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Islet Cell Transplantation: How Effective Is It?. IN: LeRoith, D.; Vinik, A., eds. Controversies in Treating Diabetes: Clinical and Research Aspects. Totowa, NJ: Humana Press. 2008. pp 11-32.

This chapter about the effectiveness of islet transplantation is from a book that addresses diabetes controversies, specifically in the etiology and management of the disease. The authors of this chapter note that islet transplantation as a treatment for diabetes has shown great promise but has significant limitations. The chapter covers a brief history of islet transplantation, islet isolation, limits of the procedure, clinical islet transplantation, immunosuppression, the Edmonton advance, islet transplantation outcome follow-up, benefits, risk and limitations, new methods of beta-cell replacement and encapsulation, and endogenous beta-cell regeneration. Although islet transplantation can restore insulin independence to the patient with type 1 diabetes, nearly all patients must return to insulin therapy by 5 years after procedure due to loss of islet function. Other problems include the need for immunosuppression, an inadequate islet supply, risks associated with the portal vein cannulation, host sensitization against the donor islets, allogeneic islet effects on the surrounding host liver tissue, and great expense. The authors conclude by encouraging ongoing research in this area. 102 references.

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Adverse Events. IN: Collaborative Islet Transplant Registry Annual Report. Bethesda, MD: National Diabetes Information Clearinghouse. pp. 125-145.

The number of transplant centers performing clinical islet cell transplantation continues to increase, as does the number of centers participating in and reporting to the Collaborative Islet Transplant Registry (CITR). The CITR was founded in September 2001 to provide support for logistics, data capture, quality control monitoring, statistical design and analysis, and other Registry activities. This chapter from the second Annual Report of the CITR summarizes the adverse events the islet transplant programs experienced. The authors note that one center did not report any adverse event, so the data included may underrepresent true occurrences. The chapter includes the overall adverse event rate; the serious adverse event rate for islet-alone transplant recipients, 1 year post-infusion; a summary of adverse events by time periods following the first infusion procedure; events that were life-threatening or required hospitalization; and duration of hospitalization. Overall, 77 serious adverse events were reported to the Registry, with 22 percent of them classified as life-threatening and 58 percent requiring inpatient hospitalization. Almost 69 percent of the serious adverse events were classified as unrelated to the islet infusion procedure and 38 percent unrelated to the immunosuppression therapy. Ninety-five percent of the serious adverse events resolved with no residual effects. The chapter includes one page of text and 17 pages of figures and tables, graphically representing the information presented. Readers are referred to the Registry’s website, www.citregistry.org, for more information. 6 figures. 19 tables.

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Collaborative Islet Transplant Registry Annual Report. Bethesda, MD: National Diabetes Information Clearinghouse. 2005. 214 p.

The number of transplant centers performing clinical islet cell transplantation continues to increase, as does the number of centers participating in and reporting to the Collaborative Islet Transplant Registry (CITR). The CITR was founded in September 2001 to provide support for logistics, data capture, quality control monitoring, statistical design and analysis, and other Registry activities. This second Annual Report of the CITR describes the progress in islet or beta cell transplantation. The information is drawn from 19 North American islet transplant programs, representing 138 transplant recipients. The information is presented in four sections: a summary of Registry data; islet-transplant-alone recipient, donor, and outcome information; islet-after-kidney recipient, donor, and outcome information; and Registry data quality. The Report describes patient care, surgical experiences, follow-up care, complications, hypoglycemia, insulin independence, and immunosuppression in these patients. The Report provides data on the recipients, pancreas donors, pancreas preservation, islet processing, islet infusions, recipient treatment, post-transplant islet function, and adverse events. The Report is designed to provide information that can form the basis necessary for the development of islet transplantation as a curative therapy for type 1 diabetes. Readers are referred to the Registry’s website, www.citregistry.org, for more information. 210 figures.

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Towards a Cure for Type 1 Diabetes (And Other Autoimmune Diseases?). Infocus. 12(4): 1. December 2004.

This article, from the newsletter of the nonprofit association American Autoimmune Related Diseases Association, considers current research on type 1 diabetes and its potential cure. The article reports on the work of Denise Faustman and colleagues at Massachusetts General Hospital (MGH). The MGH team's approach identifies and selectively eliminates only the faulty cells of the immune system that mistakenly destroy healthy insulin-producing beta cells. Although the research was conducted on mice, the Federal Drug Administration and the MGH have approved plans for a clinical trial to correlate the mouse model findings to type 1 diabetes in humans. The article describes the animal research in detail, then describes how those findings may be tested in humans. The author concludes that the concept of islet regeneration without the need for islet cell transplantation or embryonic stem cells opens up a way to look for better treatments for type 1 diabetes.

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Collaborative Islet Transplant Registry Annual Report. Bethesda, MD: National Diabetes Information Clearinghouse. 2005. (CD-ROM)

The number of transplant centers performing clinical islet cell transplantation continues to increase, as does the number of centers participating in and reporting to the Collaborative Islet Transplant Registry (CITR). The CITR was founded in September 2001 to provide support for logistics, data capture, quality control monitoring, statistical design and analysis, and other Registry activities. This CD-ROM provides the second Annual Report of the CITR, supporting the mission of supporting progress and promoting safety in islet or beta cell transplantation. The disk contains the Annual Report in PDF format, March 2005 Case Report Forms in PDF format, and the figures and tables from the Annual Report in 210 PowerPoint slides. The information is drawn from 19 North American islet transplant programs, representing 138 transplant recipients. The Report describes patient care, surgical experiences, follow-up care, complications, hypoglycemia, insulin independence, and immunosuppression in these patients. The Report provides data on the recipients, pancreas donors, pancreas preservation, islet processing, islet infusions, recipient treatment, post-transplant islet function, and adverse events. The Report is designed to provide information that can form the basis necessary for the development of islet transplantation as a curative therapy for type 1 diabetes. Readers are referred to the Registry’s website, www.citregistry.org, for more information. 210 figures.

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Executive Summary. IN: Collaborative Islet Transplant Registry Annual Report. Bethesda, MD: National Diabetes Information Clearinghouse. pp. 1-3.

The number of transplant centers performing clinical islet cell transplantation continues to increase, as does the number of centers participating in and reporting to the Collaborative Islet Transplant Registry (CITR). The CITR was founded in September 2001 to provide support for logistics, data capture, quality control monitoring, statistical design and analysis, and other Registry activities. This introductory chapter from the second Annual Report of the CITR describes the progress in islet or beta cell transplantation. This chapter briefly summarizes the annual information that was drawn from 19 North American islet transplant programs, representing 138 transplant recipients. The information focuses on islet-transplant-alone recipients (n = 118), donor, and outcome information. The summary briefly describes patient care, surgical experiences, follow-up care, complications, hypoglycemia, insulin independence, and immunosuppression in these patients. The median age of islet-transplant-alone recipients was 41.6 years and duration of diabetes was 29 years. More than 66 percent of the recipients were female, and all had type 1 diabetes. The median age of the deceased donor for these recipients was 44 years (range 8 to 65 years); 53 percent of the donors were male, and approximately 66 percent were white. At the time of this report, follow-up evaluations had been completed for 112 out of 118 patients. Of these 112 patients, 55 (49.1 percent) are insulin independent, while 39 (34.8 percent) are insulin dependent. Fifteen patients (13.4 percent) have experienced graft failure, while three participants have an unknown insulin status. There is a striking decrease in the occurrence of severe hypoglycemic events subsequent to the first infusion. The majority of the recipients received daclizumab for induction and sirolimus combined with tacrolimus for maintenance immunosuppression. Information about adverse events, received from 18 of the 19 transplant centers, show that almost 74 percent of the recipients experienced at least one adverse event in year 1, while 36 percent experienced one or more serious adverse events in the first year post-transplant. Overall, 77 serious adverse events were reported to the Registry, with 22 percent (n = 17) of them classified as life-threatening and 58 percent (n = 45) requiring an inpatient hospitalization. Ninety-five percent of these adverse events were resolved without residual effects. Readers are referred to the Registry’s website, www.citregistry.org, for more information.

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Graft Function. IN: Collaborative Islet Transplant Registry Annual Report. Bethesda, MD: National Diabetes Information Clearinghouse. pp. 77-111.

The number of transplant centers performing clinical islet cell transplantation continues to increase, as does the number of centers participating in and reporting to the Collaborative Islet Transplant Registry (CITR). The CITR was founded in September 2001 to provide support for logistics, data capture, quality control monitoring, statistical design and analysis, and other Registry activities. This chapter from the second Annual Report of the CITR provides information about the analysis of graft function for the 188 patients who received islet transplant alone. It also provides information about insulin independence, initiation of insulin therapy, changes in insulin dosing, severe hypoglycemic events, metabolic measures, islet graft dysfunction, and diabetes-related secondary complications. The chapter includes four pages of text and 28 pages of figures and tables, graphically representing the information presented. Readers are referred to the Registry’s website, www.citregistry.org, for more information. 31 figures. 17 tables.

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Immunosuppressive and Other Medications. IN: Collaborative Islet Transplant Registry Annual Report. Bethesda, MD: National Diabetes Information Clearinghouse. pp. 63-76.

The number of transplant centers performing clinical islet cell transplantation continues to increase, as does the number of centers participating in and reporting to the Collaborative Islet Transplant Registry (CITR). The CITR was founded in September 2001 to provide support for logistics, data capture, quality control monitoring, statistical design and analysis, and other Registry activities. This chapter from the second Annual Report of the CITR summarizes the data reported to the Registry on immunosuppressive and other medications, such as anti-hypertensive and lipid lowering medications and adjunctive therapies. The chapter includes one page of text and 12 pages of figures and tables, graphically representing the information presented. The majority of islet-alone recipients at time of first infusion were on a daclizumab, sirolimus, and tacrolimus immunosuppression regimen. Tables show the other immunosuppression regimens that have been used, dosing for these medications, and T-cell antibodies used for induction at the first infusion, as well as maintenance therapy regimens and dosing information. Prior to the first infusion, 32 percent of the recipients were on at least one anti-hypertensive medication, and 16 percent were on a lipid-lowering medication. For adjunctive therapies, at the time of their first infusion, more than 91 percent of recipients used an antibiotic, 81 percent used heparin, 81 percent used vitamin supplements, and 80 percent used antivirals. Readers are referred to the Registry’s website, www.citregistry.org, for more information. 4 figures. 9 tables.

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Islet After Kidney Transplant Information Summary. IN: Collaborative Islet Transplant Registry Annual Report. Bethesda, MD: National Diabetes Information Clearinghouse. pp. 147-203.

The number of transplant centers performing clinical islet cell transplantation continues to increase, as does the number of centers participating in and reporting to the Collaborative Islet Transplant Registry (CITR). The CITR was founded in September 2001 to provide support for logistics, data capture, quality control monitoring, statistical design and analysis, and other Registry activities. This chapter from the second Annual Report of the CITR provides information about islet-after-kidney-transplant recipients (n = 19 recipients, from three islet transplant programs). The median age of the islet-after-kidney-transplant recipient was 47.7 years, and the median duration of diabetes was 31 years. Compared with islet-alone recipients, islet-after-kidney recipients are older, weigh less, and have a lower body mass index (BMI). Almost 90 percent of the recipients were either on an insulin pump or were taking three or more insulin injections per day. The chapter also provides information about islet infusion, donors, pancreas procurement and islet processing, immunosuppression medications, graft function, severe hypoglycemic events, laboratory tests, and adverse events. The chapter includes four pages of text and 50 pages of figures and tables, graphically representing the information presented. Readers are referred to the Registry’s website, www.citregistry.org, for more information. 35 figures. 45 tables.

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Methods Summary. IN: Collaborative Islet Transplant Registry Annual Report. Bethesda, MD: National Diabetes Information Clearinghouse. pp. 5-8.

The number of transplant centers performing clinical islet cell transplantation continues to increase, as does the number of centers participating in and reporting to the Collaborative Islet Transplant Registry (CITR). The CITR was founded in September 2001 to provide support for logistics, data capture, quality control monitoring, statistical design and analysis, and other Registry activities. This introductory chapter from the second Annual Report of the CITR describes the progress in islet or beta cell transplantation. This introductory chapter briefly summarizes the methods used to gather annual information from the 19 North American islet transplant programs, representing 138 transplant recipients. The chapter describes how CITR uses a set of web-based forms to capture pertinent information that help characterize and follow trends in safety and efficacy of islet transplantation, paying particular attention to islet processing, transplant techniques, and treatment protocols. This chapter also defines several key terms used by CITR that are used in the Annual Report figures and tables. Abbreviations and other symbols used in the Annual Report are also defined in this chapter. Readers are referred to the Registry’s website, www.citregistry.org, for more information and can request a copy of the data collection forms from the CITR Coordinating Center (citr@emmes.com).

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