CellTrans Inc FDA Approval for Lantidra for Type 1 Diabetes
The U.S. Food and Drug Administration (FDA) approved CellTrans Inc treatment Lantidra, the first allogeneic pancreatic islet cellular therapy made from deceased donor pancreatic cells for the treatment of adults having type 1 diabetes. The approval is for people who are unable to approach target glycated hemoglobin (average blood glucose levels) because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education.
Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research said, “Severe hypoglycemia is a dangerous condition that can lead to injuries resulting from loss of consciousness or seizures. Today’s approval, the first-ever cell therapy to treat type 1 diabetes provides the individuals living with type 1 diabetes and recurrent severe hypoglycemia an additional treatment option to help achieve target blood glucose levels.”
Type 1 diabetes is a chronic autoimmune disease that requires lifelong care including requiring insulin, either through multiple daily injections or continuous infusion using a pump, every day to live. People with type 1 diabetes also perform blood glucose checks several times a day to guide the management of their diabetes.
Some people with type 1 diabetes have trouble managing the amount of insulin needed every day to prevent hyperglycemia without causing hypoglycemia. They may also develop hypoglycemia unawareness, where they are unable to detect their blood glucose is dropping and may not have a chance to treat themselves to prevent their blood glucose from further dropping. This makes it difficult to dose insulin.
Lantidra provides a potential treatment option for these patients.
The primary mechanism of action of Lantidra: Is believed to be the secretion of insulin by the infused allogeneic islet beta cells. In some patients with type 1 diabetes, these infused cells can produce enough insulin, so the patient would no longer needs to take insulin either by injections or by a pump to control their blood sugar levels.
Lantidra is administered as a single infusion into the hepatic (liver) portal vein. An additional infusion of Lantidra may be performed depending on the patient’s response to the initial dose.
The safety and efficacy of Lantidra was evaluated in two non-randomized, single-arm studies in which a total of 30 participants with type 1 diabetes and hypoglycemic unawareness received at least one infusion and a maximum of three infusions.
Important to learn that overall, 21 participants did not need to take insulin for a year or more, with 11 participants not needing insulin for one to five years, and 10 participants not needing insulin for more than five years. Five participants did not achieve any days of insulin independence.
Adverse reactions associated with Lantidra varied with each participant depending on the number of infusions they received and the length of time they were followed and may not reflect the rates observed in practice. The most common adverse reactions included: Nausea, fatigue, anemia, diarrhea and abdominal pain.
A majority of participants experienced at least one serious adverse reaction related to the procedure for infusing Lantidra into the hepatic portal vein and the use of immunosuppressive medications needed to maintain the islet cell viability.
Some serious adverse reactions required discontinuation of immunosuppressive medications, which resulted in the loss of islet cell function and insulin independence. These adverse events should be considered when assessing the benefits and risks of Lantidra for each patient.
Lantidra is approved with patient-directed labeling to inform patients with type 1 diabetes about benefits and risks of Lantidra.
CellTrans Inc mission is to develop, manufacture, and commercialize FDA-approved cellular therapies and novel bioengineered technologies for therapeutic treatment of diabetes and other endocrine disorders. CellTrans vision is to improve the human condition through functional cures by bioengineered cell transplantation.
CellTrans is a faculty start-up company launched out of Dr. José Oberholzer’s scientific research group at the University of Illinois. Dr. Oberholzer has led the Islet Transplant Program at the University of Illinois since August of 2003 and his team has completed over 600 islet isolations as well as successful Phase I, II, and III clinical trials for islet transplantation.
The firm aims at bringing bring cell-based therapies including isolated islets, encapsulated islets, and human derived stem-cells to clinical application to combat the global epidemic of diabetes and other endocrine disorders.
The team includes expert scientists in the fields of diabetes and biomaterials and has highly trained technicians, experienced surgeons, and professional administrative staff.
At the core of CellTrans is the ethical and efficacious utilization of human organs and tissues for either therapeutic application or to provide exclusive research services.
The FDA approval of Lantidra is a large step towards in the treatment of Type 1 diabetes. Another advanced treatment on the horizon is being developed by Vertex (VRTX) with promising data.
We are lucky to live through these improvements in healthcare.