FDA blesses CellTrans' Lantidra, the first cell therapy for Type 1 diabetes

Much attention has been paid to Vertex’s efforts to develop a stem cell therapy for Type 1 diabetes. But flying under the radar with an allogenic (donor) gene therapy for the disorder has been Chicago startup CellTrans.

Thursday, the FDA signed off on CellTrans’ Lantidra (donislecel), the first cell therapy for Type 1 diabetes. The treatment, mined from deceased donor pancreatic cells, is for patients who are unable to achieve average blood glucose levels with daily insulin injections or with continuous infusion by way of a pump.

“Severe hypoglycemia is a dangerous condition that can lead to injuries resulting from loss of consciousness or seizures,” Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research, said in a release. “Today's approval … provides individuals living with type 1 diabetes and recurrent severe hypoglycemia an additional treatment option to help achieve target blood glucose levels.”

There are 1.9 million people in the U.S. with Type 1 diabetes. Among them are patients who have difficulty managing the amount of insulin they need to prevent hypoglycemic episodes. They may also develop hypoglycemia unawareness, the FDA said, where they are unable to detect when their blood sugar is dropping. Lantidra is a treatment option for these patients.

Lantidra is infused into the liver portal vein, with a second dose administered to some patients depending on their response to the first infusion. Secretion of insulin by the infused cells can produce enough to free some patients from daily injections or a pump.

Two studies, which totaled 30 participants, showed varying levels of success for Lantidra. While five patients did not achieve insulin independence, 11 did not need insulin for one to five years and 10 others did not need it for more than five years. Patients received between one and three doses.

Some adverse reactions to the therapy required patients to discontinue immunosuppressive medicines, which ended their insulin independence. Immunosuppressants are needed to prevent the body from destroying infused cells.

Lantidra is two decades in the making. It was the initial project of CellTrans, which was established in 2003 by University of Illinois Professor Jose Oberholzer, M.D.

In April of 2021, an FDA advisory committee voted 12-4, saying that the benefits of the therapy outweighed the risks.

Last week, Vertex reported that two patients who had received its stem cell treatment more than a year ago no longer needed injections. Stem cell treatments are believed to be more reliable and healthier than those from deceased donors.