Donislecel (Lantidra) a pancreatic islet cell therapy developed from cadaver donors, for the treatment of people with type 1 diabetes who are unable to achieve target glucose levels owing to severe hypoglycemic episodes.
The product is given as a single infusion via the hepatic portal vein into the liver.
Treatment involves the infusion of insulin producing pancreatic islet beta cells from deceased donors into patients to hepatic portal veins, and immunosuppressive medication to maintain iset cell viability.
Routes of administration Islet cell transplantation via intravenous infusion.
A second infusion is given if necessary. Immunosuppression is required to maintain cell viability, as these all represent foreign tissues to the recipient.
Donislecel differs from stem cell therapy.
It is a cellular therapy medication used for the treatment of type 1 diabetes.
It is an allogeneic pancreatic islet cellular therapy made from deceased donor pancreatic cells.
The primary mechanism of action of donislecel is believed to be the secretion of insulin by the infused allogeneic islet beta cells.
In some people with type 1 diabetes, these infused cells can produce enough insulin, so the recipient no longer needs to take insulin to control their blood sugar levels.
Insulin independence was achieved at 1 year by 21 participants; 11 were still insulin independent at 5 years, and 10 remained so more than 5 years.
Five participants were unable to discontinue insulin treatment at all.
Adverse events included nausea, fatigue, anemia, diarrhea, and abdominal pain.
The safety and effectiveness of donislecel was evaluated in two non-randomized, single-arm studies in which a total of 30 participants with type 1 diabetes and hypoglycemic unawareness received at least one infusion and a maximum of three infusions.
Overall, 21 participants did not need to take insulin for a year or more, with eleven participants not needing insulin for one to five years and ten participants not needing insulin for more than five years.
Five participants did not achieve any days of insulin independence.
Most of the participants experienced at least one serious adverse reaction related to the method of infusion and/or the use of immunosuppression.
Some of these reactions required discontinuation of the immunosuppressive medications, resulting in the loss of islet cell function and return to insulin dependence.