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Your Thoughts on China's Stem Cell Educator Therapy Clinical Trial

Discussion in 'Research' started by Turtle1605, Dec 9, 2013.

  1. Turtle1605

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    I saw on the clinicaltrials.gov website that they are enrolling individuals (including children as young as 6 years old) in the stem cell educator therapy. Of course, one would have to travel to China, which is a bit prohibitive. But let's say it was no problem for me to take my son to China...would you participate in the trial? I just wondered what some of your personal thoughts are...the pros and cons of enrolling your child in this type of trial. Personally, I would be concerned that it wouldn't work (which would be heartbreaking) and I would be concerned that it may lead to some kind of worse medical condition 10 years from now (some days I wonder if there is anything worse...although I know there is). I also wonder if it would prohibit my son from being eligible for something that may truly be a cure in the future.

    I have a lot of what if's going on in my head and science is not my strong point so I was wondering all of the things you would consider if you were a parent of a young child with this opportunity. Any thoughts?


    http://clinicaltrials.gov/ct2/show/...2013&lup_s=07/01/2013&lup_e=12/08/2013&rank=3
     
  2. sparty87

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    I would wait a few years... There are a number of adult trials already...

    1. I would wait until we know something about long term follow-ups on the adult patients from his original trial.
    2. I would wait until we know about the outcome of the trial in Spain, where multiple treatments were given, months apart.
    3. I would wait until we know something about the findings of Mark Atkinson's in vitro study. It was suppose to have wrapped up in Aug.

    If good results are obtained in the above, I would hope a US trial would be funded. The pressure on the government and T1D charities would be overwhelming. I can't see flying my daughter to China to participate in a trial. D sucks, but it is not an acute fatal illness that demands a risky unproven immediate treatment.
     
  3. joshualevy

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    I think it is almost impossible to speculate about something like that. These are the most personal decisions about health, and we all think about risks and rewards and our own children very differently.

    Here are a bunch of disjoint and random thoughts:

    • I don't see any obvious reason why this treatment should effect adults and children differently, so I think results in adults will be applicable to children (both safety and effectiveness).
    • There are many reasons to think that this treatment is likely to be safe (as compared to a drug or genetic therapy or cellular therapy). Now that's not a reason to rush in or skimp on safety, but I would be less worried about this treatment, than your average new drug (for example). The fact that nothing new ends up in your body, for example, seems like an extra layer of safety that is not there for most other therapies.
    • Right now, the results of this therapy are lower insulin use, and (hopefully) fewer long term complications. That's good, but it's not yet a cure, so you're not trading off unknown effects vs. possible cure, you are trading off unknown effects vs. less insulin and hopefully less complications, but no saying how much less.
    • As for future trials, you can look at the clinical trials records at clinicaltrails.gov, and see. Some trials do exclude people who have had previous experimental treatments, so only exclude people who have had related treatments, and some don't exclude any previous treatment. I don't know how many do what, and (in any case) we don't know what will happen in the future. But I would expect that being part of a Educator trial now, will exclude you from some (maybe all) Educator trials in the future.
    • Although being in one trial may stop you from being part of another trial, it is very unlikely to stop you from getting a treatment, once that treatment is approved. It's very, very rare where someone says, you got treatment X years ago, and now treatment Y is approved, but we will not give it to you because you tried X long ago. I'm sure it's happened on rare occation, but very rare.
    • The "what if there's a bad effect in 10 years" problem is always there with any treatment. Even once the treatment is approved, there are often little knowledge of 10 year effects, and none of 20 year effects. That is true for all new treatments.
    • Waiting for more clinical trials to complete is always prudent. You will have more information then. But even after those studies are done, it will still be prudent to wait for still more. It is always a trade off.
    • Dr. Atkinson's work is designed to try to find out why the treatment works. People are nervous, because no one (except maybe Dr. Zhou) has a good idea about why it works. In one sense, knowing why it works would help a lot, both in making the treatment more effective, and making people more comfortable with the treatment. But on the other hand, people used Aspirin for decades before anyone had any idea why it worked. And if someone cured type-1 without knowing why it worked, that would not bother me at all. (In my humble opinion) the real purpose of Dr. Atkinson's work, is to make JDRF comfortable enough to put money into human trials. That's a useful goal in itself, but it's not really safety related.
    • A lot of people want to see what happens in Spain, because China has a bad reputation, and they are more comfortable with results from Spain. I'm not saying this is right or wrong, or I agree with it or not, but it seems to be a common sentiment, among people I talk to.

    Joshua Levy
     
  4. adjusting dad

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    We have started the process to travel to China and do this study with our 8 year old. The process seems safe, but I would love to have any additional thoughts.

    I would greatly prefer to do the study here, or even in Spain.

    I would love to know more about why there is not trial location in the US. I've asked Dr. Zhao, but I don't have a response yet.

    I also want to know more about the 150 that have had the treatment worldwide.

    The original study only had 15 (with control). I would like to see more data before giving final go ahead.

    Also (especially Joshua), is there any reason the Tregs could get "mis-educated" and all of a sudden start turning on other organs?
     
  5. joshualevy

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    For interested people, here is the JDRF abstract for the work they funded in Florida, which is related to Dr. Zhao's Stem Cell Educator but done in mice:
    http://onlineapps.jdfcure.org/AbstractReport.cfm?grant_id=38534&abs_type=LAY

    This grant runs until end of February 2014, but I don't know how or when any results will be published.

    Here is the Background/Rationale for this grant:

    The findings from the Cell Educator clinical trial not only demonstrated the feasibility and safety of this form of therapy but quite remarkably, noted that T1D patients achieve improved metabolic control that (thus far) has lasted for many months following a single treatment. Notably, this trial provided intriguing evidence that the treatment may lead to either regeneration of islet ß cells, or a restoration of existing ß cells to produce insulin; this, based on elevations (post-therapy) in Cpeptide production. Taken collectively, this study demonstrated the safety and therapeutic efficacy of Cell Educator therapy in Chinese T1D patients.​

    And here is another sentence from the project description:
    With any "breakthrough" discovery, an important follow-up phase is one involving independent scientific validation. This is the purpose of this SRA; through collaboration with the inventor of this technology, seek independent validation of early key issues.​

    Joshua Levy
     
  6. sszyszkiewicz

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  7. bijanrad

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    Hello everyone; my daughter, 17 years old was just diagnosed with type one diabetes. We hear promising result from Stem Cell educator therapy. We plan to take her to China for first treatment next week. Could you please comment specially anyone who has had this procedure ... Safety , prognosis....How about Josh Levy? could you please comment? Thanks
     
  8. sszyszkiewicz

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    Wishing your daughter all the best, and also a heart-felt thank you. If they allow, let us know how it goes!
     
    Last edited: Feb 25, 2014
  9. Christopher

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    I would want to look at the Informed Consent Form first. And no, I am not flying my daughter all the way to China for a trial. It is not like you are going there for a cure. If this trial does end up helping to develop a cure (which I doubt it will), I am fine with waiting until it is approved by the FDA and is available to everyone. But that is just me.
     
  10. Christopher

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    So you are taking your daughter there next week and you don't know about the safety of the procedure? Wow. Do you know exactly what will be done to your daughter during the clinical trial? Have you seen the Informed Consent Form?
     
  11. StillTypeI

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    I'm curious what happened to the two posters, adjusting dad and bijanrad. Both stated that they were in the process of going to China, this was back in February. What was the outcome?
     
  12. bijanrad

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    It has been a month since we are back from China. We are closely monitoring the fasting sugar level and the insulin intake . We have not seen any improvement thus far . But we are told we need to wait three months. All fingers crossed! If we see improvement such as C peptide level and fasting blood sugar level, we will go back for 2nd and third treatment. Will keep you folks posted.
     
  13. sszyszkiewicz

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    Thanks!

    is it part of the protocol to only get a 2nd or 3rd treatment if things improve or is that just your decision?

    Do they have you checking the c peptides at your local hospital?
     
  14. Christopher

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    Interesting. Can you share your experiences with the clinical trial, what happened during the trial, how did your child handle it, what were their thoughts and feelings about participating in it. Is your Endo doing the follow up tests?
     
  15. StillTypeI

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    Details, it's all about the details! Can you please share them with us?
     
  16. joshualevy

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    I would also like to hear the details. Posting something here would be great. Also, CWD has the new "chat" feature. Are you willing to set up a time when you would be available on chat, so people could ask you questions a little more interactively? I would be happy to set up a new chat just for this dicsussion (it's easy). You would just scheduled a time to be available.

    Joshua
     
  17. bijanrad

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    Be glad to share details. The medical staff in were great. Very professional and knowledgeable. Dr Zhao and a Registered Nurse ( RN) had travelled to China to meet us and two other families who had travelled from Spain. These two families could not receive treatment in Spain as their children were on 4 and 3 years old and would not meet the age limit in Spain. The procedure took about nine hours. Multiple immunological and serum tests were performed during and after the procedure. The hospital setting is old but clean. Our 17 year old had no complaint during and after the procedure. As stated earlier, we remain hopeful that the treatment will lead to favorable results.

    As for "chat" , be glad to participate. We are in Pacific time zone . I can make myself available on Friday 11th, at 7:30 pm or Saturday morning at 10:00 to 10:30 Los Angeles time . Please let me know so I can join the chat .
     
  18. joshualevy

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    Aaarrg. I can't do either of those times. Sorry. On the other hand, if others are interested, you can just click on the "new chat" button at the bottom of the screen, and set up your own chat. You don't need me.

    Also, if you are comfortable publishing information, can you tell us what your child's diabetes was like before treatment? When was diagnosis? How much basil insulin is used on an average day? What Insulin:carb ratio, and insulin:BG adjustment ratio? Finally, did they tell you anything about your child's C-peptide generation prior to treatment? Did they say how much C-peptide was generated while fasting, or in a response to a meal, or both? Total insulin used per day and A1c might also be interesting. This is the kind of data that I'd like to compare before treatment, after treatment, and months after treatment.

    Joshua
     
  19. sszyszkiewicz

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    How about Friday the 11th at 7:30 PM PDT.??
     
    Last edited: Apr 11, 2014
  20. StillTypeI

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    I'll be there!
     

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