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Possible Cures for Type-1 in the News (May)

Discussion in 'Research' started by joshualevy, May 2, 2019.

  1. joshualevy

    joshualevy Approved members

    Joined:
    Dec 30, 2008
    Messages:
    634
    This blog posting contains two different new items, with a short note on each:

    The One That Got Away

    The first article covers some work in Multiple Sclerosis (another autoimmune disease):
    https://www.painnewsnetwork.org/sto...tem-cell-therapy-reverses-ms-in-some-patients
    The article reports on a promising phase-II study on an incurable disease.

    The reason I'm discussing it here, is because this researcher was involved in very similar clinical trials on people with type-1 diabetes, many years ago. Those trials were the most successful ever done. People did not use injected insulin for years. You can read my previous blogging here:
    https://cureresearch4type1diabetes.blogspot.com/2010/11/snarski-confirms-burts-phase-i-results.html
    or more generally here:
    https://cureresearch4type1diabetes.blogspot.com/search/label/Burt

    But years ago, this researcher switched from Type-1 Diabetes to Multiple Sclerosis. Why? Because of safety trade offs. One researcher told me that the T1D version of this treatment would likely have an expected death rate of 1%. In actual studies (on people!) the death rate was about 1 in 65. For a disease like Type-1, that is not acceptable. But for a disease like Multiple Sclerosis (which can lead to death after 10-30 years, and which often has a much bigger quality-of-life impact), maybe it is acceptable.

    So, while I'm sad that the type-1 world will not benefit from this research (at least not in the short term), I am happy that our disease is not so dire that a treatment like this is viable.

    Phase-II T-Rex Trial Reports Unsuccessful Primary Results

    On a completely different note, the T-Rex Trial reported its primary end point. For background, you can read my previous blogging about this research here:
    https://cureresearch4type1diabetes.blogspot.com/search/label/Polyclonal Tregs

    A quick summary of this treatment is as follows: remove one specific type of T regulator cell (called "CD4(+)CD25(+)CD127(lo)") from a person with type-1 diabetes. Grow them out so you have about 500 times more, and then put them back in the same person. Since regulatory T cells naturally regulate the body's immune system, and the patient now has more of them, the hope is that they will prevent the autoimmune attack which causes type-1 diabetes.

    In February, the T-Rex trial reported its primary end point results at 1 year, and they were unsuccessful. The exact quote was:
    no improvement in the primary endpoint of preservation of C-peptide levels vs. placebo at 1 year was observed at the group level (using the standard mixed meal tolerance test)​

    Of course, the company is hopeful that they can find some good news by reanalyzing the data, looking at subgroups, etc. but I'm very dubious about this. In the type-1 diabetes research that I follow, I have yet to see this kind of reanalysis yield a success after the primary analysis was unsuccessful. The trial is scheduled to collect data for two years, so there should be another update in about a year.

    This information all comes from a corporate press release. There was no mention of a research paper.

    Press Release: https://www.caladrius.com/press-rel...l-of-clbs03-for-recent-onset-type-1-diabetes/
    News coverage: http://www.evaluate.com/vantage/articles/interviews/caladrius-refuses-give-tregs-diabetes

    Joshua Levy
    http://cureresearch4type1diabetes.blogspot.com
    publicjoshualevy at gmail dot com

    All the views expressed here are those of Joshua Levy, and nothing here is official JDRF, JDCA, or Bigfoot Biomedical news, views, policies or opinions. In my day job, I work in software for Bigfoot Biomedical. My daughter has type-1 diabetes and participates in clinical trials, which might be discussed here. My blog contains a more complete non-conflict of interest statement. Thanks to everyone who helps with the blog.
     
  2. rgcainmd

    rgcainmd Approved members

    Joined:
    Feb 6, 2014
    Messages:
    1,366
    Thanks, Joshua.

    I haven’t started holding my breath for a cure, and I suspect I never will.
     

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