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Islets of Langerhans transplantation
Islets of Langerhans transplantation is a Cell therapy / Allogeneic transplant Biologic drug developed by CellTrans Inc.. It is currently in Phase 3 development for Type 1 diabetes mellitus with severe hypoglycemia unawareness or brittle diabetes, Type 1 diabetes with impaired kidney function (simultaneous pancreatic islet and kidney transplant). Also known as: Islets of Langerhan (Islets), Basiliximab (Simulect®), Tacrolimus (Prograf®), Sirolimus (Rapamune®).
Islet transplantation restores functional insulin-producing beta cells to the pancreas, enabling endogenous insulin secretion and glucose homeostasis in patients with type 1 diabetes.
Islet transplantation restores functional insulin-producing beta cells to the pancreas, enabling endogenous insulin secretion and glucose homeostasis in patients with type 1 diabetes. Used for Type 1 diabetes mellitus with severe hypoglycemia unawareness or brittle diabetes, Type 1 diabetes with impaired kidney function (simultaneous pancreatic islet and kidney transplant).
At a glance
| Generic name | Islets of Langerhans transplantation |
|---|---|
| Also known as | Islets of Langerhan (Islets), Basiliximab (Simulect®), Tacrolimus (Prograf®), Sirolimus (Rapamune®), Etanercept(Enbrel®) |
| Sponsor | CellTrans Inc. |
| Drug class | Cell therapy / Allogeneic transplant |
| Modality | Biologic |
| Therapeutic area | Endocrinology / Diabetes |
| Phase | Phase 3 |
Mechanism of action
This procedure involves isolation and transplantation of pancreatic islets (clusters of insulin-secreting beta cells) from a donor pancreas into a recipient with type 1 diabetes. The transplanted islets engraft in the recipient's liver or other sites and begin producing insulin in response to blood glucose levels, potentially eliminating the need for exogenous insulin therapy. Success requires immunosuppression to prevent rejection of the allogeneic tissue.
Approved indications
- Type 1 diabetes mellitus with severe hypoglycemia unawareness or brittle diabetes
- Type 1 diabetes with impaired kidney function (simultaneous pancreatic islet and kidney transplant)
Common side effects
- Graft failure / loss of insulin independence
- Immunosuppression-related infections
- Immunosuppression-related malignancy
- Bleeding at transplant site
- Portal vein thrombosis
- Hyperglycemia recurrence
Key clinical trials
- SGLT2i Therapy in Islet Transplantation (SIT) (PHASE4)
- Sequential Transplantation of UCBSCs and Islet Cells in Children and Adolescents With Monogenic Immunodeficiency T1DM (NA)
- Study of Glucose Tolerance Abnormalities Using Continuous Glucose Monitoring for the Identification of Early Loss of Pancreatic Islet Graft Function.
- Pancreatic Islet Transplantation Into the Anterior Chamber of the Eye (PHASE1, PHASE2)
- Safety, Tolerability, and Efficacy of Immunomodulation With A Monoclonal Antibody Against CD40L in Combination With Transplanted Islet Cells in Adults With Brittle Type 1 Diabetes Mellitus (T1D) (PHASE1, PHASE2)
- Pancreatic Islets and Parathyroid Gland Co-transplantation for Treatment of Type 1 Diabetes (PHASE1, PHASE2)
- A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus (PHASE1, PHASE2)
- A Safety, Tolerability and Efficacy Study of Sernova's Cell Pouch™ for Clinical Islet Transplantation (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Islets of Langerhans transplantation CI brief — competitive landscape report
- Islets of Langerhans transplantation updates RSS · CI watch RSS
- CellTrans Inc. portfolio CI
Frequently asked questions about Islets of Langerhans transplantation
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Related
- Drug class: All Cell therapy / Allogeneic transplant drugs
- Manufacturer: CellTrans Inc. — full pipeline
- Therapeutic area: All drugs in Endocrinology / Diabetes
- Indication: Drugs for Type 1 diabetes mellitus with severe hypoglycemia unawareness or brittle diabetes
- Indication: Drugs for Type 1 diabetes with impaired kidney function (simultaneous pancreatic islet and kidney transplant)
- Also known as: Islets of Langerhan (Islets), Basiliximab (Simulect®), Tacrolimus (Prograf®), Sirolimus (Rapamune®), Etanercept(Enbrel®)
- Compare: Islets of Langerhans transplantation vs similar drugs
- Pricing: Islets of Langerhans transplantation cost, discount & access