The Future of Islet Transplantation Is Now
Open accessAbstract
Milestones in the history of diabetes therapy include the discovery of insulin and successful methods of beta cell replacement including whole pancreas and islet cell transplantation options. While pancreas transplantation remains the gold standard for patients who have difficulty controlling their symptoms with exogenous insulin, islet allotransplantation is now able to provide similar results with some advantages that make it an attractive potential alternative. The Edmonton Protocol, which incorporated a large dose of islets from multiple donors with steroid-free immunosuppression helped to establish the modern era of islet transplantation almost 20 years ago. While islet allotransplantation is recognized around the world as a powerful clinical therapy for type 1 diabetes it is not yet recognized by the Federal Drug Administration of the United States. Large-scale clinical trials administered by the Clinical Islet Transplantation Consortium have recently demonstrated that the well-regulated manufacture of a human islet product transplanted into patients with difficult to control type 1 diabetes and with a history of severe hyperglycemic episodes can safely and efficaciously maintain glycemic balance and eliminate the most severe complications associated with diabetes. The results of these clinical trials have established a strong basis for licensure of clinical islet allotransplantation in the US. Recognition by the Federal Drug Administration would likely lead to third party reimbursement for islet allotransplantation as a therapeutic option in the United States and would make the treatment available to many more patients. The high costs of rampant diabetes justify the expense of the treatment, which is in-line with the costs of clinical pancreas transplantation. While much enthusiasm and hope is raised toward the development and optimization of stem cell therapy, the islet transplantation community should push toward licensure, if that means broader access of this procedure to patients who may benefit from it. Even as we prepare to take the first steps in that direction, we must acknowledge the new challenges that a shift from the experimental to clinical will bring. Clinical islet allotransplantation in the United States would be a game-changing event in the treatment of type 1 diabetes and also generate enthusiasm for continued research.
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Transplantation of pancreatic islets alone had limited success until the Edmonton Protocol in 2000 demonstrated that infusion of islets into the liver via the portal vein was sufficient to restore glucose homeostasis.
“Transplantation of pancreatic islets alone to restore β cell mass, however, had limited success until the development of the Edmonton Protocol in 2000, which demonstrated that infusion of islets into the liver via the portal vein was sufficient to restore glucose homeostasis.15,16”
From Developments in stem cell-derived islet replacement therapy for treating type 1 diabetes (2023) · cites this paper as [16]
“A new millennium begins” reports that the 2000 Edmonton Protocol achieved insulin independence in seven patients, a substantial improvement over earlier results. But “Islet transplantation in the twentieth century” reports insulin independence after intraportal transplantation before 2000, so the source does not support the implication that Edmonton first demonstrated that portal-vein islet infusion could restore glucose control. No page numbers are provided in our copy. (LLM, conf=0.88)
Experimental — accuracy not yet measuredThe Edmonton Protocol initial trial led to insulin independence of all seven patients 1 year after transplantation.
“Their initial trial led to insulin independence of all seven patients 1 year after transplantation, vastly improving previous islet transplantation outcomes due to optimization of their immunosuppression regimen as well as benefiting from improvements in islet isolation techniques.”
From Developments in stem cell-derived islet replacement therapy for treating type 1 diabetes (2023) · cites this paper as [16]
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The Future of Clinical Islet Transplantation in the United States
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Give Me an Islet… and I’m Yours
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- Authors
- Bottino, R., Knoll, M. F., Knoll, C. A., Bertera, S., & Trucco, M. M.
- Affiliations
- Allegheny Health Network (US)
- Corresponding author
- Bottino, Rita
- Venue
- Frontiers in Medicine
- Publisher
- Frontiers Media SA
- Published
- 2018-07-13
- Volume
- 5
- Pages
- 202-202
- ISSN
- 2296-858X (ISSN-L)
- PMC
- PMC6053495
- OpenAlex
- W2864122631
- Cited by
- 93
- References
- 94
- Citations by year
- 2026: 9 · 2025: 3 · 2024: 8 · 2023: 10 · 2022: 13 · 2021: 19 · 2020: 17 · 2019: 13 · 2018: 1
- FWCI
- 2.78
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Frontiers in Medicine (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion)
- Funders
- University of Pittsburgh
- Allegheny Health Network
- National Institutes of Health
- National Institute of Allergy and Infectious Diseases
- National Institute of Diabetes and Digestive and Kidney Diseases
- Topics
- Health Sciences › Medicine › Surgery › Pancreatic function and diabetes
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Genetics › Diabetes and associated disorders
- Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Diabetes Management and Research
- Keywords
- islet transplantation, allogeneic islet transplantation, type 1 diabetes, Edmonton protocol, steroid-free immunosuppression, reimbursement, stem cell therapy, pancreas transplantation, glycemic control
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