On This Day in Health: June 28, 2023
On June 28, 2023, the U.S. Food and Drug Administration approved Lantidra, the first cellular therapy made from deceased donor pancreatic islets for certain adults with type 1 diabetes. Developed by CellTrans, the treatment was intended for a narrowly defined group: adults unable to approach their blood sugar targets because of repeated severe hypoglycemia despite intensive diabetes management and education. The decision recognized a way to replace some of the insulin-producing capacity the disease had destroyed. It was a significant regulatory milestone for donor islet transplantation, with substantial risks that kept it from becoming a general treatment for everyone living with diabetes.
Pancreatic islets contain beta cells, which release insulin in response to changing glucose levels. In type 1 diabetes, the body's immune system destroys these cells, making insulin treatment essential. Yet some people continue to experience dangerous low blood sugar even with intensive management. Severe episodes can require help from another person, and impaired awareness may remove the warning symptoms that would otherwise prompt action. Lantidra used purified islets obtained from a deceased donor pancreas. Specialists infused the cell preparation into the recipient's hepatic portal vein, which carries blood to the liver, where surviving transplanted cells could provide a new source of insulin.
The approval drew on two studies involving a total of 30 adults, who received between one and three infusions. Twenty-one participants achieved insulin independence lasting at least a year, including 10 whose independence lasted more than five years. Five participants experienced no days of insulin independence. These were small, nonrandomized studies without a separate comparison group, so their results needed to be understood within those limits. The evidence demonstrated that transplanted donor cells could support meaningful periods without injected insulin for some recipients. It did not show that every treated person would respond or that a response would continue permanently, and some participants required additional infusions.
The tradeoffs were considerable. Recipients needed immunosuppressive medicines to protect the donor islets, creating risks including serious infections and other complications. The infusion procedure itself also carried dangers, and a majority of study participants experienced at least one serious adverse reaction linked to the procedure or immunosuppression. Some had to stop immunosuppressive treatment, losing the transplanted cells' function and their insulin independence. The therapy was based on donor tissue, rather than laboratory-grown stem cells, and did not remove the underlying complexity of type 1 diabetes. June 28 therefore marked an important, carefully bounded advance: an additional option for selected adults facing repeated dangerous episodes, with benefits that had to be weighed against the burdens of transplantation.
The treatment's intended population was defined by recurrent severe hypoglycemia despite intensive care. Its approval did not replace insulin therapy for the broader diabetes population.
Lantidra contained islets from deceased donor pancreases. Describing it as a stem-cell-derived treatment would confuse two different approaches to replacing insulin-producing cells.
The studies involved only 30 participants and no separate randomized control group. Their results supported approval for a limited population rather than a promise of universal success.
Insulin independence was an important outcome, but maintaining donor-cell function required immunosuppression. The risks of those medicines were central to evaluating the benefit.
The approval connected years of transplantation research with a defined regulated cellular product. Specialized manufacturing and clinical handling remained part of the treatment.
Its legacy is a measured example of cell replacement reaching clinical regulation. Long periods of benefit for some recipients coexisted with complications, nonresponse, and loss of function.
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