At a Glance

  • The Islet Act is legislation that would reclassify deceased donor islets as organs.
  • First introduced in 2023, it is generating a lot of buzz in the T1D community following positive Tegoprubart interim trial results.
  • Supporters believe it will allow wider access to treatment with FDA-approved deceased donor islet transplantation.
  • Critics argue there will only be a minimal increase in transplant recipients, that it does not solve the immunosuppression barrier, and express concerns over the lack of patient safeguards.
  • If the Islet Act opens access to meaningful care, it is worthwhile. However, it is not a Practical Cure as access would expand marginally, and the procedure still requires chronic immunosuppression. 
  • We must keep our attention and resources focused on finding a solution available to everyone battling T1D.

March 12, 2026

The Islet Act has been a topic of frequent discussion in the T1D community for the past several weeks, flooding online newsstands and sparking national interest. The Islet Act is legislation that aims to reclassify donated insulin-producing islet cells from ‘biologic drugs’ to ‘organs.’ This is a transition many believe will greatly increase the number of patients who can receive deceased donor islet transplants, sparking hope that this move will result in a cure.
 
The following provides a rundown of what the Islet Act is and isn’t, the argument surrounding its approval, and the implications for a Practical Cure.
 

The Islet Act

Background

The Islet ACT (Increase Support for Life-saving Endocrine Transplantation) is a bill currently under review by Congress that would reclassify deceased-donor (cadaveric) islets from biologic drugs to organs. It does not directly address stem cell-derived beta cells (sBCs). If it were to remain as a biological drug, the procedure could be protected by FDA exclusivity (to a company) and/or patent protection. Supporters believe that moving to organ designation could avoid a single-company bottleneck and would, therefore, expand patient access. Today, only twenty to thirty transplant procedures are conducted in the US per year, on average.
 
Despite gaining traction now, the bill was first introduced in June 2023 following the FDA’s approval of CellTrans’ Lantidra, a donor-sourced islet transplant therapy for individuals with T1D and severe hypoglycemia.
 
CellTrans’ technique is based on the Edmonton Protocol, considered the first successful donor islet transplantation method, resulting in limited insulin independence in T1D patients for upwards of ten years. The technique uses deceased donor cells and chronic immunosuppression. 

Why Now?

The bill was reintroduced to Congress by Senator Mike Lee (R-UT) on November 5, 2025. It has since gained significant press coverage from diabetes organizations, passionate grassroots advocacy, and heightened social media activity stemming from personal testimonies of participants in a human trial of Tegoprubart, a new, less toxic immunosuppressive drug.
 
Tegoprubart, developed by Eledon Pharmaceuticals, is a form of immune protection believed to be less harsh than the traditional immunosuppressant Tacrolimus, which carries a serious risk of adverse effects. Eledon reported interim results earlier this year that six of eight test patients are insulin-independent. The trial is expected to close in 2029.
 

The Discussion

The Islet Act has generated much discussion both in and outside of the T1D community.

Supporting Points

Wider Availability for High Risk T1D 
The primary argument for approval is that donor islets provide wider access for more people. Once approved, access to donor cell islet transplantation might expand, particularly to those with labile, hard-to-control T1D. For some, it is a potentially lifesaving treatment.
 
Align with Other Countries
A second argument compares the US to other countries, such as Japan, the United Kingdom, and Canada, that already classify donor islets as organs.
 
Commercialization of Organs as Unethical
Many argue that organ donation itself is an altruistic act, and the commercialization of donated tissues is unethical.

Counterpoints

Does Not Solve Cell Supply Limitations 
The primary counterargument is that cadaveric donor islets are very hard to acquire, and even if the Islet Act is approved, transplants will only be available to a select few. Only when a recently deceased donor is available are the cells available, and each transplant requires multiple donors.
 
Does Not Solve the Need for Full-body Immunosuppression
The safety concerns surrounding full-body immunosuppression remain. Even if the Islet Act is approved, a person would still be taking full-body immunosuppressive drugs for life, which is not feasible for the majority of the T1D community.
 
Does Not Include Patient Safeguards
The Islet Act does not specify how donor islets are regulated or how quality is maintained, nor does it provide other patient safeguards.

Breakthrough T1D Position: HHS Must Address

Breakthrough T1D recently advocated that the best route to change the classification of donor islets is through the Department of Health and Human Services (HHS) rather than through a House Bill. “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.” 
 

What Does This Mean for a T1D Cure?

Although there is a chance that good may come from this reclassification, it is not a Practical Cure, nor will it accelerate us toward one. A Practical Cure solution must include a sustainable supply of insulin-producing cells and a way to protect them from the immune system without chronic immunosuppression. This reclassification does neither.
 
That said, if the Islet Act meaningfully expands the number of people with hard-to-manage T1D who can receive a transplantation procedure, it is worthwhile. But it is not a long-term solution or the end goal. Donor islets are not a sustainable source of insulin-producing cells—this will not change. Broad immunosuppression is not a sustainable solution for cell protection.
 
Stem cell-derived beta cells are the most promising route to creating a sustainable cell supply, with the lead horse currently in phase III human trials. One sBC can be replicated indefinitely, with identical quality and efficacy, and must maintain its designation as a biologic drug.
 
Conversations surrounding the Islet Act must not ultimately shift community attention, resources, or expectations away from a Practical Cure that would definitively benefit everyone in the T1D community. Reclassification of donor islets may make the procedure available to more people with the most brittle T1D cases, but it is only applicable for the minority, not a solution for everyone.

It is important that JDCA’s focus is on finding a solution with the scope and scale to be available to everyone battling T1D. We strongly believe this goal must be the top priority for our research community, and resources should not shift away from a Practical Cure.