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FDA approves new cell therapy for type 1 diabetes

Diabetes Screening
Posted at 2:24 PM, Jun 29, 2023
and last updated 2023-06-29 17:52:34-04

SOUTHFIELD, Mich. (WXYZ) — This is great news for the nearly 2 million people in the U.S. who have Type 1 diabetes. That’s a chronic autoimmune condition where the pancreas produces little or no insulin. Patients must get lifelong care, which includes daily injections or infusions of insulin.

The FDA has given the green light to a cellular therapy called Lantidra to help adults with Type 1 diabetes maintain their target blood glucose levels.

Often, patients suffer from repeated episodes of severe hypoglycemia, or low blood sugar, because they have difficulty managing the right dosage of insulin. And, sometimes patients develop what’s known as “hypoglycemia unawareness.” That means they are unable to detect when their blood glucose is dropping, and without treatment they risk losing consciousness or having seizures.

So, here’s how Lantidra will help. First of all, this therapy is made from deceased donor pancreatic cells. It aims to replace the insulin-producing beta cells in the pancreas.

After the initial infusion, the cells secrete insulin into the body. And, in some cases, these cells can produce enough insulin that there is no longer a need for the patient to inject or pump insulin in order to control their blood sugar levels.

Well, initially, Lantidra is given to the patient as a single infusion into the portal vein, which is the blood vessel that delivers blood to the liver. An additional infusion can be performed depending on the patient’s response to the first dose.

During the two clinical studies, 30 participants with Type 1 diabetes and hypoglycemic unawareness received between one and three infusions of Lantidra. Afterwards, 11 of them did not need insulin for one to five years. And, 10 of the participants did not have to take insulin for more than five years. Only 5 of the patients were not able to get rid of their insulin dependence for any length of time.

The side effects varied depending upon the number of infusions the patients received and the length of time they were followed in the study. The most common were nausea, fatigue, anemia and abdominal pain.

However, a majority of the participants did experience at least one serious adverse reaction to the procedure for infusing Lantidra into the body and the use of immunosuppressive medications needed to keep the donor cell viable.

So, while this is a major breakthrough for the treatment of Type 1 diabetes, it is important for patients to first discuss the benefits and risks of the cell therapy with their doctors.

This Week on the Dr. Nandi show:

Whether or not you notice, racial discrimination affects our lives every day. Thousands of hate crimes happen in the U.S. each year. We have all heard horrific incidents of racial intolerance. And high numbers remain despite a decreasing number of active hate groups in the United States. So how do we as a society address the hate? Dr. Nandi joins a panel of racial activists to discuss how we as a society can move from intolerance to inclusion. Also, a licensed psychologist discusses where hate comes from and how young people learn about hate. And a group of experts offer solutions to close the racial gap not only in this country but worldwide. Tune in this Saturday, July 1stat 5:00 p.m.