University Hospitals Approved as a US Site - and the Only Site in Ohio - to Administer Breakthrough Treatment Lantidra for Type 1 Diabetes

CLEVELAND – Patients with Type 1 Diabetes (T1D) and persistent hypoglycemia can now receive a novel and life-changing treatment at University Hospitals. The breakthrough islet cellular therapy called Lantidra (donislecel) was approved by the Food and Drug Administration (FDA) in June 2023, but is only now becoming more widely available.

The CDC estimates that more than 2 million Americans have T1D, a life-long autoimmune disease. The insulin-producing cells in the pancreas are mistakenly attacked, leading to hyperglycemia (high blood sugar levels) or diabetic ketoacidosis, a life-threatening condition, if not treated with insulin therapy. Insulin therapy can also result in hypoglycemia (low blood sugars), requiring immediate treatment. T1D has no cure, and the disease requires monitoring blood sugar levels and insulin therapy to live and be healthy.

Lantidra is a treatment containing islet cells from a deceased donor pancreas. Islet cells are clusters of cells in the pancreas which produce hormones that help regulate blood sugar levels. Lantidra is administered as an infusion into the hepatic (liver) portal vein.

Eligible patients will undergo extensive screening with the UH Diabetes & Metabolic Care Center and the UH Transplant Institute to ensure they are suitable candidates for this therapy.

“It is incredibly exciting that Northeast Ohio patients living with T1D will be among the first in the country to have access to islet cell therapy and we are proud that UH has done the work to provide it,” said Zoe Stewart Lewis, MD, PhD, MPH, UH’s Chief of Transplant and Hepatobiliary Surgery, and James A. Schulak, MD, Endowed Director of the UH Transplant Institute.

The work to provide Lantidra to patients included becoming an approved UNOS (United Network for Organ Sharing) site. To do so, leaders and other caregivers at the UH Transplant Institute took on an application process which involved meeting specific requirements and providing required documentation. Becoming an approved UNOS site shows that a hospital is prepared and dedicated to quality care in this area.

“Lantidra is the most effective and longest lasting treatment that’s been FDA approved for T1D,” said Betul Hatipoglu, MD, Chief of Endocrinology, Medical Director of the Diabetes & Metabolic Care Center at UH, and the Mary B. Lee Chair in Adult Endocrinology at UH Cleveland Medical Center. “It’s an incredible breakthrough because in some patients with T1D, these infused cells can produce enough insulin so the patient no longer needs to take it by injections or pump, something they’ve been doing multiple times a day for years.”

Dr. Hatipoglu played a pivotal role as one of the original researchers who helped bring islet cell therapy to fruition during her tenure as Medical Director of the Pancreas and Islet Cell Transplant Program at University of Illinois Health (UIHealth) at Chicago. UIHealth at Chicago led the clinical trial and was the first site in the U.S. approved to administer Lantidra. A recognized expert in islet cell therapy, she continued her involvement with the project after joining University Hospitals. Dr. Hatipoglu has been invited to share her expertise on endocrinology and islet cell therapy at prestigious international forums including the FDA and at the World Health Organization.

Lantidra is approved for adults with T1D who experience repeated episodes of severe hypoglycemia despite intensive diabetes management and education. The treatment requires patients to receive accompanying immunosuppression. It is a one-time infusion, but patients may receive a second infusion if they do not achieve independence from insulin within one year of infusion, or within one year after losing independence from insulin following a previous infusion. A third infusion may be given following the same criteria used to indicate a second infusion.

Lantidra has shown remarkable results. In its clinical trial, at one-year post-infusion, 70 percent of patients achieved full insulin independence. At five years, 34 percent of patients remained insulin independent.

“The success and potential impact of this therapy are truly remarkable,” said Dr. Hatipoglu. “At University Hospitals, our mission is to bring the most advanced and effective treatments to our patients and the community we serve. Being able to offer what may be the best-yet and longest-lasting therapy for type 1 diabetes in history is both a profound milestone and source of hope. We are excited about the positive outcomes this could bring to the health and lives of our patients.”