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New Clinical Trials Aim to Address Challenges of the Immune System

(November 2017) Overcoming the significant challenges of the immune system is absolutely critical in developing a biological cure for this disease, which is why it is now the subject of increasingly intense focus at the Diabetes Research Institute. While islet transplantation has already changed the lives of those with type 1 diabetes (T1D), only a small percentage of people can benefit from this cell replacement therapy due to various hurdles, including the need for lifelong immunosuppression. These harsh drugs cause unwanted side effects and, while effective at preventing the body from rejecting the transplant, do not address the underlying disease process that triggers the attack on the insulin-producing cells.

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“The widespread application of islet transplantation for type 1 diabetes will be a limited approach we can offer until there are less toxic immunosuppressive regimens, more robust ways of inducing immune tolerance to the transplanted islets, and, ultimately, the development of strategies to block autoimmunity,” explains Camillo Ricordi, M.D., director of the Diabetes Research Institute (DRI). “If we can ensure that new islets will not be destroyed by autoimmune disease, then we can even think about regenerating insulin-producing cells from the patient’s own tissues.”

USING SAFER METHODS

Scientists have learned a great deal about the immune system thanks to decades of experience in clinical islet transplantation and other diabetes research trials. Now, they are developing novel approaches that are designed to be safer and more effective in tackling the immune system head on.

The idea behind these new immunotherapies is to use naturally occurring molecules and low-dose agents to correct autoimmunity and halt the attack on the insulin-producing cells. Some of the DRI’s most innovative strategies aim to better regulate the immune system and target the multiple immune pathways that are implicated in T1D.

At the DRI, many promising initiatives are ready to be tested in patients. Recently, DRI scientists received approval from the Food and Drug Administration (FDA) to proceed with several new clinical trials, while others are pending approval and funding.

“It is an exciting time in diabetes research because we will have five clinical trials progressing in parallel at the DRI, which is unprecedented in our history,” said Dr. Ricordi. “We are directing our new clinical research efforts towards the challenge of immune tolerance, reversal of autoimmunity and islet regeneration. We’ve built a network of like-minded scientists committed to eradicating T1D; we’re focused more than ever on linking all these centers with us as we hone in on the immune system as a central player on that stage.”

The five clinical trials Dr. Ricordi refers to are:

DIPIT (Diabetes Islet Preservation Immune Treatment): The DIPIT study will test an innovative combination of several clinically approved agents that target multiple immune pathways. The trial will assess its effectiveness for halting the immune system attack, preserving the remaining islet function, and, possibly, giving the body a chance to recover and regenerate its own insulin-producing cells.

Low-dose IL-2 in Established T1D: Interleukin-2 (IL-2), is a protein produced by the body that plays a key role in immune system function. Low-doses of IL-2 have already demonstrated effectiveness in correcting autoimmunity in patients with other conditions. The trial will test the effects of using low-doses of IL-2 in type 1 diabetes.

POSEIDON (Pilot Study of Omega-3 and Vitamin D High Doses in T1D): Several scientific reports have suggested that the use of high-dose omega-3 and vitamin D, both of which have known anti-inflammatory properties, may offer a potential beneficial effect on autoimmune conditions, like type 1 diabetes. Pending FDA-approval, the POSEIDON study will evaluate the effects of this therapy in those with T1D.

Intraocular Islet Transplant Trial: This study will test the safety and efficacy of the eye as a potential site for islet transplantation, and determine whether immune tolerance can be achieved locally within the site or systemically by retraining the immune system.

BioHub Trial - Islet Transplantation onto the Omentum: As part of its ongoing trial to test a new site for a DRI BioHub platform, researchers are transplanting donor islets within a tissue-engineered scaffold on the omentum to learn whether the cells can successfully engraft and achieve insulin independence.

We will continue to keep you abreast of the status of these clinical trials as they develop. For continuing updates, please sign up to “Be a DRInsider” at Diabetes.Research.org/Register or email us at info@drif.org.

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