Profile
General Information
Lantidra is an allogeneic pancreatic islet cellular therapy
Lantidra is specifically indicated for the treatment of adults with Type 1 diabetes who are unable to approach target HbA1c because of current repeated episodes of severe hypoglycemia despite intensive diabetes management and education.
Dosing/Administration
Lantidra is supplied as a suspension for hepatic portal vein infusion.
Do not irradiate. Do not use leukodepleting filters. Do not use if product time exceeds 6-hours post product release or if temperature is not maintained between 15 and 25º C
The recommended minimum dose is 5,000 equivalent islet number (EIN) per kg patient body weight for initial infusion (transplant) and 4,500 EIN/kg for subsequent infusions (same recipient). Administer cells through the hepatic portal vein. The estimated tissue volume should not exceed 10 cc per transplant infusion.
A second infusion may be performed if the patient does not achieve independence from exogenous insulin within one year of infusion or within one year after losing independence from exogenous insulin after a previous infusion. A third infusion may be performed using the same criteria as for the second infusion. There are no data regarding the effectiveness or safety for patients receiving more than three infusions.
Mechanism of Action
Pancreatic islets regulate blood glucose levels through secretion of multiple hormones in response to increases and decreases in blood glucose. Endocrine cells within pancreatic islets release insulin, glucagon, somatostatin, pancreatic peptide, and ghrelin. Insulin stimulates glucose uptake by peripheral tissues; glucagon mobilizes glucose from the liver into circulation; somatostatin inhibits both α- and β-cell secretions; pancreatic peptide inhibits pancreatic exocrine secretion; and ghrelin inhibits insulin secretion. The primary mechanism of action of Lantidra is believed to be secretion of insulin by infused (transplanted) β- cells.
Side Effects
Adverse effects associated with the use Lantidra may include, but are not limited to, the following:
- nausea
- fatigue
- anemia
- diarrhea
- abdominal pain
Infusion procedure
- liver laceration/hematoma
- hemorrhage
- intra-abdominal bleeding
- elevation of portal pressure
Immunosuppression
- Infection
- Malignancy
Clinical Trial Results
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. 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.