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In the United States, the Food and Drug Administration (FDA) has just approved an innovative treatment for type 1 diabetes: Lantidra. This drug is based on cell therapy for diabetes, which involves transplanting insulin-producing cells from human pancreas from brain-dead donors in the context of organ donation.
Type 1 diabetes is characterized by insufficient insulin secretion by the pancreas. Without insulin, cells can no longer use blood sugar (blood sugar) properly, increasing the risk of hyperglycaemia (high blood sugar), often followed by hypoglycaemia (too low blood sugar). The FDA-approved treatment, called Lantidra, is for adults with type 1 diabetes who fail to regulate their blood sugar levels due to repeated episodes of hypoglycemia (low blood sugar), and this, despite insulin injections several times a day and lifestyle and dietary measures. “Severe hypoglycemia is very dangerous for health because it can cause loss of consciousness and even seizuressaid Peter Marks, director of the Center for Biological Evaluation and Research at the FDA.
Treatment administered as an infusion
Lantidra is the first treatment to use cell therapy in the management of type 1 diabetes. It consists of “reactivating” pancreatic cells to boost the natural production of insulin. These cells come from human pancreases taken from brain-dead donors in the context of organ donation.
In some patients with type 1 diabetes, these cells can produce enough insulin that patients no longer need to take insulin injections to control their blood sugar levels.
Lantira is given as a single infusion directly into the hepatic portal vein. An additional infusion may be given to some patients, depending on the response to the initial dose.
No more insulin injections
The efficacy and safety of Lantidra have been assessed in two studies in 30 people with type 1 diabetes who were prone to severe hypoglycaemia. Participants had received at least one infusion and a maximum of three infusions for some.
The Lantidra treatment enabled 21 of the participants to stop insulin injections for one to five years. Among them, 11 stopped insulin injections for one to five years, and 10 stopped insulin injections for more than five years. Of the 30 participants, only 5 could not stop daily insulin injections.
The most common side effects seen in participants were nausea, fatigue, anemia, diarrhea and abdominal pain. The majority of them reported at least one serious adverse effect linked to the setting up of the Lantidra infusion in the portal vein and the use of immunosuppressants necessary for the viability of the grafted cells.