FDA Approves [CellTrans] Lantidra, the First Ever Cell Therapy for Type 1 Diabetes

[Hamartia Antidote]

FDA Approves Lantidra, the First Ever Cell Therapy for Type 1 Diabetes

Lantidra (donislecel) by Celltrans receives FDA approval as first-ever pancreatic islet beta cell therapy for treatment of type 1 diabetes.

diatribe.org

The FDA has approved Lantidra (donislecel), a revolutionary treatment for people living with type 1 diabetes. Lantidra works by restoring the body’s beta cells, potentially eliminating the need for external insulin.

Lantidra (donislecel), a cell therapy that helps to restore functional pancreatic islet cells in patients unable to produce insulin, has become the first cell therapy to ever be approved by the FDA for people with type 1 diabetes.

Donislecel, which has been developed by the startup CellTrans under the brand name Lantidra, offers a potential solution for people with T1D by introducing insulin-producing pancreatic islet beta cells from donors, reducing or eliminating the need for external insulin administration. The treatment has been approved for people with type 1 diabetes who struggle with severe hypoglycemia.

“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 hypoglycaemia an additional treatment option to help achieve target blood glucose levels,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said.

How does Lantidra work?​

Lantidra is made from pancreatic cells obtained from deceased donors. These cells, known as allogeneic islet beta cells, have the ability to produce and secrete insulin.

When Lantidra is infused into the body, specifically into the hepatic portal vein, it allows the islet beta cells to enter the bloodstream and reach the liver. Additionally, immunosuppressive medications are needed to maintain the transplanted islet cells’ viability.

Once inside the liver, the new infused islet beta cells begin to secrete insulin. If the infused cells produce enough insulin for the body, they can regulate blood glucose levels without the need for additional insulin injections or pumps.

Pancreatic islet cell transplantation has been successful in small numbers since the 1980s in a small subset of people with type 1 diabetes, but the procedure comes with caveats, including dependence on long-term immunosuppressive medications, limited access to insulin-producing pancreatic islet beta cells from donors, and increased incidence of infections and cancer as a result of immunosuppressant use.

Who is Lantidra for?​

At this time, Donislecel is specifically only approved for people with type 1 diabetes who experience level 3 hypoglycemia. “Lantidra is approved for the treatment of adults with type 1 diabetes who are unable to approach target glycated hemoglobin (average blood glucose levels) because of current repeated episodes of severe hypoglycemia (low blood sugar) despite intensive diabetes management and education,” the FDA said in a June 28 statement.

In a clinical study of 30 participants with T1D and hypoglycemia unawareness, 21 participants did not have to use external insulin for one year or longer. Among them, 11 individuals maintained independence for one to five years, while 10 participants remained insulin-free for more than five years. However, it is important to note that not all participants experienced the same level of success, and some did not achieve any days of insulin independence.

People with type 1 diabetes (T1D) rely on external insulin administration. Some experience hypoglycemia unawareness, or the inability to detect when blood glucose levels are dropping, which can result in severe hypoglycemia as well as difficulty achieving glucose target levels.

Safety and ethical concerns about Lantidra​

Early data has shown that a majority of participants in the Lantidra clinical study were able to achieve some level of insulin independence, but it’s unclear whether the benefits of donislecel outweigh the treatment’s safety risks. Nearly 87 percent of participants reported infection-related adverse events, and post-operation complications included liver lacerations, bruising of the liver (hepatic hematoma), and anemia. One patient died of multi-organ failure from sepsis, which Lantidra maker CellTrans stated was “probably related” to the use of either immunosuppression or study drugs.

In addition, some industry leaders have raised the question of whether it’s ethical to commercialize the use of deceased donor islet cells.

“A for-profit company … would obtain permission to market and sell human islets despite not being able to verify quality and sterility before transplantation,” a group of pancreatic islet transplant surgeons argued in the medical journal Frontiers in Endocrinology. “Transplant centers … will have no choice but to purchase human islets of unknown and unverifiable quality from a private company and transplant these into their patients … [This] compromises patient safety and trust in regulations and differs significantly from rules that govern organ transplantation.”

Side effects of Lantidra​

Common side effects of Lantidra include nausea, fatigue, anemia, diarrhea, and abdominal pain. Some participants experienced serious adverse reactions, primarily related to the infusion procedure and the use of immunosuppressive medications. Discontinuation of these medications, in some cases, resulted in the loss of islet cell function and a return to dependence on external insulin. Lantidra comes with “patient directed labeling” so that people with diabetes can understand the potential benefits and risks of treatment.