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Zhao Upgrades His Clinical Trial to Phase-II‏

Discussion in 'Research' started by joshualevy, Oct 28, 2012.

  1. joshualevy

    joshualevy Approved members

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    I've previously blogged on Zhao's work here:
    http://cureresearch4type1diabetes.blogspot.com/search/label/Zhao
    He published his phase-I results in January 2012, and in July, he changed the basic nature of his clinical trial record from phase-I/II to phase-II. Change a trial from I/II to II is uncommon, but it does happen. (The more common thing is to create a new clinical trial for the phase-II study.) But the whole point of a I/II trial is that it can turn into a II if things go well. In January, Dr. Zhao published data on 12 treated patients and 3 placebo patients, but the clinical trial record was for 100 people, so the remaining 80+ people (I assume) will be his phase-II trial.
    Notice that it took him only 6 months to "turn around" from publishing his phase-I study to starting the phase-II study. That's quicker than most research I follow.
    The trial record was also updated in Augest and October, so if you group together all the changes made, here is a summary of the changes:

    • Phase goes from 1 to 2.
    • A second trial site has been added. In addition to China, patients in Spain can enroll at Hospital Universitario Central de Asturias.
    • Purpose goes from "Safety/Efficacy" to "Efficacy" Study.
    • The study was expected to complete in 2012 now is expected to complete in September 2014.
    • Sponsor goes from University of Illinois to Tianhe Stem Cell Biotechnologies (Zhao's company).
    • Trial design went from single blind to open label, and
    • There is no mention of a placebo or control group.
    Also, Tianhe (Zhao's company) has also started a separate clinical trial aimed at using this same technology to cure/treat Alopecia Areata, which is another autoimmune disease involving T-cells. The trial is being run in China.


    Finally, another researcher (Dr. Mark Atkinson) has been funded by JDRF for a year to test Dr. Zhao's Cell Educator "ex vivo" (not in living organisms, but in tissue samples or similar). The goal is to independently verify parts of Dr. Zhao's results. You can read details here:

    JDRF "lay abstract": http://onlineapps.jdfcure.org/AbstractReport.cfm?grant_id=38534&abs_type=LAY


    Discussion

    From my point of view, there is both good and bad news here. Going from single blind to open label is a step backwards, in my mind. Not having a placebo group is also going the wrong direction. On the other hand, another site, more people, and an end point in the near future are all good things.

    Corporate web site: http://www.tianhecell.com/
    Clinical Trial Record: http://www.clinicaltrials.gov/ct2/show/NCT01350219

    Joshua Levy
    All the views expressed here are those of Joshua Levy, and nothing here is official JDRF or JDCA news, views, policies or opinions. My blog contains a more complete non-conflict of interest statement.
    Clinical Trials Blog: http://cureresearch4type1diabetes.blogspot.com
    Cured in Mice Blog: http://t1dcuredinmice.blogspot.com/
     
  2. carbz

    carbz Banned

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    Josh, from my own perspective I am mainly curious to know what the status of is of the previous patients that had already gone through the procedure. Dr Zhao has not made mention of this anywhere to my knowledge. I think most people would at least like to know whether the infusion still has lasting results. I hope they can continue moving forward and not get stuck in the Faustman "we need funding" mode.
     
  3. Ed2009

    Ed2009 Approved members

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    For what I see in their website, there's a publication of the results:

    http://www.tianhecell.com/uploads/BMCMedicine.pdf

    Where it shows 3 groups (page 4/11): A, with 6 patients with residual islet function (c-Pep from 0.12 to 0.64), B, with 6 patients with 0.01 c-Pep (no islets left), and 3 patients as control group (c-Pep from 0.3 to 0.56).

    Then you got the graphs in page 5/11:

    Graph A: Shows fasting c-Pep: Group A and B increased it. A went over the normal limits, group B almost there. Control group C no changes.

    Graph B and C: After a 75 grams Oral Glucose Tolerance Test; c-Pep is measured fasting, then 75 grams of fast carbs is ingested, c-Pep is measured in time intervals, the maximum c-Pep activity normally shows up after 90-120 minutes. Here shows the 120 minutes level.

    Graph B is for group A (residual activity), after 12 weeks. The c-Pep levels are over the minimum fasting for non-D people, the 2 hours one are not normal (say 5), but little less than half of it (2 avrg.).

    Graph C is for group B (no residual activity), after 40 weeks. Although the maximum is near the normal fasting levels, the increase from before the treatment is exponential, which -and this is a personal opinion-, whilst not a cure, should make D-management way easier than usual, not to say the impact in hypos and D side effects.

    I did not go through the immune analysis as I do not understand its nuances.

    However, I'll risk here a comparison of the results of table 1 and 2. If anyone thinks this is not a fair comparison and I'm missing some point, please say so, as I do not want anyone misled by these numbers:


    ---------------------Before-----After 12 w
    Group-----Patient----c-Pep------c-Pep-------Diff %

    A----------1----------0.3--------0.56------- 86.7%
    A----------2----------0.56-------0.98------- 75.0%
    A----------3----------0.12-------0.54------- 350.0%
    A----------4----------0.636------1.10------- 73.0%
    A----------5----------0.18-------0.52------- 188.9%
    A----------6----------0.18-------0.78------- 333.3%

    B----------7----------0.01-------0.25------- 2400.0%
    B----------8----------0.01-------0.11------- 1000.0%
    B----------9----------0.01-------0.28------- 2700.0%
    B----------10---------0.01-------0.43------- 4200.0%
    B----------11---------0.01-------0.11------- 1000.0%
    B----------12---------0.01-------0.12------- 1100.0%

    C----------13---------0.37-------0.41------- 10.8%
    C----------14---------0.55-------0.38------- -30.9%
    C----------15---------0.3--------0.35------- 16.7%



    And here starts my list of missing data, the one I wonder why is not there:

    - Same table as table 1 but with the values at 24 and 40 weeks.
    - Group 1 data for 40 weeks.

    Again, if this is only even partially so, I think this trial takes is ahead of all of the ongoing ones.
     
  4. pdx_dc

    pdx_dc Approved members

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    yes, he is in need of funding, and trials are stalled or delayed for want of funding

    Hi Carbz,

    Yes, his trials are delayed or stalled because of want of funding, he himself emailed me about it. I posted his email in my other posting.

    I think we should really get together as a group and do fund raising - from public and from institutions..

    He is also trying to get a trial started here in the US.

    Too bad, he doesn't have a strong following like Dr. Faustman does.

    I cringe when I see him expanding to "hair loss" clinical trials - when I feel he has something important for T1D :-(
     
  5. sparty87

    sparty87 Approved members

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  6. StillTypeI

    StillTypeI Approved members

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  7. Ed2009

    Ed2009 Approved members

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    Conflict of Interest

    On Atkinson's experiment it says (Sparty87 link):

    Quote:
    " Objective
    Seek independent validation of early key issues with Cell Educator therapy as follows: "What changes does Cell Educator Therapy impart on leukocytes?" "Are the observed effects with Cell Educator Therapy specific or unique to patients with T1D (versus healthy controls)?" "Does allogeneic human cord blood provide specific (and beneficial) properties in the Cell Educator?"
    "

    But as StillTypeI very well points out, Dr. Atkinson belongs to the board of Dr. Zhao's company.

    Now, kinda conflict of interest here, or is it just me? Now, look at my previous post and I'm enthusiastic about Zhao's results, but I'd hate to see them tarnished by an "independent validation" of them done by his buddy!
     
  8. sparty87

    sparty87 Approved members

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    Still no news, as far as I can find, on Atkinson's in vitro study or any preliminary news from the study in Spain, where multiple treatments were being administered. Zhao has started a new trial, this time with Chinese children, single treatment, testing for autoimmunity markers after 90 days and c-peptide followup for 2 years.


    http://clinicaltrials.gov/ct2/show/study/NCT01996228
     

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