The FDA announced that it approved the Lantidra allogeneic pancreatic islet cellular therapy developed by CellTrans to treat diabetes.
It marks the first approval of a donor pancreatic cellular therapy — made from deceased donor pancreatic cells — to treat type 1 diabetes. The approval covers adults with type 1 diabetes who prove unable to approach targeted glycated hemoglobin. This occurs because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education.
Lantidra’s primary mechanism of action is believed to be the secretion of insulin by the infused allogeneic islet beta cells. In some type 1 diabetes patients, these cells can produce enough insulin to eliminate the need for the patient to inject insulin. CellTrans designed it for administration through a single infusion into the hepatic portal vein. An additional infusion may take place depending the patient’s response to the initial dose.
“Severe hypoglycemia is a dangerous condition that can lead to injuries resulting from loss of consciousness or seizures,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “Today’s approval, the first-ever cell therapy to treat patients with type 1 diabetes, provides individuals living with type 1 diabetes and recurrent severe hypoglycemia an additional treatment option to help achieve target blood glucose levels.”
How CellTrans got its cell therapy approved
CellTrans tested the safety and effectiveness of Lantidra in two non-randomized, single-arm studies. A total of 30 participants with type 1 diabetes and hypoglycemic unawareness received at least one infusion. Some received a maximum of three infusions.
Overall, 21 participants did not have to take insulin for a year or more, with 11 not requiring insulin for between 1-5 years. Ten demonstrated no need to take insulin for more than five years. Five participants failed to achieve any days of insulin independence.
Adverse reactions varied with each participant depending on the number of infusions and the length of time followed. Common adverse reactions included nausea, fatigue, anemia, diarrhea and abdominal pain. A majority of participants experienced at least one serious adverse reaction related to the procedure. This relates to infusing Lantidra into the hepatic portal vein and the use of immunosuppressive medications needed to maintain the islet cell viability.
Some serious adverse reactions required discontinuation of immunosuppressive medications. This resulted in the loss of islet cell function and insulin independence. Each patient should consider these adverse events while assessing the benefits and risks of the CellTrans Lantrida therapy.