What is lantidra?: The First FDA-Approved Cell Therapy for Type 1 Diabetes

October 6, 2025 •

3 min read

In June 2023, the U.S. FDA approved Lantidra, a major milestone as the first allogeneic pancreatic islet cellular therapy for type 1 diabetes. What is lantidra?, and how does this innovative treatment offer hope for adults experiencing debilitating episodes of severe hypoglycemia despite intensive insulin management?.

Quick Summary

An FDA-approved cellular therapy for adults with type 1 diabetes, Lantidra treats repeated severe hypoglycemia by transplanting insulin-producing pancreatic islets.

Key Points

FDA Approval: Lantidra is the first allogeneic pancreatic islet cellular therapy approved by the FDA for treating type 1 diabetes in adults.
Target Population: It is specifically indicated for adults with T1D who experience repeated, severe episodes of hypoglycemia despite intensive management.
Mechanism: The therapy works by infusing insulin-producing islet beta cells from a deceased donor into the patient's liver.
Requires Immunosuppression: Patients must take long-term immunosuppressive drugs to prevent the body from rejecting the donor cells, which carries risks of infection and cancer.
Potential for Insulin Independence: Clinical trials showed that some recipients achieved insulin independence for one year or more, but results vary, and not all patients benefit.
Not a Cure: Lantidra is not considered a cure for diabetes, and some patients may lose insulin independence over time.
Limited Availability: Due to the nature of the therapy, it is currently only available at a few specialized medical centers.

What is Lantidra? The Basics

Lantidra (donislecel-jujn) is the brand name for an allogeneic pancreatic islet cellular therapy. This groundbreaking treatment is designed for adults with type 1 diabetes (T1D) who experience repeated episodes of severe hypoglycemia despite intensive diabetes management. Unlike traditional medications that manage blood sugar from the outside, Lantidra introduces new insulin-producing cells into the body. These cells are harvested from the pancreas of a single, deceased donor.

The goal of the therapy is to restore the body's natural ability to produce insulin and regulate blood glucose levels. This offers a potential pathway to reduce or eliminate the need for exogenous insulin, bringing relief to a very specific and high-need patient population.

How Lantidra Works: Mechanism and Procedure

The primary mechanism of action for Lantidra involves the insulin secretion from the infused allogeneic islet beta cells. In T1D, the body's immune system mistakenly attacks and destroys the insulin-producing beta cells in the pancreas. Lantidra essentially replaces these lost cells. The infused islet cells travel to the liver, where they become lodged in small blood vessels and begin to release insulin in response to blood glucose levels, mimicking a healthy pancreas.

The Infusion Procedure

The procedure for administering Lantidra involves infusing a suspension of pancreatic islets into the hepatic portal vein. This is typically an outpatient procedure performed by specialized medical professionals. Patients are prepared with immunosuppressive medications before the infusion, and their blood glucose and portal vein pressure are monitored during the approximately 30-minute procedure. Post-procedure care includes monitoring for at least 24 hours in the hospital and continued immunosuppression and infection prophylaxis to support the transplanted cells.

Eligibility Criteria

To be considered for Lantidra, adult patients must meet strict qualifications. These include being 18 or older, having T1D for over five years, being insulin-dependent with a BMI below 27, experiencing frequent severe hypoglycemia or unawareness despite intensive management, and having no severe heart, lung, or liver problems. Patients also cannot have contraindications to long-term immunosuppression.

Benefits and Risks of Lantidra

Lantidra Benefits

Lantidra can offer significant benefits for eligible patients, including improved glycemic control and a reduction in dangerous hypoglycemic events. In clinical trials, many participants achieved insulin independence for at least one year, with some maintaining it for five years or more, potentially leading to a better quality of life.

Lantidra Risks and Side Effects

The risks are primarily related to the infusion procedure and the required lifelong immunosuppression. Procedural risks include bleeding, liver complications, and blood clots in the portal vein. Immunosuppression increases the risk of serious infections, certain cancers (like lymphoma and skin cancer), and severe anemia. Common side effects can include nausea, fatigue, diarrhea, abdominal pain, and headache.

Lantidra vs. Traditional Insulin Management


Feature	Lantidra (Cellular Therapy)	Standard Insulin Management (Injections/Pumps)
Treatment Mechanism	Replaces insulin-producing cells (islets) internally.	Administers insulin externally, requiring manual or automated dosing.
Effect on Insulin Need	Can potentially lead to a reduction or complete elimination of exogenous insulin.	Requires continuous exogenous insulin, with no potential for independence.
Target Population	Adults with severe, unstable T1D and severe hypoglycemia/unawareness.	All individuals with T1D needing insulin supplementation.
Associated Risks	Procedural risks (bleeding, liver issues) and long-term immunosuppression side effects (infection, cancer).	Risk of hypo/hyperglycemia, requiring careful monitoring.
Procedural Commitment	Involves a single- or multiple-infusion procedure and lifelong immunosuppression.	Requires ongoing, daily insulin administration and blood sugar monitoring.
Efficacy	Demonstrated long-term insulin independence in a portion of clinical trial participants.	Highly effective with intensive management, but challenging for some, especially those with hypoglycemia unawareness.
Availability	Very limited, offered only at select specialized centers.	Widely available through various formats (injections, pumps).

Conclusion: The Future of Lantidra

Lantidra is a significant advancement for a specific group of adults with type 1 diabetes, offering a biological treatment to restore insulin production. While not a cure and requiring lifelong immunosuppression with associated risks, it provides a potential improvement in quality of life for those with severe hypoglycemia. Current limitations include donor availability and the necessity of immunosuppression, making it suitable only for a select patient population. Ongoing research aims to develop more broadly applicable therapies for type 1 diabetes.

For more information on the FDA approval of Lantidra, visit the official FDA news release: FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes.

Frequently Asked Questions

Eligible adults must have T1D for over five years, be insulin-dependent, have a BMI below 27, and experience repeated severe hypoglycemia or hypoglycemia unawareness despite intensive management. Patients with significant heart, lung, or liver disease are typically not candidates.

No, Lantidra is not a cure for type 1 diabetes. It is a cellular therapy that can restore insulin production, but its long-term effects and the need for continued immunosuppression mean it does not fully resolve the underlying condition.

The most significant risks are related to the required lifelong immunosuppression, which increases the chance of serious infections and malignancies. The infusion procedure itself also carries risks like bleeding and liver complications.

In clinical trials, some participants achieved insulin independence for a year or more, with some lasting beyond five years. However, this is not guaranteed, and some individuals may need to resume insulin therapy.

The immunosuppressive medication is essential to prevent the patient's immune system from rejecting and destroying the transplanted islet cells, which are foreign tissue.

Lantidra is administered as an infusion into the hepatic portal vein, which delivers the islet cells to the liver. This outpatient procedure is performed by interventional radiologists or transplant surgeons.

The supply of cadaver-sourced pancreatic islet cells is inherently limited. This restriction is a major factor in the treatment's current limited availability and its applicability only to a small, specific group of patients.