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| ID | Type | Description | Link |
|---|---|---|---|
| BB-IND 11228 |
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The purpose of this study is to learn about the safety of islet transplantation when performed after kidney transplantation, which may provide more normal control of blood sugar without the need for insulin shots. Islets are special clusters of cells within the pancreas that produce insulin. These cells will be obtained from cadaver (non-living) donors and given to subjects by vein.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Allogenic islet cells (human, U. Chicago) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogenic islet cells (human, U. Chicago) | Biological | Human allogenic islet cells. Immunosuppression varies but may include prograf, cellcept, sirolimus, prednisone. Dosage will vary per patient based on weight. Patients will receive immunosuppression medications while islet cells are functioning. |
| Measure | Description | Time Frame |
|---|---|---|
| HbAlc <6.5% and an absence of severe hypoglycemic events | The proportion of subjects with both an HbAlc <6.5% and an absence of severe hypoglycemic events at 1 year after the first islet transplant or a reduction in HbAlc of at least 1 point and an absence of severe hypoglycemic events at 1 year after the first islet transplant. | 1 year after transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| HbAlc < 6.5% and an absence of severe hypoglycemic events measured after last transplant | The primary endpoint measured at one year after the last islet transplant. That is the proportion of subjects with both an HbAlc < 6.5% and an absence of severe hypoglycemic events at 1 year after the last islet transplant or a reduction in HbAlc of 1 point and an absence of severe hypoglycemia at 1 year after the last islet transplant. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lindsay Basto, RN, BSN | Contact | 773-702-2504 | Lindsay.Basto@uchospitals.edu | |
| Piotr Witkowski, MD, PhD | Contact | (773) 702-2447 | pwitkowski@surgery.bsd.uchicago.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Recruiting | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38806704 | Background | Pathak P, Thampy R, Schat R, Bellin M, Beilman G, Hosseini N, Spilseth B. Transplantation for type 1 diabetes: radiologist's primer on islet, pancreas and pancreas-kidney transplantation imaging. Abdom Radiol (NY). 2024 Oct;49(10):3637-3665. doi: 10.1007/s00261-024-04368-8. Epub 2024 May 28. | |
| 38917621 | Background |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Intraportal infusion of islet cells | Procedure | Intraportal infusion of islet cell through the portal vein in the liver. |
|
| 365 ± 14 days after the last islet transplant |
| Gariani K, Peloso A, Galani V, Haidar F, Wassmer CH, Kumar R, Lacin EH, Olivier V, Prada P, Compagnon P, Berishvili E, Berney T. Effect of islet alone or islets after kidney transplantation on quality of life in type 1 diabetes: A systematic review. Transplant Rev (Orlando). 2024 Dec;38(4):100870. doi: 10.1016/j.trre.2024.100870. Epub 2024 Jun 21. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |