{ "data": { "asOf": "2026-10-30T22:25:00.732Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT01909245", "title": "Islet Cell Transplant for Type 1 Diabetes", "scientificTitle": "Islet Transplantation Using a T-Cell Depleting Immunosuppression Induction Regimen", "status": "active", "studyType": "interventional", "phase": [ "PHASE2" ], "conditions": [ "Type 1 Diabetes Mellitus" ], "interventions": [ { "name": "Allogenic Human Islet Cells", "type": "BIOLOGICAL", "description": "Intraportal (into the liver) infusion of islet cells, with a maximum of three islet transplants." }, { "name": "Immunosuppressive Agents", "type": "DRUG", "description": "Anti-rejection medications (to prevent the body from rejecting the islet cells) and other medications to guard against infection and support participant health and/or the health of the transplanted islets." }, { "name": "Gastrin 17", "type": "DRUG", "description": "Gastrin-17 (or GAST-17) - a gut hormone injected under the skin for 30 days (optional treatment for islet dysfunction)." } ], "sponsor": { "name": "City of Hope Medical Center", "type": "OTHER" }, "locations": [ { "city": "Duarte", "country": "United States", "facility": "City of Hope Medical Center" } ], "outcomes": { "other": [ "Proportion of subjects experiencing reduction/elimination of hypoglycemic episodes", "Duration of insulin independence", "Proportion of subjects who maintain a positive c-peptide secretion response to glucose/glucagon stimulation", "Change in average daily insulin use compared to baseline", "Decline in insulin intake/100,000 IEQ infused", "Insulin secretion during Intravenous Glucose Tolerance Test (IVGTT), IVGTT+arginine stimulation (IVGTT+AST), Maximum Stimulated Insulin Secretion test (MSIS), and/or Mixed Meal Tolerance Test (MMTT)", "Rate of alloimmune rejection", "Rate of autoimmune reactivation", "Incidence and severity of adverse events related to islet transplant procedure", "Incidence and severity of adverse events related to immunosuppression", "Incidence of change in immunosuppression drug regimen", "Incidence of immune sensitization defined by presence of anti-HLA antibodies post-transplant that were absent pre-transplant", "Incidence of discontinuation of immunosuppression", "Improvement in glucose time within range during continuous glucose monitoring", "Improvement in Personal Glycemic State (PGS) score calculated from continuous glucose monitoring", "Incidence of Gastrin-17 use for treatment of islet graft dysfunction AND incidence of change or early discontinuation of Gastrin-17 treatment" ], "primary": [ "Proportion of subjects who are insulin independent, hypoglycemia free, AND with hemoglobin A1c < or = 6.5% at 1 year post-transplant", "Proportion of subjects who are insulin independent, hypoglycemia free, AND with hemoglobin A1c < or = 6.5% at 2 years post-transplant", "Proportion of subjects who are insulin independent, hypoglycemia free, AND with hemoglobin A1c < or = 6.5% at 5 years post-transplant" ], "secondary": [ "Proportion of subjects who are free of severe hypoglycemic episodes AND have a hemoglobin A1c < or = 7.0%" ] }, "eligibility": { "sex": "ALL", "criteria": "Three different categories of patients with Type 1 Diabetes will be considered for study participation:\n\n* Naïve islet transplant alone (nITA) candidates: T1D patients complicated by frequent/severe hypoglycemia, hypoglycemia unawareness, AND/OR otherwise unstable blood glucose control who have not received a previous transplant (except for a failed pancreas more than 6 months prior to screening)\n* Repeat transplant (RT) candidates: T1D patients who have received two or fewer previous islet transplants \\> 1 month prior to screening, but continue to require exogenous insulin treatment or have an HbA1c \\> 6.5%\n* Islet after kidney transplant (IAK) candidates: T1D patients with a history of successful renal transplant \\> 3 months prior to screening\n\nInclusion criteria for all candidates:\n\n1. Age 18-68 years\n2. Type 1 diabetes mellitus for at least 5 years\n3. Ability and willingness to comply with post-transplant regimen, including taking anti-rejection medications, use of reliable contraception, frequent clinic visits, lab tests, careful recording of blood glucose values, insulin doses and medications, and completing detailed follow-up studies\n\n Additional Inclusion Criteria nITA Candidates Only\n4. Unstable blood sugar control characterized by:\n\n Frequent hypoglycemia (blood glucose ≤ 54 mg/dl more than once per week) -AND/OR- Hypoglycemia unawareness (Clarke score of 4 or more) -AND/OR- One or more severe hypoglycemic episodes in 12 months preceding enrollment. -AND/OR- Erratic blood glucose levels that interfere with daily activities -AND/OR- One or more hospital visits for diabetic ketoacidosis in the 12 months preceding enrollment\n\n Additional Inclusion Criteria for RT Candidates Only\n5. One or two or previous islet transplants \\> 1 month prior to screening with continuing insulin requirements and/or HbA1c \\> 6.5%\n\n Additional Inclusion Criteria for IAK Candidates Only\n6. Successful kidney transplant \\> 3 months prior to screening\n7. Stable maintenance immunosuppression consisting of tacrolimus alone or in conjunction with sirolimus, mycophenolate mofetil, myfortic or azathoprine; or cyclosporine in conjunction with sirolimus, mycophenolate mofetil, or myfortic +/- ≤ 10 mg/day corticosteroids\n8. No history of acute rejection related to kidney graft in last 12 months and low risk of rejection\n9. Under continuing care of physician for kidney graft, who has provided letter in support of candidate's consideration for study participation\n\nExclusion Criteria:\n\n1. Body Mass Index (BMI) \\> 33\n2. Insulin requirements \\> 1.2 units/kg/day\n3. Known sensitization to both rATG -and- alemtuzumab\n4. Significant kidney dysfunction\n5. Significant liver/gall bladder disease\n6. Significant cardiovascular disease\n7. Active proliferative retinopathy\n8. High blood pressure despite appropriate treatment\n9. High cholesterol/triglycerides despite appropriate treatment\n10. Anemia or other blood disorders that require medical treatment\n11. WBC \\<3,000/ul\n12. Increased risk of bleeding, other chronic hemostasis disorders, or treatment with chronic anticoagulant therapy\n13. Recent unresolved acute infection (except for mild skin infection or nail fungal infection), or chronic infection\n14. Epstein-Barr Virus (EBV) IgG negative\n15. Any history of malignancy, except for completely resected squamous or basal cell carcinoma of the skin or in situ cancer of the cervix\n16. Recent history of non-adherence to medical treatment, or inability to demonstrate capacity to comply with strict blood glycemic control and insulin therapy\n17. Psychiatric illness that is untreated, or likely to interfere significantly with study compliance despite treatment\n18. Previous organ/tissue transplant, except as noted above\n19. Administration of live attenuated vaccines within 2 months of enrollment\n20. Presence of a chronic disease that must be chronically treated with a contraindicated agent\n21. Use of investigational agents within four weeks of enrollment\n22. Active alcohol or substance abuse, including cigarette smoking\n23. Pregnant women, women intending future pregnancy, women of reproductive potential who are unable or unwilling to follow effective contraceptive measures prior to study entry and for as long as they are on immunosuppression medication, and women presently breast feeding are excluded\n24. Individuals without health insurance\n25. History of gastric bypass\n26. 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