The Department of Health and Human Services (HHS) is asking the public whether insulin-producing islet cells from deceased donors should be regulated as organs for transplant rather than as biological products. HHS, through the FDA, released a request for information on September 23, and comments are due November 8, 2026. HHS stressed that it has not made a final decision and that the request does not change any current requirements.
For some people with type 1 diabetes who have repeated, dangerous episodes of low blood sugar, islet transplants can restore some natural insulin production, and some recipients no longer need insulin. Advocates say current rules limit access, while regulators must weigh the procedure's serious risks.
How Islet Transplants Work Today
Pancreatic islets are clusters of cells that include beta cells, which make insulin. In a transplant, islets taken from a deceased donor's pancreas are infused into a patient, usually through the portal vein, which carries blood to the liver. Functioning cells may then reduce or, in some cases, eliminate the need for insulin.
The FDA currently regulates these cells as biological products. In 2023, the agency approved Lantidra, the first cellular therapy made from deceased donor pancreatic cells to treat type 1 diabetes. It is approved only for adults with type 1 diabetes who cannot reach target blood sugar levels because of repeated severe hypoglycemia despite intensive diabetes management and education.
In the two studies supporting approval, 30 participants with type 1 diabetes and hypoglycemia unawareness received at least one infusion. Twenty-one went a year or more without needing insulin, including 10 who did not need insulin for more than five years. Five never had a single day without insulin.
Hypoglycemia unawareness means a person cannot sense that their blood sugar is dropping and may not have time to treat it, which makes insulin dosing difficult. Severe low blood sugar can lead to seizures, loss of consciousness, and injuries.
The benefits come with real risks. Most participants had at least one serious adverse reaction tied to the infusion procedure or to the immune-suppressing drugs needed to keep donor cells alive. Some serious reactions required stopping those drugs, which led to the loss of islet cell function and insulin independence.
What HHS Wants to Know
The request focuses on unmodified donor islet cells. If they were classified as organs, oversight of procurement, allocation, and transplantation could shift from the FDA to the Health Resources and Services Administration (HRSA) and the Organ Procurement and Transplantation Network, which maintains the national transplant waiting list.
According to the HHS announcement, the agency wants input on three questions: whether current FDA requirements create barriers that limit appropriate access, whether an organ-transplant framework could make these transplants more efficient and available, and what safeguards would be needed to protect patients under any alternative system.
"Deceased donor islet cells can give some people with type 1 diabetes the ability to produce insulin again," Health Secretary Robert F. Kennedy Jr. said. HHS added that the request does not change the regulatory status of any FDA-approved product or other donor islet cell product.
Advocates, Risks, and Next Steps
The request follows pressure from patient groups and lawmakers. Breakthrough T1D has urged HHS to reclassify the cells as organs, arguing that the change would increase islet availability, maintain rigorous safety standards, and address insurance coverage. Utah Sen. Mike Lee has introduced legislation to designate islet cells as organs and has pressed Kennedy to act, the Deseret News reported. An HHS spokesperson told the newspaper in August that the department was actively reviewing the matter.
Any change would help a limited number of people. Donor pancreases are scarce, and transplant recipients must take immune-suppressing drugs, which raise the risk of infections and other complications. The approved treatment is currently limited to adults with severe, hard-to-control low blood sugar episodes.
Families should keep expectations measured. The request does not speed up anyone's access to a transplant or create new insurance coverage. People with type 1 diabetes who have frequent severe lows or hypoglycemia unawareness should talk with an endocrinologist about current options, including continuous glucose monitors, automated insulin delivery systems, and referral to a transplant center. Severe low blood sugar with confusion, seizures, or loss of consciousness requires emergency care. The National Institute of Diabetes and Digestive and Kidney Diseases offers a plain-language overview of pancreatic islet transplantation.
Patients, caregivers, clinicians, and transplant centers can submit comments through Regulations.gov under Docket No. FDA-2026-N-10738. Any future rule change would likely require a separate proposal with its own comment period.
Key Questions Answered
What is HHS proposing? HHS is not proposing a rule. It is asking for public input on whether donor islet cells should be regulated as organs instead of biological products.
Who qualifies for the approved islet cell therapy now? Lantidra is approved for adults with type 1 diabetes who have repeated severe hypoglycemia despite intensive diabetes management and education.
How well do islet transplants work? In the studies behind Lantidra's approval, 21 of 30 participants went a year or more without insulin. Five never became insulin-free.
What are the risks? Most participants had at least one serious reaction linked to the procedure or to immune-suppressing drugs. Stopping those drugs can end the transplanted cells' function.
Which agency would oversee islets as organs? HRSA and the Organ Procurement and Transplantation Network would oversee procurement, allocation, and transplantation.
Does this change any current products? No. HHS said the request does not change the regulatory status of FDA-approved products or other donor islet cell products.
How can people comment? Submit comments through Regulations.gov under Docket No. FDA-2026-N-10738 by November 8, 2026.
Published by Medicaldaily.com
