Our Statement on Deceased Donor Islet Cell Availability & The ISLET Act
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.
Deceased Donor Islet Cell Transplantation 101
Here’s what you need to know about deceased donor islet cell transplants—and our plan to expand availability to them safely and responsibly.
What Is Deceased Donor Islet Cell Transplantation?
Deceased donor islet cell transplantation is a procedure in which insulin-producing islet cells are isolated from the pancreases of deceased donors and transplanted into a person living with type 1 diabetes (T1D). These islets are infused into the liver, where they can begin producing insulin in response to blood glucose levels.
Deceased donor islet cell transplants are intended for, and only FDA-approved for, adults with T1D who experience:
- Severe hypoglycemia (dangerous low blood sugar)
- Hypoglycemia unawareness (the inability to sense when blood sugar is dropping)
These individuals often cannot safely manage their blood glucose levels with the standard therapies used to manage T1D, including continuous glucose monitors (CGMs) and automated insulin delivery (AID) systems.
Do They Work?
Yes. For adults with T1D who experience severe hypoglycemia and hypoglycemia unawareness, deceased donor islet cell transplantation has been shown to significantly reduce—or even eliminate—the need to take external insulin.
Do Deceased Donor Islet Cell Transplants Require Immunosuppression?
Yes. Recipients of deceased donor islet cell transplants must take immunosuppressives to prevent the body from rejecting the transplanted cells. Due to the side effects of immunosuppressives, these transplants are only approved for adults whose risk from severe hypoglycemia outweighs the risks associated with immunosuppression.
Breakthrough T1D is working on alternatives to traditional immunosuppression so more people can benefit. This includes our funding of the University of Chicago’s clinical trial with Eledon’s drug, tegoprubart.
Why Aren’t They Widely Available?
Deceased donor islet cells come from organ donors. A single transplant often requires multiple pancreases as isolating islet cells is a complicated process. In addition to those challenges, the availability in the U.S. is more limited than it is in other countries due to regulatory classification.
The U.S. currently regulates deceased donor islet cells as biological drugs requiring a Biologics License Application (BLA). This is different from how whole organ transplants are regulated in the U.S. and how deceased donor islet cells are regulated in many other countries, including Canada, the United Kingdom and countries in the European Union.
Our Strategy to Increase Availability
How Is Breakthrough T1D Advocating for Expanded Deceased Donor Islet Cell Transplant Availability?
Breakthrough T1D has strongly urged HHS to reclassify and expand availability of deceased donor islet cells.
Our proposal outlines a framework to ensure safety and accessibility for the T1D community. You can read the letter here.
We are putting 100% of our energy behind this approach, and we are doing it with the full support of leading transplant surgeons and organizations.
Why Is Breakthrough T1D Pursuing This Route (HHS) as Opposed to Legislation (ISLET Act)?
This is our best chance of success. Passing legislation is extremely difficult at best, and HHS has existing authority over the regulatory framework governing cell therapies and organ transplantation. They can make this change.
Additionally, the ISLET Act does not require the development of safety standards for reclassified deceased donor islet cell transplants, nor does it address insurance coverage, which could limit access to these costly treatments.
What Are the Details of Breakthrough T1D’s Recommendations in the Letter to HHS?
Our proposal outlines a clear strategy to ensure the safety and quality of deceased donor islet cells under this reclassification. They include:
- Designating Centers of Excellence staffed with experts in deceased donor islet cell transplants
- Strict quality control to ensure islets are functional—and they work
- A way to get cells from the deceased donors’ pancreases and into people with T1D
- A strategic roadmap for adding additional centers
Why Not Work with HHS and Support the ISLET Act?
Our Breakthrough T1D legislative agenda includes several critical priorities essential to advancing our mission. This includes the ongoing renewal of the Special Diabetes Program (SDP) to fund T1D research and efforts to improve insulin affordability. These issues require legislative action, which is why we continue to focus our legislative advocacy on them.
Not every priority is best achieved through Congress. Reclassifying deceased donor islet cells as organs, for example, can be accomplished under current law through the Department of Health and Human Services (HHS), without new legislation. This is one of the key reasons we believe the path through HHS is the best path for this issue.
Simply put, we are pursuing each of our priorities through the channel where it has the greatest likelihood of success. And given how difficult it is to pass legislation, putting 100% of our effort toward working with HHS has the best chance of success.
Why Doesn’t Breakthrough T1D Recommend an Amendment to the ISLET Act?
Given how difficult it is to pass legislation, we believe our effort to reclassify deceased donor islet cells as organs is much more likely to succeed focusing on HHS.
What effect would this have on stem cell-derived islets?
Breakthrough T1D believes that stem cell-derived islets are appropriately regulated by FDA as biologic products. There is no need to change the regulatory status for manufactured islets. If adopted, our proposal would not affect them.
Through Project ACT, Breakthrough T1D is working with all parties to clear the way for future, manufactured islet therapies and to ensure they are accessible.
Breakthrough T1D’s Role in Islet Cell Therapies
Has Breakthrough T1D Supported This Work?
Yes—Breakthrough T1D has been a leader in islet cell transplantation for decades. Breakthrough T1D is currently funding over $450 million in cures research in 23 countries, including the University of Chicago trial testing Eledon’s drug, tegoprubart. Breakthrough T1D’s support goes beyond funding these clinical trials. The T1D Fund: A Breakthrough T1D Venture, invested in Eledon in 2023.
What Is Breakthrough T1D’s Strategy to Increase Access?
In 2024, Breakthrough T1D launched a flagship initiative, known as Project ACT (Accelerate Cell Therapies), designed to advance breakthroughs in T1D cell therapies, an anticipated pathway toward cures for T1D. Learn more about our work within research, medical affairs, and advocacy via the timeline at the bottom of our Project ACT landing page.
Is Breakthrough T1D Alone in These Efforts?
No. Breakthrough T1D is working with other T1D and diabetes organizations in the U.S. and around the globe, and top islet transplant surgeons. They support our efforts and agree that this is the best way forward.
How Can I Get Involved in This Work?
If you are in the United States, sign up to be a grassroots advocate here to get real time policy updates, action alerts, and tips for contacting your lawmakers.
If you live with type 1 diabetes, you can also be part of advancing treatments like this by participating in clinical trials. Visit our dedicated T1D clinical trial match tool here.
