The Islet Cell Act is a bill currently stalled in U.S. Congress, first introduced in 2023 by Senator Mike Lee of Utah. Right now, donor islet cells are regulated by the FDA as a drug, making them difficult and expensive to access for both patients and researchers. The act would reclassify islet cells as donated organs, shifting oversight to the Health Resources and Services Administration, making islet cell transplants more accessible for people with type 1 who are severely struggling.

At the center of why this bill is gaining so much attention right now is the Eledon trial. The trial pairs donor islet cells with a targeted immunosuppression drug called Tegoprubart, which is far less invasive than the traditional transplant drug Tacrolimus. Rather than suppressing the entire immune system, Tegoprubart blocks a specific immune response that would otherwise attack the transplanted cells. Participant Katie Beth, patient number nine, has achieved 100% time in range and no longer takes long-acting insulin, all while living a largely normal daily life.

We broke all of this down on the podcast with fellow T1D and diabetes journalist Ginger Vieira of the Diabetes Nerd Network. We also get into scalability challenges, how Eledon compares to lab-grown cell approaches, the pig islet cell trial requiring no immunosuppression, and why Breakthrough T1D is focusing their energy elsewhere. Listen above or watch below.

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