina propria into the spinal cord of over 160 patients, apparently safely. However, experience is a two-edged sword. For example, one of Carlos Lima's patients developed a tumor in the spinal cord about 10 years after transplantation. So, the FDA will be looking for reassurance that this would not happen.

    Expansion is also a relatively term. I have heard that the Chinese FDA will regard a culture that has undergone less than 8 passages to be minimally manipulated. If so, that is great because it suggests that some expansion of the cells is possible with minimal regulations. I don't know how many passages was used to grow the cells from the olfactory bulb.

    Note that mononuclear cells from umbilical cord blood were minimally manipulated in the ChinaSCINet trial. We did not grow them in any way. We obtained from umbilical cord blood units that would be transplanted into patients to replace bone marrow. The cells are sterile, tested HIV and other potential infecting agents, and isolated from the cord blood using well-established and standardized procedures. They fulfill the criterion for minimally manipulated cells.

    Wise.

  8. #2198
    Senior Member Tbone57's Avatar
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    Quote Originally Posted by Wise Young View Post
    Please note that I did not say that it would be impossible. I just said that it would be difficult. I believe it would be difficult for the following reasons:

    1. The study did not show "large scale benefits" in many patients or even significant functional benefits in one patient.

    2. Transplantation of expanded cells, even from oneself, carries significant risks. The US FDA and most regulatory agencies will require demonstrations of the safety of such transplants, e.g. that it does not form tumors.

    3. The procedure for removing one olfactory bulb is not trivial.

    Let me provide more details on number 2. Expansion of cells means to grow the cells in culture. When one grows cells in culture, one is putting the cells into cell culture medium that contains growth factors, cytokines, and other factors that stimulates the cells to grow. If the culture or tissue contains cells that tend to grow out of control, the cells may form tumors when transplanted. Embryonic stem cells are known to produce tumors when transplanted. That was why Geron was required to do nearly 4 years of animals studies to show the safety of the cells. In the end, the FDA required Geron to show that less than 1 out of billion cultured cells show characteristics of being pluripotent stem cells. Both large and small animal studies will be required.

    One good thing is that several groups already have experience with transplantation of olfactory lamina propria to the spinal cord. Carlos Lima transplanted lamina propria into the spinal cord of over 160 patients, apparently safely. However, experience is a two-edged sword. For example, one of Carlos Lima's patients developed a tumor in the spinal cord about 10 years after transplantation. So, the FDA will be looking for reassurance that this would not happen.

    Expansion is also a relatively term. I have heard that the Chinese FDA will regard a culture that has undergone less than 8 passages to be minimally manipulated. If so, that is great because it suggests that some expansion of the cells is possible with minimal regulations. I don't know how many passages was used to grow the cells from the olfactory bulb.

    Note that mononuclear cells from umbilical cord blood were minimally manipulated in the ChinaSCINet trial. We did not grow them in any way. We obtained from umbilical cord blood units that would be transplanted into patients to replace bone marrow. The cells are sterile, tested HIV and other potential infecting agents, and isolated from the cord blood using well-established and standardized procedures. They fulfill the criterion for minimally manipulated cells.

    Wise.
    I understand the concern regarding the formation of tumors, I don't think many people would opt to have cancer in exchange for paralysis. My question is, are there any documented cases of tumors in any of the trials going on, other than the Lima patient.

  9. #2199
    In phase 2 umbilical cord blood mononuclear cells the results was that is safe and some persons become from asia A to asia c.. so in third phase which is the goal tha you want to achieve?

  10. #2200
    Quote Originally Posted by athanasios View Post
    In phase 2 umbilical cord blood mononuclear cells the results was that is safe and some persons become from asia A to asia c.. so in third phase which is the goal tha you want to achieve?
    That's not how it works. You will get most answers from page 205 onwards in this forum thread. It will save you asking the same answered questions many of us did when we came here.

    I can't say if there was any change on the ASIA scale, as they rely on sensory and motor function. The trials had positive results on locomotor function which is slightly different. I'm not qualified to answer this, but the results will be officiallt published by the end of the year. Hope this helps.

    Regards

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