New therapy from UI Health becomes the first FDA-approved treatment for brittle type 1 diabetes

A new therapy for brittle type 1 diabetes, the only treatment currently approved by the U.S. Food and Drug Administration, is available exclusively at UI Health in Chicago.

Pancreatic islet cell therapy is a treatment approved by the FDA only for adults with type 1 diabetes who struggle to control their blood sugar levels due to frequent episodes of severe low blood sugar and hypoglycemia unawareness, a condition that occurs when patients can't detect that their blood sugar is dropping. This new therapy, called Lantidra, is derived from a deceased donor pancreas. To regulate blood glucose, the drug is infused into the patient's liver where insulin is produced. Lantidra requires a donor match determined by the United Network for Organ Sharing. 

According to Dr. Enrico Benedetti, head of surgery at UI Health, most patients in the clinical trial no longer required insulin one year after their transplant.

"In previous clinical trials, 70% of patients who received Lantidra no longer required insulin one year post islet transplant and over 90% no longer experienced hypoglycemia," said Benedetti, who was instrumental in the development of Lantidra.

Before islet cell transplantation, the only treatment option for brittle type 1 diabetes was a pancreas transplant.

If the Lantidra therapy is successful, the islet cells lodge in the small blood vessels of the liver and begin producing insulin. Patients must take immunosuppressant drugs to prevent rejection of the islet cells. In some cases, patients require more than one infusion of donor islet cells to produce enough insulin. The success of the treatment varies from patient to patient.

Type 1 diabetes is a chronic autoimmune disease that requires lifelong care. Patients with type 1 diabetes need multiple daily insulin injections or an insulin pump because their own immune system destroys the insulin-producing cells of the pancreas. Even with insulin, they can develop life-threatening complications, including damage to the heart and blood vessels, eyes, nerves and kidneys. The cause of type 1 diabetes is unknown.

According to the National Institutes of Health, more than 1.4 million people in the United States have type 1 diabetes. Roughly 80,000 people have brittle type 1 diabetes, a more severe form of type 1 diabetes. The disease can lead to blindness, kidney failure, limb amputation, stroke and heart attack.

Lantidra, approved by the FDA in June 2023, was developed through research at University of Illinois Chicago. The clinical trials that supported Lantidra were conducted at UI Health, UIC's academic health enterprise. The clinical data was licensed to CellTrans Inc. to develop the therapy for FDA approval.

Lantidra joins Phexxi, Prezista, Shingrix and Tice BCG in UIC's portfolio of FDA-approved therapies.

"Our team has come full circle with this product, and we are elated to be at the finish line with this huge project that started in 2004," said Dr. Lorenzo Gallon, medical director of UI Health's abdominal organ transplant program and director of transplant research and the transplant research laboratory.

Dr. José Oberholzer, founder and president of CellTrans Inc. and the principal investigator of the islet transplant clinical trials completed at UIC, said Lantidra is "the culmination of more than 20 years of collaborative work.

The FDA approval is a significant milestone achieved as a result of physicians and co-investigators, a dedicated nursing and isolation team and a small academic startup company."

Dr. José Oberholzer, founder and president of CellTrans Inc.

Patients must meet qualifications to be considered for Lantidra. Eligible patients must be 18 years old or older, have type 1 diabetes for more than five years, be insulin-dependent and have a body mass index lower than 27. Eligible patients also need to have experienced either a serious episode of low blood sugar in the past three years or severe hypoglycemia unawareness, despite trying to manage their diabetes with insulin. It is recommended that eligible patients have no other serious health problems with their heart, lungs, liver or brain and have no active infections.