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Islet Graft
Islet graft restores insulin-producing beta cell function by transplanting isolated pancreatic islets to replace lost endocrine tissue in patients with type 1 diabetes.
Islet graft restores insulin-producing beta cell function by transplanting isolated pancreatic islets to replace lost endocrine tissue in patients with type 1 diabetes. Used for Type 1 diabetes mellitus with severe hypoglycemia unawareness or brittle diabetes.
At a glance
| Generic name | Islet Graft |
|---|---|
| Also known as | human pancreatic islet transplantation |
| Sponsor | University Hospital, Grenoble |
| Drug class | Cell therapy / Tissue transplant |
| Modality | Biologic |
| Therapeutic area | Endocrinology / Diabetes |
| Phase | Phase 3 |
Mechanism of action
Pancreatic islets containing insulin-secreting beta cells are isolated from a donor pancreas and infused into the recipient's liver via the portal vein, where they engraft and begin producing insulin in response to blood glucose levels. This approach aims to restore physiologic glucose regulation and reduce or eliminate the need for exogenous insulin therapy. The procedure requires immunosuppression to prevent rejection of the allogeneic tissue.
Approved indications
- Type 1 diabetes mellitus with severe hypoglycemia unawareness or brittle diabetes
Common side effects
- Graft rejection
- Immunosuppression-related infections
- Portal vein thrombosis
- Bleeding at infusion site
- Hyperglycemia (graft failure)
Key clinical trials
- Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss
- Prevention of de Novo Allosensitization in Islet Transplant Recipients Following Complete Graft Loss (NA)
- Study of Glucose Tolerance Abnormalities Using Continuous Glucose Monitoring for the Identification of Early Loss of Pancreatic Islet Graft Function.
- 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)
- 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)
- Improving Islet Transplantation Outcomes With Gastrin for Type I Diabetes (PHASE1, PHASE2)
- Analysis of Graft Function Following Autologous Islet Transplantation
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 |