Curing type 1 diabetes (T1D) is Breakthrough T1D’s number one priority. As the leading global T1D research and advocacy organization, we are currently funding over $450 million in cures research in 23 countries. Everything we do is focused on making cures happen for the T1D community, sooner.
We are very excited to see the trials we fund having such positive results, including University of Chicago’s trial testing Eledon’s tegoprubart. This trial uses deceased donor islets, which come from the pancreases of deceased organ donors. We know we need more deceased donor islets available so more eligible adults can have access to islet cell transplants.
To achieve this pressing goal, we have urged the Department of Health and Human Services (HHS) to reclassify deceased donor islet cells from biologics (drugs) to organs in the United States.
We are very grateful to the sponsors and supporters of the ISLET Act for their engagement on deceased donor islet cell transplantation and for helping to generate a discussion about increasing deceased donor islet cell availability.
Passing legislation is extremely difficult at best, and the ISLET Act does not require development of safety standards for reclassified deceased donor islet cell transplants that would ensure the islet cells are healthy and safe for transplant. Nor does it address insurance coverage, which could limit access to these costly treatments.
Reclassifying deceased donor islet cells as organs can be accomplished using existing HHS authority. New legislation is not needed. And so, with the full support of leading islet transplant surgeons, we’re putting 100% of our effort toward working with HHS, which has much better odds of success.
If implemented, our proposal to HHS would increase deceased donor islet availability, ensure rigorous safety standards, and address insurance coverage.
Continued research funded by Breakthrough T1D and others has shown deceased donor islet cell transplants to be safe and effective for adults with T1D who experience severe hypoglycemia and hypoglycemia unawareness. These procedures can significantly reduce—or even eliminate—the need to administer insulin.
With the science clear and patients waiting, Breakthrough T1D is calling on HHS to use its existing authority to safely expand availability of deceased donor islet cell transplants in the United States.
Read Breakthrough T1D’s letter and proposal to HHS.