The TRIIM Trial (Supplemental Funds)

Intervene March 19, 2016 at 8:11 pm
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Project Description

The Thymus Regeneration, Immunorestoration, and Insulin Mitigation (TRIIM) clinical trial was formally launched at a kickoff event in Northern California on October 1-2, 2015. The aim of the study is to demonstrate thymus regeneration in 10 healthy 50-65 year-old men, and in the process to preliminarily define and refine the specific methodologies needed for optimal thymus regeneration. The trial is one year in duration, with magnetic resonance imaging of the thymus before and after the one year course of treatment to demonstrate and quantify thymic morphological regeneration. In addition, detailed immunological and physiological tests will be used to evaluate the success of the trial. Baseline blood samples were collected for later analysis on October 1st and 2nd, and baseline thymus scans were completed on October 2nd. Treatment with study medications then began on October 7th.

The trial involves two cohorts, the second of which is expected to begin treatment in February of 2016. As a result, the trial as a whole is expected to conclude in 2017. The trial is being conducted with the help of several collaborators at Stanford University.

A major objective of the trial is to not only demonstrate reconstitution of thymic structure and function, with restoration of the production of new T cells, but to also do so using methods that have minimal toxicity. So far, three months into the trial for the first cohort, we are seeing little toxicity, and no concerning risk factor responses, which we believe is due to the unique methodology we are applying. We are also learning a great deal about other aspects of the human physiological response to our trial protocol, including a number of things that bode well for the application of our treatment to many aspects of aging beyond the prevention of immune system aging.

Our trial may be the first FDA-approved clinical trial that specifically targets a core aspect of human aging, being approved and launched prior to the well-publicized and also path-breaking TAME study of Dr. Nir Barzilai, which aims to show anti-aging benefits of metformin.

So far, we are excited by the progress we have been able to make, and we are looking forward to the completion of this, our company’s first clinical trial, which we believe could be the beginning of some remarkably beneficial advances in human medicine.

Note: We are conducting our trial on a very low budget. This means that some potentially interesting tests cannot be run because they are presently beyond our financial reach. If you would like to contribute to the scope and power of the TRIIM trial, please send us a contribution for this project.  All of us at Intervene Immune are carrying out this trial pro bono, so 100% of your contribution will be spent on improving the knowledge we will be able to derive from this effort, which might allow us to help more people in the future — and conceivably, someday, maybe even you!

11 thoughts on “The TRIIM Trial (Supplemental Funds)

  1. Walter Crompton

    It ain’t much – just a token of our endorsement. When my company gets above water, I want to contribute more. Hooray for your great work!

    Reply
    1. Intervene

      Thanks a lot for your comment. We haven’t disclosed the full regimen for the TRIIM trial publicly, only to our trial volunteers, but we will say that we are using all FDA-approved drugs. The TRIIM trial and the regimen are part of a clinical study that aims to regenerate the thymus and immune system, while also controlling or mitigating common side effects of these medications, and a primary goal is to help firmly establish the appropriate dosing, length of time necessary, and other individual factors such as diet and health status that may influence its efficacy. But one of the very exciting aspects of the trial is that once these aspects are worked out (and they are being worked out now, i.e. as we conduct the trial, enroll more patients, and conduct more tests), physicians and patients can readily use this information and implement a similar treatment regimen for themselves.

      Reply
  2. Betty A

    I am female, age 63, and live in the Bay Area.
    I have had autoimmune hypothyroidism for at least 20 years.
    I would love to be in one of your trials.
    Please consider me.
    Thank you for your exciting research.

    Reply
    1. Intervene

      Thanks for your message! Our current TRIIM trial is only for men age 50-65, but we do care deeply about involving women in our future trials, and also curing autoimmune disorders, so we will add you to our contact list for consideration for enrollment in a future trial and general announcements as we move forward.

      Reply
  3. Anonymous

    I am 69 years and I am well aware that my age is a factor against me. But if you really want to see just what this study is capable of, please consider me for one of your trials. I have an autoimmune condition involving my thyroid. It is NOT Lupus. Other than that I am in good condition…..I feel like I am describing a “used car”!
    I would be so grateful if you would open your trials a bit more to include a more random group age wise and include me. I would be your ideal candidate dedicated to the study. I would even find a way to raise money for your study. I guess I am a bit desperate, but I would be grateful to be considered. My next birthday is in January of 2017. Think out of the box and hurry….. I am worth a try….Gratefully Yours.

    Reply
  4. Intervene

    Thanks a lot for your message. We greatly appreciate your interest in our trial. The sad truth is that, for the time being, all of our slots have been filled. However, we are definitely interested in expanding beyond the very healthy and tightly defined subjects we have enrolled in the present trial in order to explore both a broader age range and both men and womein in one or more future trials. Indeed, a key purpose of the TRIIM trial is to obtain reliable clinical data that will enable and inform many future clinical studies, and we are absolutely interested in curing autoimmune disorders similar to and including yours, although, in the short run, you may be able to find a more conventional solution to your thyroid problem.
    We are very sure that you are worth a try! However, we do have a limited budget, so our ability to help you depends on our ability to raise funds for additional studies. Therefore, if you can help us with fundraising, or make a contribution yourself, that could help us move closer to the day when we can announce a trial that you can be included in! In any case, be assured that we will do everything we can to raise the funding needed for additional trials and for achieving FDA approval of our current therapies, and that we encourage you to stay in touch so we can indeed give you a try when the time is right! All the best!
    PS: Note: one of the initial autoimmune diseases we’d like to cure is discussed here: http://interveneimmune.com/?ignition_product=t1d-project).

    Reply
  5. Dale

    As someone with an annoying auto immune disease and who’s been actively avoiding the accepted approach of down regulation off the immune system, I’d love to be able to retrain my immune system into realizing that it’s attacking the good guys. I’m in the southeast US and would be interested in any activity out this way. I’m right in the middle of your age range. But I’m not looking for only trial activity, but anything else (meetings, conferences, etc). This concept sounds really great. Let’s hope you don’t get bought out and your work buried. Did you know Nobel prize winners have excellent longevity? 🙂

    Reply
    1. Intervene

      Thanks a lot for your message and support! We will put you on a list of potential volunteers for future immune regeneration trials, and also let you know once we’re in a position to do more work with autoimmune conditions.

      Reply
    1. Intervene

      Hi Linda, thanks a lot for reaching out to us. We will put your name on a list of patient volunteers we have, and reach back out to you when it seems we’re in a position to help.

      Reply

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