The T1D Project

Intervene August 23, 2017 at 4:24 am
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Project Ends on December/31/2017
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Project Description

Intervene Immune is dedicated to human thymus regeneration and spin-off applications that arise from thymus regeneration, including the reversal or prevention of both transplant rejection and autoimmune disorders of all kinds.  Type 1 (juvenile) diabetes (“T1D”) is one autoimmune disease of particularly wide impact and notoriety.

In theory, T1D can be corrected using transplants of pancreatic islets, but there is no adequate technology yet demonstrated for performing such transplants without subsequent rejection of the islets.  Some current proposals involve barrier methods in which islets are transplanted in special capsules that let insulin out but don’t let antibodies in.  However, such chambers will inevitably break down or foul over time, making them unsatisfactory in the long run.  Other approaches involve suppression of the immune system, but so far, these approaches have not been adequate, and have the disadvantages of lifelong costs of immunosuppression and lifelong risks for infection, cancer, and other consequences of immune suppression.

That’s where we come in.  Intervene Immune has identified a thymus-based approach that could allow the body to recognize transplanted curative islets as “self” without more than transient and mild immunosuppression.  Rather than suppressing the immune system, our method works with the immune system, and in many cases may even substantially improve its performance.  The thymus is like a school that educates the cells of the immune system, teaching them  to combat foreign invaders and teaching it to recognize its host body (“self”) as something not to be attacked.  Our strategy is to “trick” the thymus into redefining transplanted islets as “self,” thus both accepting the transplanted islets and arresting the previous autoimmune attack on the patient’s own remaining islets.  This approach has the potential to permanently cure the disease without lifelong immunosuppression and the need for lifelong insulin injections.

The fundamentals were proven in 1990, and have been verified to work in many preclinical animal models, , yet no one has chosen to apply this method to human patients.  We think this lack of clinical application is egregious, and we intend to overcome it by carrying out the first clinical trial of intrathymic islet transplantation for the cure of type 1 diabetes in human patients, with your help.

Intervene Immune has arranged to acquire human pancreatic islets from a major Southern California institution that purifies these life-saving structures on a routine basis.  We have also obtained a statement of support from a skilled surgeon willing to carry out the islet transplantation for the study.  We have identified appropriate transplantation techniques, and obtained evidence of their safety and simplicity.  We have also acquired access to appropriate immunological and other testing techniques that should enable us to monitor patient progress and the success of the tolerance induction method we propose.

What we currently lack, and what you can help us with, is the funding to carry out the trial.  Our islet source, which has deep experience in human clinical islet transplantation, has enabled us to estimate the cost of treating just one young human patient, which, in round numbers, approximates $200,000, including the islets, the surgical facilities at a major California medical research institution, all trial medications and disposables, patient monitoring and counselling, specialized immunological and other testing, and trial personnel costs.  Although this cost is high, compared to 40 years of immunosuppression at roughly $15,000 per year (costing $600,000 all by itself), the cost of morbidity resulting from imperfect glucose control, and the cost of lifelong insulin injections, plus the cost of a limited lifestyle, the cost of a cure is still dwarfed by the cost of current treatments and the medical burden of the disease itself.  Plus, we believe the costs of a cure will go down as the cure is more widely deployed clinically.

We would like to be able to support an initial demonstration project on at least 5 appropriate young T1D patients, at a price tag of $1 million.  But of course, it would be even better to be able to demonstrate a cure on 10 young deserving patients, which would require $2 million.  Once these demonstrations have been achieved, we believe larger scale funding will become available to move beyond a demonstration project and into an FDA approval track that could save and improve the lives of well over 1 million US citizens and many more around the world.

This is, of course, only the beginning.  The same concept applies to all other autoimmune diseases, including multiple sclerosis, ankylosing spondylitis, lupus erythamatosis, and many more.  If you or someone you love is affected by any autoimmune condition, or by transplant immunosuppression, we ask for your support to enable us to help you.  In the end, it’s all up to you.  Please help us usher in a new era in medicine by clicking the link below, and sending us your best contribution.

Yours for a healthier, longer, more enjoyable, and more prosperous life,

Intervene Immune, Inc.

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