FDA Approves First Cell Therapy for Type 1 Diabetes

The treatment was developed to address patients struggling to maintain target blood glucose levels.

The U.S. Food and Drug Administration recently granted approval to CellTrans, Inc. for Lantidra. This “first allogeneic pancreatic islet cellular therapy” is acquired from deceased donor pancreatic cells, for the treatment of type 1 diabetes.

“Severe hypoglycemia is a dangerous condition that can lead to injuries resulting from loss of consciousness or seizures,” said the FDA’s Center for Biologics Evaluation and Research Director Peter Marks. “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 hypoglycemia an additional treatment option to help achieve target blood glucose levels.”

The therapy is administered through a single infusion into the “hepatic portal vein.” Lantidra is intended for adults with type 1 diabetes who struggle to achieve target blood glucose levels due to repeated severe hypoglycemic episodes regardless of diabetes management and education.

As the Lord Leads, Pray with Us…

  • For Commissioner Califf as he heads the Food and Drug Administration.
  • For Director Marks as he oversees the FDA’s Center for Biologics Evaluation and Research.
  • For Secretary Becerra as he manages the Department of Health and Human Services.

Sources: Food and Drug Administration


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