First-Ever Cell Therapy for Type 1 Diabetes Approved by FDA
The FDA has approved Lantidra (donislecel), the first donor pancreatic islet cell therapy for adults with type 1 diabetes (T1D)
The U.S. Food and Drug Administration (FDA) has approved the use of Lantidra (donislecel), the first donor pancreatic islet cell therapy for adults living with type 1 diabetes (T1D).
Lantidra, developed by CellTrans, is a cell therapy that makes use of insulin-producing pancreatic islet beta cells from donors. It is approved only for adults with type 1 diabetes who struggle to reach suggested HbA1c levels due to frequent severe hypoglycemic episodes, despite education and intensive diabetes management efforts.
Islet cell transplants have been available in the United States for decades. However, this particular treatment is the first cell therapy to be approved by the FDA. It is intended for those with T1D who also experience level 3 hypoglycemia, or hypoglycemia so severe that the person cannot function normally and may require assistance from someone else.
For those with T1D, managing glucose levels is a balancing act: people with this disease are forced to walk a thin line between giving insulin doses to prevent hyperglycemia while also trying not to cause hypoglycemia. Some have more difficulty with this than others, and may develop hypoglycemic unawareness, where the individual is unable to identify a hypoglycemic event and may miss the chance to treat it before glucose levels drop even further. Repeated instances of hypoglycemic unawareness may eventually lead to level 3 hypoglycemia.
Lantidtra provides an additional treatment option for T1Ds in this population.
How does Lantidtra work?
Made from pancreatic cells obtained from deceased donors, an infusion of Lantidra travels to the liver and aids in the production and secretion of insulin in the host. For some on this cell therapy, the infused cells can produce enough insulin so that the individual no longer requires insulin via injections or pump to manage blood glucose levels.
In safety and efficacy studies for Lantidra, where 30 participants received from one to three infusions, most did not need to take insulin for a year or more, while nearly one-third of the participants did not need external insulin for more than five years. However, five participants remained dependent on external insulin throughout the trial.
Though this therapy may sound magical, Lantidra comes with multiple risks, safety precautions and ethical considerations.
Due to the nature of this cell therapy, those who decide to embark on this journey must also weigh the potential for dependence on long-term immunosuppressive medications, increased infections and cancer risk as a result of this immunosuppressant use, and a limited supply of pancreatic islet beta cells from donors. In early safety studies, post-operative complications after infusion included liver lacerations, bruising of the liver, and anemia. People who take Lantidra may experience side effects such as nausea, diarrhea, fatigue, anemia, and abdominal pain. Furthermore, those interested in this treatment must also consider that the quality of the human islet cells donated may not be verified before transplantation, and may compromise the safety of the host.
If you think you may be a candidate for Lantidra, you could have many important conversations ahead of you. Please speak with your physician or your IDS clinician as you contemplate whether this cell therapy is right for you.
Article by IDS Volunteer, Krystal Bosenbark, MPH, MS
Integrated Diabetes Services is the worldwide leader in one-on-one consulting for people who use insulin. Diabetes “coaching” services are available in-person and remotely via phone and the internet for children and adults.