The approval was granted based on the study evaluating the safety & effectiveness of Lantidra in patients (n=30) with type 1 diabetes who are unable to approach target glycated hemoglobin due to current repeated episodes of severe hypoglycemia
The results from the study depicted that out of the evaluable patients, 21 did not require insulin for ≥1yr.,11 for 1-5yrs. & 10 for ≥5yrs. As per the safety data, adverse reactions depicted in patients were associated with the number of infusions & follow-up time
Lantidra is an allogeneic pancreatic islet cellular therapy developed from deceased donor pancreatic cells that treats type 1 diabetes through infused allogeneic islet beta cells
Ref: PR News | Image: CellTrans
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