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Allogeneic Islets of Langerhans · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Allogeneic islet transplantation with anti-thymocyte globulin induction and cyclosporine and RAD maintenance immunosuppression |
| Name | Type | Description |
|---|---|---|
| Allogeneic Islets of Langerhans | BIOLOGICAL | Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. First infusion to contain at least 5,000 islet equivalents/kg body weight. Subsequent infusions to contain at least 3,000 islet equivalents/kg body weight. |
| Everolimus | DRUG | Loading dose of 3 mg PO on day -2 relative to transplant, followed at least 12 hours later by dose of 1.5 mg PO BID. The daily dose will be adjusted according to the whole blood 12-hr trough to target 3-15 ng/ml for the first 3 months and 3-12 ng/ml thereafter. |
| anti-thymocyte globulin | DRUG | A total of 6 mg/kg IV over 12 hours on days -2, -1, 0, +1, and +2. The dose will be 0.5 mg/kg on day -2, 1.0 mg/kg on day -1, and 1.5 mg/kg on days 0, +1, and +2. |
| Cyclosporine | DRUG | Cyclosporine started on day +1 relative to the first islet transplant. Initial dose of 3 mg/kg/day administered in 2 divided doses; then adjusted to maintain target levels of 400 (350-500) ng/mL for the first three months following islet transplant and 300 (200-350) ng/mL thereafter. |
Inclusion Criteria: * Primary islet allotransplant * Patients with type 1 diabetes mellitus under intensive insulin management * Age 18 or older * Ability to give written informed consent Exclusion Criteria: * Age less than 18 years. * BMI \>26 kg/m2. * Insulin requirement of \> 50 IU per day. * ...
Allogeneic Islets of Langerhans is an investigational therapy being studied for Type 1 Diabetes Mellitus, specifically in patients who also experience hypoglycemia. It is currently in Phase 1 clinical development and is not yet approved by the FDA.
Allogeneic Islets of Langerhans is being developed by Novartis AG, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The therapy is in Phase 1 clinical development for Type 1 Diabetes Mellitus.
Allogeneic Islets of Langerhans is in Phase 1 clinical development. It is an investigational therapy for Type 1 Diabetes Mellitus and has not been approved by regulatory authorities. One Phase 1 trial has been completed.
Allogeneic Islets of Langerhans has been studied in one clinical trial, identified as NCT00286624, titled "Anti-Thymocyte Globulin, Cyclosporine, and RAD in Islet Transplantation." This Phase 1 trial was completed in the United States and enrolled 6 participants with Type 1 Diabetes Mellitus and hypoglycemia.
Allogeneic Islets of Langerhans refers to donor-derived islet cells used in transplantation. The clinical trial NCT00286624 investigated these cells in combination with immunosuppressive agents for Type 1 Diabetes Mellitus. The therapy is in Phase 1 development by Novartis AG.