The first cell therapy with allogeneic pancreatic cells for the treatment of type 1 diabetes has been approved by the US Food and Drug Administration. the new therapy, Lantidra (donislecel)can be administered to adults with type 1 diabetes who do not reach their glycosylated hemoglobin targets due to repeated episodes of severe hypoglycemia, in the context of intensive disease management.
The main mechanism of action of the new cell therapy is represented by the secretion of insulin by the infused pancreatic beta cells. In some patients, the transferred cells produce enough insulin so that exogenous administration via injections or pumps is no longer necessary to ensure glycemic control.
The safety and effectiveness of Lantidra was evaluated in two clinical studies that included 30 patients with type 1 diabetes and difficulty reporting hypoglycemic episodes. They received between one and a maximum of three administrations of cell therapy. Of the study participants, 21 did not need to use exogenous insulin for at least one year, 11 patients between one and five years, and 10 did not need to take insulin for more than five years.
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Type 1 diabetes is a chronic autoimmune disease that requires lifelong therapy, insulin administration being necessary daily, several times a day, or continuously with the help of a pump, for the patient to survive. Calculating insulin requirements can be challenging, and when the appropriate amount is exceeded, episodes of hypoglycemia occur. Some patients may not be aware of the presence of hypoglycemic episodes, so they are not managed properly.
Lantidra is an appropriate therapeutic option for patients experiencing episodes of hypoglycaemia despite intensive disease management efforts. Lantidra is administered only once, in the portal vein. Depending on the response to the first dose, another administration can be made.
Associated side effects depended on the number of doses administered. The most frequent were represented by nausea, fatigue, anemia, diarrhea and abdominal pain. Most of the participants had min. a severe adverse reaction determined by administration into the portal vein and the use of immunosuppressive drugs, which prevent the destruction of allogeneic cells by the patient’s immune system. When it was necessary, stopping the administration of immunosuppressive therapy determined the loss of the therapeutic effect and the need to resume the use of exogenous insulin.
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2023-07-15 08:07:50
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